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eosdrel_org | Kausalzusammenhang Tod und IMP | integer | 8 | Kausalzusammenhang Tod und IMP | 1, 2 | possible, not possible | End of Study | ||||
F28SURV | Patient verstorben? | integer | 8 | Patient verstorben? | 0, 1 | no, yes | Follow up Tag 28 | ||||
F28DREAS | reason of death | integer | 8 | reason of death | 1, 2, 3, 7, 9, 10, 99 | refractory septic shock, sepsis induced multi organ failure, acute respiratory insufficiency, other primary disease, Kardiale Ursache (Infarkt\, kardiogener Schock\, Arrhytmie), Lungenembolie, othre reason | Follow up Tag 28 | ||||
F28DROTH | Klartext zu anderer Todesursache | string | 720 | Klartext zu anderer Todesursache | Follow up Tag 28 | ||||||
F28DREL | Kausalzusammenhang Tod und IMP | integer | 8 | Kausalzusammenhang Tod und IMP | 1, 2 | possible, not possible | Follow up Tag 28 | ||||
F28STAT | whereabouts day 28 | integer | 8 | whereabouts day 28 | 1, 2, 3, 4, 5, 6, 7, 8 | auf ITS: seit Studieneinschluss, auf ITS: durch Wiederaufnahme, im Krankenhaus: seit Studieneinschluss, im Krankenhaus: durch Wiederaufnahme, in anderem Krankenhaus, Rehabilitation, Pflegeheim, zu Hause | Follow up Tag 28 | ||||
sgs_ss_f28 | Septischer Schock | integer | 8 | Septischer Schock | 0, 1 | no, yes | Follow up Tag 28 | ||||
ss_occ_f28 | Septic Shock occured | integer | 8 | Septic Shock occured | 1, 2, 3, 4 | newly occured, ongoing since previous day, ongoing since day 14, ongoing since day 28 | Follow up Tag 28 | ||||
ssong_f28 | Septischer Schock andauernd | integer | 8 | Septischer Schock andauernd | 0, 1 | no, yes | Follow up Tag 28 | ||||
sshcor_f28 | niedrig dosiertes Hydrocortison | integer | 8 | niedrig dosiertes Hydrocortison | 0, 1 | no, yes | Follow up Tag 28 | ||||
F28NT | Tage mit Nierenersatzverfahren | d | integer | 3 | Tage mit Nierenersatzverfahren | Follow up Tag 28 | |||||
F28BT | ventilator days | d | integer | 3 | ventilator days | Follow up Tag 28 | |||||
F28WFAIL | Weaning Failure | integer | 8 | Weaning Failure | 0, 1 | no, yes | Follow up Tag 28 | ||||
F28MRC | klinisch relevante Muskelschwäche | integer | 8 | klinisch relevante Muskelschwäche | 0, 1 | no, yes | Follow up Tag 28 | ||||
F28DELIR | Delir | integer | 8 | Delir | 0, 1 | no, yes | Follow up Tag 28 | ||||
infneuyn_f28 | neue Infektion | integer | 8 | neue Infektion | 0, 1 | no, yes | Follow up ITS-Entlassung | ||||
FITSURV | Patient verstorben? | integer | 8 | Patient verstorben? | 0, 1 | no, yes | Follow up ITS-Entlassung | ||||
FITDREAS | reason of death | integer | 8 | reason of death | 1, 2, 3, 7, 9, 10, 99 | refractory septic shock, sepsis induced multi organ failure, acute respiratory insufficiency, other primary disease, cardial (infarction\, cardiogenic shock\, arrhytmia), pulmonary embolism, othre reason | Follow up ITS-Entlassung | ||||
FITDROTH | Klartext zu anderer Todesursache | string | 720 | Klartext zu anderer Todesursache | Follow up ITS-Entlassung | ||||||
FITDREL | Kausalzusammenhang Tod und IMP | integer | 8 | Kausalzusammenhang Tod und IMP | 1, 2 | possible, not possible | Follow up ITS-Entlassung | ||||
FITSTAT | whereabouts after ICU discharge | integer | 8 | whereabouts after ICU discharge | 1, 2, 3, 4, 5, 6, 7, 8 | auf ITS: seit Studieneinschluss, auf ITS: durch Wiederaufnahme, im Krankenhaus: seit Studieneinschluss, im Krankenhaus: durch Wiederaufnahme, in anderem Krankenhaus, Rehabilitation, Pflegeheim, zu Hause | Follow up ITS-Entlassung | ||||
sgs_ss_fit | Septischer Schock | integer | 8 | Septischer Schock | 0, 1 | no, yes | Follow up ITS-Entlassung | ||||
ss_occ_fit | Septic Shock occured | integer | 8 | Septic Shock occured | 1, 2, 3, 4 | newly occured, ongoing since previous day, ongoing since day 14, ongoing since day 28 | Follow up ITS-Entlassung | ||||
ssong_fit | Septischer Schock andauernd | integer | 8 | Septischer Schock andauernd | 0, 1 | no, yes | Follow up ITS-Entlassung | ||||
sshcor_fit | niedrig dosiertes Hydrocortison | integer | 8 | niedrig dosiertes Hydrocortison | 0, 1 | no, yes | Follow up ITS-Entlassung | ||||
FITNT | Tage mit Nierenersatzverfahren | d | integer | 3 | Tage mit Nierenersatzverfahren | Follow up ITS-Entlassung | |||||
FITBT | ventilator days | d | integer | 3 | ventilator days | Follow up ITS-Entlassung | |||||
FITWFAIL | Weaning Failure | integer | 8 | Weaning Failure | 0, 1 | no, yes | Follow up ITS-Entlassung | ||||
FITMRC | klinisch relevante Muskelschwäche | integer | 8 | klinisch relevante Muskelschwäche | 0, 1 | no, yes | Follow up ITS-Entlassung | ||||
FITDELIR | Delir | integer | 8 | Delir | 0, 1 | no, yes | Follow up ITS-Entlassung | ||||
FKHSURV | Patient verstorben? | integer | 8 | Patient verstorben? | 0, 1 | no, yes | Follow up KH-Entlassung | ||||
FKHDREAS | reason of death | integer | 8 | reason of death | 1, 2, 3, 7, 9, 10, 99 | refractory septic shock, sepsis induced multi organ failure, acute respiratory insufficiency, other primary disease, cardial (infarction\, cardiogenic shock\, arrhytmia), pulmonary embolism, othre reason | Follow up KH-Entlassung | ||||
FKHDROTH | Klartext zu anderer Todesursache | string | 720 | Klartext zu anderer Todesursache | Follow up KH-Entlassung | ||||||
FKHDREL | Kausalzusammenhang Tod und IMP | integer | 8 | Kausalzusammenhang Tod und IMP | 1, 2 | possible, not possible | Follow up KH-Entlassung | ||||
FKHSTAT | whereabouts after hospital discharge | integer | 8 | whereabouts after hospital discharge | 1, 2, 3, 4, 5, 6, 7, 8 | auf ITS: seit Studieneinschluss, auf ITS: durch Wiederaufnahme, im Krankenhaus: seit Studieneinschluss, im Krankenhaus: durch Wiederaufnahme, in anderem Krankenhaus, Rehabilitation, Pflegeheim, zu Hause | Follow up KH-Entlassung | ||||
F90SURV | Patient verstorben? | integer | 8 | Patient verstorben? | 0, 1 | no, yes | Follow up Tag 90 | ||||
F90DREAS | reason of death | integer | 8 | reason of death | 1, 2, 3, 7, 9, 10, 99 | refractory septic shock, sepsis induced multi organ failure, acute respiratory insufficiency, other primary disease, Kardiale Ursache (Infarkt\, kardiogener Schock\, Arrhytmie), Lungenembolie, othre reason | Follow up Tag 90 | ||||
F90DROTH | Klartext zu anderer Todesursache | string | 720 | Klartext zu anderer Todesursache | Follow up Tag 90 | ||||||
F90DREL | Kausalzusammenhang Tod und IMP | integer | 8 | Kausalzusammenhang Tod und IMP | 1, 2 | possible, not possible | Follow up Tag 90 | ||||
F90STAT | whereabouts day 90 | integer | 8 | whereabouts day 90 | 1, 2, 3, 4, 5, 6, 7, 8 | auf ITS: seit Studieneinschluss, auf ITS: durch Wiederaufnahme, im Krankenhaus: seit Studieneinschluss, im Krankenhaus: durch Wiederaufnahme, in anderem Krankenhaus, Rehabilitation, Pflegeheim, zu Hause | Follow up Tag 90 | ||||
F6MSURV | Patient verstorben? | integer | 8 | Patient verstorben? | 0, 1 | no, yes | Follow up 6 Monate | ||||
F6MDREAS | reason of death | integer | 8 | reason of death | 1, 2, 3, 7, 9, 10, 99 | refractory septic shock, sepsis induced multi organ failure, acute respiratory insufficiency, other primary disease, cardial (infarction\, cardiogenic shock\, arrhytmia), pulmonary embolism, othre reason | Follow up 6 Monate | ||||
F6MDROTH | Klartext zu anderer Todesursache | string | 720 | Klartext zu anderer Todesursache | Follow up 6 Monate | ||||||
F6MDREL | Kausalzusammenhang Tod und IMP | integer | 8 | Kausalzusammenhang Tod und IMP | 1, 2 | possible, not possible | Follow up 6 Monate | ||||
F6MSTAT | whereabouts day 180 | integer | 8 | whereabouts day 180 | 1, 2, 3, 4, 5, 6, 7, 8 | auf ITS: seit Studieneinschluss, auf ITS: durch Wiederaufnahme, im Krankenhaus: seit Studieneinschluss, im Krankenhaus: durch Wiederaufnahme, in anderem Krankenhaus, Rehabilitation, Pflegeheim, zu Hause | Follow up 6 Monate | ||||
eosreas | Grund Studienende | integer | 8 | Grund Studienende | 1, 2, 3, 4, 5, 6, 7, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 | EOT per protocol on day 11, Septic Shock before study treatment, septic shock after start of IMP, discharged to ward, discharged to other ICU, discharged to other hospital, SAE related to study treatment, investigator decision, IC withdrawn, IC not obtainable, IC refused by patient, IC refused by court appointed guardian, Death (under IMP), Death (after IMP), end of daily docu acc to protocol d14, IC refused by legal representative, discharged (home) | End of Study | ||||
eosarzt_txt | Ärztliche Entscheidung EOS | string | 720 | Ärztliche Entscheidung EOS | End of Study | ||||||
eosereasoth | anderer Grund Studienende | string | 720 | anderer Grund Studienende | End of Study | ||||||
eosdreas | Todesursache EOS | integer | 8 | Todesursache EOS | 1, 2, 3, 7, 9, 10, 99 | refractory septic shock, sepsis induced multi organ failure, acute respiratory insufficiency, other primary disease, Kardiale Ursache (Infarkt\, kardiogener Schock\, Arrhytmie), Lungenembolie, othre reason | End of Study | ||||
eosdrel | Kausalzusammenhang zw Tod und IMP | integer | 8 | Kausalzusammenhang zw Tod und IMP | 1, 2 | possible, not possible | End of Study | ||||
eosdreasoth | andere Todesursache EOS | string | 720 | andere Todesursache EOS | End of Study | ||||||
arm | Treatment Arm | integer | 8 | Treatment Arm | 1, 2 | Control, Trial | Therapiearm | ||||
anz_sirs | No of SIRS-Criteria | integer | 8 | No of SIRS-Criteria | Einschluss - SIRS | ||||||
histsurg | History of Surgery | integer | 8 | History of Surgery | 0, 1 | no, yes | Operative Eingriffe | ||||
anz_od | No of organ dysfunction | integer | 8 | No of organ dysfunction | Einschluss - Organdysfunktion | ||||||
sevsepss | Severity of Sepsis | integer | 8 | Severity of Sepsis | 0, 1, 2 | No severe sepsis [excl crit], Severe sepsis, Septic shock [excl crit] | Schweregrad der Sepsis | ||||
grinf | Infection | integer | 8 | Infection | 0, 1 | no, yes | Organsystembezogene Gründe | ||||
grkard | Cardiological | integer | 8 | Cardiological | 0, 1 | no, yes | Organsystembezogene Gründe | ||||
grhep | Hepatic | integer | 8 | Hepatic | 0, 1 | no, yes | Organsystembezogene Gründe | ||||
grgast | Gastrointestinal | integer | 8 | Gastrointestinal | 0, 1 | no, yes | Organsystembezogene Gründe | ||||
grresp | Respiratory | integer | 8 | Respiratory | 0, 1 | no, yes | Organsystembezogene Gründe | ||||
grneur | Neurological | integer | 8 | Neurological | 0, 1 | no, yes | Organsystembezogene Gründe | ||||
grren | Renal | integer | 8 | Renal | 0, 1 | no, yes | Organsystembezogene Gründe | ||||
grhaem | Hematological | integer | 8 | Hematological | 0, 1 | no, yes | Organsystembezogene Gründe | ||||
grmeta | Metabolic | integer | 8 | Metabolic | 0, 1 | no, yes | Organsystembezogene Gründe | ||||
groth | Other Reason | integer | 8 | Other Reason | 0, 1 | no, yes | Organsystembezogene Gründe | ||||
death | Deceased | integer | 8 | Deceased | 0, 1 | no, yes | Überleben und septischer Schock | ||||
dsd | Day of Death | d | integer | 8 | Day of Death | Überleben und septischer Schock | |||||
dreas | Reason of Death | integer | 8 | Reason of Death | 1, 2, 3, 7, 9, 10, 99 | refractory septic shock, sepsis induced multi organ failure, acute respiratory insufficiency, other primary disease, cardial (infarction\, cardiogenic shock\, arrhytmia), pulmonary embolism, othre reason | Überleben und septischer Schock | ||||
drel | Causal Relationship Death and IMP | integer | 8 | Causal Relationship Death and IMP | 1, 2 | possible, not possible | Überleben und septischer Schock | ||||
lconsd | Day of last contact | d | integer | 8 | Day of last contact | Überleben und septischer Schock | |||||
death_14 | 14d mortality | integer | 8 | 14d mortality | 0, 1 | Survivor, Non-Survivor | Überleben und septischer Schock | ||||
death_28 | 28d mortality | integer | 8 | 28d mortality | 0, 1 | Survivor, Non-Survivor | Überleben und septischer Schock | ||||
d28reas | reason for death | integer | 8 | reason for death | 0, 1, 2, 3, 7, 9, 10, 99 | Survivor, refractory septic shock, sepsis induced multi organ failure, acute respiratory insufficiency, other primary disease, Kardiale Ursache (Infarkt\, kardiogener Schock\, Arrhytmie), Lungenembolie, othre reason | Überleben und septischer Schock | ||||
death_90 | 90d mortality | integer | 8 | 90d mortality | 0, 1 | Survivor, Non-Survivor | Überleben und septischer Schock | ||||
d90reas | reason for death | integer | 8 | reason for death | 0, 1, 2, 3, 7, 9, 10, 99 | Survivor, refractory septic shock, sepsis induced multi organ failure, acute respiratory insufficiency, other primary disease, Kardiale Ursache (Infarkt\, kardiogener Schock\, Arrhytmie), Lungenembolie, othre reason | Überleben und septischer Schock | ||||
death_180 | 180d mortality | integer | 8 | 180d mortality | 0, 1 | Survivor, Non-Survivor | Überleben und septischer Schock | ||||
d180reas | reason for death | integer | 8 | reason for death | 0, 1, 2, 3, 7, 9, 10, 99 | Survivor, refractory septic shock, sepsis induced multi organ failure, acute respiratory insufficiency, other primary disease, Kardiale Ursache (Infarkt\, kardiogener Schock\, Arrhytmie), Lungenembolie, othre reason | Überleben und septischer Schock | ||||
pm_giv | IMP given | integer | 8 | IMP given | 0, 1 | no, yes | Prüfmedikation | ||||
sepsh_14d | Septic Shock within first 14 days | integer | 8 | Septic Shock within first 14 days | 0, 1 | no, yes | Überleben und septischer Schock | ||||
ss_cens | Septic Shock | integer | 8 | Septic Shock | 0, 1 | no, yes | Überleben und septischer Schock | ||||
sssd | Time to Septic Shock [d] | d | integer | 6 | Time to Septic Shock [d] | Überleben und septischer Schock | |||||
eossd | Study Day of EOS | integer | 4 | Study Day of EOS | End of Study | ||||||
f_ss14d | Septic Shock within 14 days evaluable | integer | 8 | Septic Shock within 14 days evaluable | 0, 1 | no, yes | Überleben und septischer Schock | ||||
secinf28 | Secondary Infection | integer | 8 | Secondary Infection | 0, 1 | no, yes | Follow up Tag 28 | ||||
wfail28 | Weaning Failure | integer | 8 | Weaning Failure | 0, 1 | no, yes | Follow up Tag 28 | ||||
mweak28 | Muscle Weakness | integer | 8 | Muscle Weakness | 0, 1 | no, yes | Follow up Tag 28 | ||||
mrc28anz | Frequency Assessability of MRC Score checked | integer | 4 | Frequency Assessability of MRC Score checked | Follow up Tag 28 | ||||||
mrc28erh | No of MRC Scores documented | integer | 4 | No of MRC Scores documented | Follow up Tag 28 | ||||||
gibl28 | Gastrointestinal Bleeding | integer | 24 | Gastrointestinal Bleeding | 0, 1 | no, yes | Follow up Tag 28 | ||||
bilmax_si | Total Bilirubin max. | umol/L | float | 8.2 | Total Bilirubin max. [µmol/l] | Routinelabor | |||||
harn_si | Ures max. | mmol/L | float | 8.2 | Ures max. [mmol/l] | Routinelabor | |||||
leukomin_si | Leukocytes min. | 10**9/L | float | 8.2 | Leukocytes min. [G/l] | Routinelabor | |||||
leukomax_si | Leukocytes max. | 10**9/L | float | 8.2 | Leukocytes max. [G/l] | Routinelabor | |||||
skmin_si | Serum Potassium min. | mmol/L | float | 8.2 | Serum Potassium min. [mmol/l] | Routinelabor | |||||
skmax_si | Serum Potassium max. | mmol/L | float | 8.2 | Serum Potassium max. [mmol/l] | Routinelabor | |||||
snamin_si | Serum Sodium min. | mmol/L | float | 8.2 | Serum Sodium min. [mmol/l] | Routinelabor | |||||
snamax_si | Serum Sodium max. | mmol/L | float | 8.2 | Serum Sodium max. [mmol/l] | Routinelabor | |||||
pfratio_si | paO_2/FiO_2-Ratio | mm[Hg] | float | 8.2 | paO_2/FiO_2-Ratio [mmHg] | Routinelabor | |||||
pao2_si | paO_2 | mm[Hg] | float | 8.2 | paO_2 [mmHg] | Routinelabor | |||||
paco2_si | paCO_2 | mm[Hg] | float | 8.2 | paCO_2 [mmHg] | Routinelabor | |||||
urin24_b | Urine output | mL/24h | float | 8.2 | Urine output (ml/24h) | Routinelabor | |||||
skreamax_si | Serum-Kreatinin, max | umol/L | float | 8.2 | Serum-Kreatinin, max [µmol/l] | Routinelabor | |||||
skreamin_si | Serum Creatinine, min | umol/L | float | 8.2 | Serum Creatinine, min [µmol/l] | Routinelabor | |||||
tpzmin_si | Thrombocytes, min | 10**9/L | float | 8.2 | Thrombocytes, min [G/l] | Routinelabor | |||||
lakmax_si | Lactate max | mmol/L | float | 8.2 | Lactate max [mmol/l] | Routinelabor | |||||
hbmin_si | Hemoglobin | mmol/L | float | 8.2 | Hemoglobin [mmol/l] | Routinelabor | |||||
bzmin_si | Glucose min | mmol/L | float | 8.2 | Glucose min [mmol/l] | Routinelabor | |||||
bzmax_si | Glucose max | mmol/L | float | 8.2 | Glucose max [mmol/l] | Routinelabor | |||||
crpmax_si | CRP | mg/L | float | 8.2 | CRP [mg/l] | Routinelabor | |||||
gcs | GCS | integer | 8 | GCS | Routinelabor | ||||||
saps | SAPS II (without imputation) | integer | 8 | SAPS II (without imputation) | Scores | ||||||
ce11 | liver insufficiency | integer | 8 | liver insufficiency | Nebendiagnosen und Immunsuppression | ||||||
ce12 | heart insufficiency HYHA IV | integer | 8 | heart insufficiency HYHA IV | Nebendiagnosen und Immunsuppression | ||||||
ce13 | severe lung disease | integer | 8 | severe lung disease | Nebendiagnosen und Immunsuppression | ||||||
ce14 | chronic renal insufficiency, chronic dialysis | integer | 8 | chronic renal insufficiency, chronic dialysis | Nebendiagnosen und Immunsuppression | ||||||
ce15 | Immuno compromised | integer | 8 | Immuno compromised | Nebendiagnosen und Immunsuppression | ||||||
aado2 | Alveolo-arterielle Suaerstoffdifferenz | float | 8.2 | Alveolo-arterielle Sauerstoffdifferenz | Patientendaten | ||||||
apache | APACHE II (without Imputation) | integer | 8 | APACHE II (without Imputation) | Scores | ||||||
adr | Epinephrine | integer | 8 | Epinephrine | 0, 1 | no, yes | Vasopressoren und Inotropika | ||||
adr_dsi | highest dose epinephrine | ug/kg/min | float | 8.2 | highest dose epinephrine [µg/kg/min] | Vasopressoren und Inotropika | |||||
noradr | Norepinephrine | integer | 8 | Norepinephrine | 0, 1 | no, yes | Vasopressoren und Inotropika | ||||
noradr_dsi | highest dose norepinephrine | ug/kg/min | float | 8.2 | highest dose norepinephrine [µg/kg/min] | Vasopressoren und Inotropika | |||||
dop | Dopamine | integer | 8 | Dopamine | 0, 1 | no, yes | Vasopressoren und Inotropika | ||||
dop_dsi | highest dose dopamine | ug/kg/min | float | 8.2 | highest dose dopamine [µg/kg/min] | Vasopressoren und Inotropika | |||||
dobu | Dobutamine | integer | 8 | Dobutamine | 0, 1 | no, yes | Vasopressoren und Inotropika | ||||
dobu_dsi | highest dose dobutamine | ug/kg/min | float | 8.2 | highest dose dobutamine [µg/kg/min] | Vasopressoren und Inotropika | |||||
vaso | Vasopressin | integer | 8 | Vasopressin | 0, 1 | no, yes | Vasopressoren und Inotropika | ||||
sofacir_b | SOFA Subscore circulation at Baseline | float | 8.2 | SOFA Subscore circulation at Baseline | Scores | ||||||
sofapul_b | SOFA Subscore pulmo at Baseline | float | 8.2 | SOFA Subscore pulmo at Baseline | Scores | ||||||
sofacoa_b | SOFA Subscore coagulation at Baseline | float | 8.2 | SOFA Subscore coagulation at Baseline | Scores | ||||||
sofaren_b | SOFA Subscore renal at Baseline | float | 8.2 | SOFA Subscore renal at Baseline | Scores | ||||||
sofahep_b | SOFA Subscore liver at Baseline | float | 8.2 | SOFA Subscore liver at Baseline | Scores | ||||||
sofacns_b | SOFA Subscore CNS at Baseline | float | 8.2 | SOFA Subscore CNS at Baseline | Scores | ||||||
sofa_b | SOFA-Score at Baseline | float | 8.2 | SOFA-Score at Baseline | Scores | ||||||
hypna | Hypernatremia | integer | 8 | Hypernatremia | 0, 1 | no, yes | Adverse Events | ||||
hypnaut | Hypernatremia under IMP | integer | 8 | Hypernatremia under IMP | 0, 1 | no, yes | Adverse Events | ||||
mnamax | mean max Sodium | mmol/L | float | 8.2 | mean max Sodium [mmol/l] | Adverse Events | |||||
mnamaxut | mean max Sodium under IMP | mmol/L | float | 8.2 | mean max Sodium [mmol/l] under IMP | Adverse Events | |||||
hypgl | Hyperglycemia | integer | 8 | Hyperglycemia | 0, 1 | no, yes | Adverse Events | ||||
hypglut | Hyperglycemia under IMP | integer | 8 | Hyperglycemia under IMP | 0, 1 | no, yes | Adverse Events | ||||
mglmax | mean max Glucose | mg/dL | float | 8.2 | mean max Glucose [mg/dl] | Adverse Events | |||||
mglmaxut | mean max Glucose under IMP | mg/dL | float | 8.2 | mean max Glucose [mg/dl] under IMP | Adverse Events | |||||
lits | ICU length of stay | d | integer | 4 | ICU length of stay [d] | Liegedauer | |||||
lkh | hospital length of stay | d | integer | 4 | hospital length of stay [d] | Liegedauer | |||||
death_its | ICU Mortality | integer | 8 | ICU Mortality | 0, 1 | Survivor, Non-Survivor | Überleben und septischer Schock | ||||
death_kh | Hospital Mortality | integer | 8 | Hospital Mortality | 0, 1 | Survivor, Non-Survivor | Überleben und septischer Schock | ||||
ventd_eos | Days with ventilation until EOS | d | integer | 4 | Days with ventilation until EOS | End of Study | |||||
ventd_28d | Days with mech ventilation until D28 (on ICU) | d | integer | 4 | Days with mech ventilation until D28 (on ICU) | Follow up Tag 28 | |||||
ventd_its | Days with mech ventilation until ICU discharge | d | integer | 4 | Days with mech ventilation until ICU discharge | Follow up ITS-Entlassung | |||||
mb_its | Patients with mech ventilation until ICU discharge | integer | 8 | Patients with mech ventilation until ICU discharge | 0, 1 | no, yes | Follow up ITS-Entlassung | ||||
mb_28d | Patients with mech ventilation until day 28 | integer | 8 | Patients with mech ventilation until day 28 | 0, 1 | no, yes | Follow up Tag 28 | ||||
rrtd_eos | Days with RRT until EOS | d | integer | 4 | Days with RRT until EOS | End of Study | |||||
rrtfd_eos | Days without RRT until EOS | d | integer | 4 | Days without RRT until EOS | End of Study | |||||
f_nt_its | RRT evaluable | integer | 8 | RRT evaluable | 0, 1 | no, yes | Follow up ITS-Entlassung | ||||
rrtd_28d | Days with RRT until D28 (on ICU) | d | integer | 4 | Days with RRT until D28 (on ICU) | Follow up Tag 28 | |||||
rrtd_its | Days with RRT until ICU discharge | d | integer | 4 | Days with RRT until ICU discharge | Follow up ITS-Entlassung | |||||
rrt_its | Patients with RRT until ICU discharge | integer | 8 | Patients with RRT until ICU discharge | 0, 1 | no, yes | Follow up ITS-Entlassung | ||||
rrt_28d | Patients with RRT until day 28 | integer | 8 | Patients with RRT until day 28 | 0, 1 | no, yes | Follow up Tag 28 | ||||
dreasoth | other reason for death, free text | string | 600 | other reason for death, free text | Überleben und septischer Schock | ||||||
sepdeath | Sepsis related death | integer | 8 | Sepsis related death | 0, 1 | no, yes | Überleben und septischer Schock | ||||
sepdsd | Time to sepsis related death [days] | d | integer | 4 | Time to sepsis related death [days] | Überleben und septischer Schock | |||||
ss_death_cens | Septic Shock or Death | integer | 8 | Septic Shock or Death | 0, 1 | no, yes | Überleben und septischer Schock | ||||
ss_death_sd | Time to septic shock or death | integer | 5 | Time to septic shock or death | Überleben und septischer Schock | ||||||
ss_death_cens_14d | Septic Shock or Death within 14 days after rando | integer | 8 | Septic Shock or Death within 14 days after rando | 0, 1 | no, yes | Überleben und septischer Schock | ||||
ss_death_sd_14d | Time to septic shock or death | integer | 5 | Time to septic shock or death | Überleben und septischer Schock | ||||||
msofa_14d | meanSOFA until day 14 | float | 8.2 | meanSOFA until day 14 | Scores | ||||||
pxxxbb4d | any pathogen proven | integer | 8 | any pathogen proven | 0, 1 | no, yes | Patientendaten | ||||
hypna_150 | Hypernatremia (Cut Off 150 mmol/L) | integer | 8 | Hypernatremia (Cut Off 150 mmol/L) | 0, 1 | no, yes | Adverse Events | ||||
hypnaut_150 | Hypernatremia under IMP (Cut Off 150 mmol/L) | integer | 8 | Hypernatremia under IMP (Cut Off 150 mmol/L) | 0, 1 | no, yes | Adverse Events | ||||
second_inf | secondary Infection | integer | 8 | secondary Infection | 0, 1 | nein, ja | Adverse Events | ||||
gast_bleed | gastrointestinal Bleeding | integer | 8 | gastrointestinal Bleeding | 0, 1 | nein, ja | Adverse Events | ||||
resp_Event | Respiratory Event | integer | 8 | Respiratory Event | 0, 1 | nein, ja | Adverse Events | ||||
card_Event | Cardiovascular Event | integer | 8 | Cardiovascular Event | 0, 1 | nein, ja | Adverse Events | ||||
gast_Event | Gastrointestinal Event | integer | 8 | Gastrointestinal Event | 0, 1 | nein, ja | Adverse Events | ||||
cns_Event | CNS Event | integer | 8 | CNS Event | 0, 1 | nein, ja | Adverse Events |
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Metavariable | Value | Comment | |||||||
ODM_FileOID | HYPRESS.xml | A unique identifier for this file. | |||||||
ODM_Description | Information that will help the receiver interpret the document correctly. | ||||||||
ODM_ProtocolName | HYPRESS | This is the sponsor's internal name for the protocol. Defaults to StudyName. | |||||||
ODM_StudyDescription | HYPRESS | This is a free-text description of the study. Defaults to StudyName. | |||||||
ODM_StudyName | HYPRESS | This is a short external name for the study, is also used as OID | |||||||
ODM_StudyEventMandatory | Yes | Indicates that the clinical data for the containing MetaDataVersion would be incomplete without an instance of this type of Study Event | |||||||
ODM_StudyEventName | Event | Unique Name, is also used as OID. Defaults to 'Event'. | |||||||
ODM_StudyEventOrderNumber | 1 | ||||||||
ODM_StudyEventRepeatKey | empty if non repeating, <AUTOMATIC> for automatic counter otherwise Variable Reference (Variable.<Name>) | ||||||||
ODM_MetaDataVersionName | Name of Metadata version | ||||||||
ODM_MetaDataVersionOID | v1.0.0 | Metadata version ID. | |||||||
ODM_FormMandatory | Yes | Indicates that the clinical data for an instance of the containing study event would be incomplete without an instance of this type of form | |||||||
ODM_FormName | Form | Unique Name, is also used as OID. Defaults to 'Form'. | |||||||
ODM_FormRepeatKey | empty if non repeating, <AUTOMATIC> for automatic counter otherwise Variable Reference (Variable.<Name>) | ||||||||
ODM_ItemGroupMandatory | Yes | Indicates that the clinical data for an instance of the containing form would be incomplete without an instance of this type of item group | |||||||
ODM_ItemGroupRepeatKey | empty if non repeating, <AUTOMATIC> for automatic counter otherwise Variable Reference (Variable.<Name>) | ||||||||
ODM_ItemMandatory | Yes | Indicates that the clinical data for an instance of the containing item group would be incomplete without an instance of this type of item. | |||||||
Source_CSV_Charset | ISO-8859-1 | Data source file encoding. | |||||||
Source_CSV_Delimiter | ; | Data source file delimiter. | |||||||
Source_CSV_Header | Yes | Data source first row contains header. | |||||||
Source_CSV_Quote | " | Data is enclosed in | |||||||
ODM_AsOfDateTime | 2019-02-12T08:42:18 | ||||||||
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DO NOT CHANGE THIS SHEET | |||||||||
DataType | date | datetime | float | integer | partialDate | text | time | ||
YesNo | Yes | No | |||||||
Source_CSV_Charset | ISO_8859_1 | UTF-8 | |||||||
Source_CSV_Delimiter | \t | , | ; | ||||||
STDM | AGE | SEX | STUDYID | ARMCD | VISITNUM | BRTHDTC | SVSTDTC | SVENDTC | SUBJID |