Individualized Multiplex Pathophysiological Treatment of Severe Acute Infections (IMPACT)

Conditions

Severe acute infection

Brief summary

Days alive and out of hospital at 14 days post-randomization (DAOH-14)

Detailed description

Number of participants with one or more serious adverse event within 14 days of randomization, Days alive and out of hospital at 30 days post-randomization, All-cause mortality at 14, 30 and 180 days after inclusion, ICU admission within 14 and 30 days of randomization, Hospital length of stay within 14 and 30 days of admission, Health related quality-of-life at 180 days post-randomization (EQ-5D-5L), Duration of antibiotic therapy within 14 and 30 days of randomization, Escalation of antibiotic therapy within 14 and 30 days of randomization, Days requiring high-flow nasal oxygen therapy, continuous positive airway pressure or non-invasive ventilation within 30 days of randomization, Endotracheal intubation for hypoxia within 30 days of randomization, Initiation of vasoactive medication within 30 days of randomization, Number of participants with elevation of any parameter of liver dysfunction within 30 days of randomization, Blood transfusion within 30 days of randomization, Hemoglobin <6.2 within 30 days of randomization

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGSolu-Cortef

DRUGpulver og solvens til injektionsvæske

DRUGopløsning

DRUGHydrokortison Orion 10 mg tabletter.

DRUGAcetylcystein SAD koncentrat til infusionsvæske

DRUGMonofer

DRUGinjektions- og infusionsvæske

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Days alive and out of hospital at 14 days post-randomization (DAOH-14)	—

Secondary

Measure	Time frame
Number of participants with one or more serious adverse event within 14 days of randomization, Days alive and out of hospital at 30 days post-randomization, All-cause mortality at 14, 30 and 180 days after inclusion, ICU admission within 14 and 30 days of randomization, Hospital length of stay within 14 and 30 days of admission, Health related quality-of-life at 180 days post-randomization (EQ-5D-5L), Duration of antibiotic therapy within 14 and 30 days of randomization, Escalation of antibiotic therapy within 14 and 30 days of randomization, Days requiring high-flow nasal oxygen therapy, continuous positive airway pressure or non-invasive ventilation within 30 days of randomization, Endotracheal intubation for hypoxia within 30 days of randomization, Initiation of vasoactive medication within 30 days of randomization, Number of participants with elevation of any parameter of liver dysfunction within 30 days of randomization, Blood transfusion within 30 days of randomization, Hemoglobi	—

Measure

Time frame

Number of participants with one or more serious adverse event within 14 days of randomization, Days alive and out of hospital at 30 days post-randomization, All-cause mortality at 14, 30 and 180 days after inclusion, ICU admission within 14 and 30 days of randomization, Hospital length of stay within 14 and 30 days of admission, Health related quality-of-life at 180 days post-randomization (EQ-5D-5L), Duration of antibiotic therapy within 14 and 30 days of randomization, Escalation of antibiotic therapy within 14 and 30 days of randomization, Days requiring high-flow nasal oxygen therapy, continuous positive airway pressure or non-invasive ventilation within 30 days of randomization, Endotracheal intubation for hypoxia within 30 days of randomization, Initiation of vasoactive medication within 30 days of randomization, Number of participants with elevation of any parameter of liver dysfunction within 30 days of randomization, Blood transfusion within 30 days of randomization, Hemoglobi

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Countries

Denmark

Outcome results

None listed