Patients with severe sepsis MedDRA version: 16.1 Level: PT Classification code 10040047 Term: Sepsis System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: not applicable
Product Code: not applicable
Pharmaceutical Form: Powder and solvent for solution for infusion
CAS Number: 8000042979
Other descriptive name: HYDROCORTISONE HYDROGEN SUCCI
Sponsors
Charité Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must meet ALL inclusion criteria: 1. Informed consent from patient, legal representative, proxy, or independent medical consultant. 2. In women with child bearing potential an effective contraception with a failure rate 2 x above the normal upper range, and/or need for renal replacement therapy. c. Coagulation dysfunction: Platelets = 100.000/µl or more than 30 % decrease from baseline within 24 hours. Thrombocytopenia may not be due to haemorrhage or immunologically induced. d. Pulmonary dysfunction/hypoxemia: PaO2 = 75 mmHg [= 10 kPa] at room air or PaO2/FiO2 = 250 mmHg [= 33 kPa] with oxygen application. Hypoxemia may not be due to primary cardiac or pulmonary dysfunction (e.g. emphysema) e. Microcirculatory dysfunction: Lactate > 1.5 x above the normal upper range and/or base deficit = 5 mmol/l and/or metabolic acidosis with pH =65 years) yes F.1.3.1 Number of subjects for this age range 230
Exclusion criteria
Exclusion criteria: Patients will be excluded for ANY ONE of the following reasons: I. Sepsis-induced HYPOTENSION despite adequate volume replacement defined as a mean arterial pressure (MAP) 10 mg prednisolone equivalent per day for at least 5 days within the last 3 months). Topical or inhaled glucocorticoids are NO exclusion criteria, unless there is an indication for continued systemic glucocorticoid administration. IV. Other indications for systemic glucocorticoid therapy (e.g. asthma, COPD, anaphylaxis, autoimmune diseases) V. DNR-order VI. Moribund patients VII. Pregnancy (positive pregnancy test in women with child bearing potential) VIII. Breast feeding women IX. Age < 18 years X. Concomitant or previous (within the last 30 days) participation in an other interventional clinical trial XI. Relationship to the investigator (e.g. relatives, colleagues, staff)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Prevention of the development of septic shock in patients with severe sepsis;Secondary Objective: Mortality and survival, length of ICU and hospital stay, time until septic shock develops, organ dysfunctions, duration of mechanical ventilation and renal replacement therapy, incidence of side effects and adverse events (safety), adrenal function at baseline ;Primary end point(s): Septic shock ;Timepoint(s) of evaluation of this end point: 14 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 28-day mortality (proportion of patients who die within 28 days from any cause) • 90 and 180-day mortality • ICU-mortality • Hospital mortality • Time to death from any cause and sepsis-related death • Length of ICU stay • Length of hospital stay • Time to septic shock and/or death within 14 days • Frequency and duration of mechanical ventilation until ICU discharge • Frequency and duration of renal replacement until ICU discharge • Mean total SOFA (organ dysfunction) and mean SOFA sub-scores until ICU discharge but day 14 at maximum • Frequency of weaning failure until ICU-discharge • Frequency and severity of muscle weakness until ICU-discharge • Frequency of GI-bleeding within 28 days • Frequency of secondary infections within 28 days • Frequency of delirium until ICU-discharge • Blood sodium level and frequency of hypernatremia (> 155 mmol/l) within 14 days • Blood glucose level and frequency of hyperglycemia (> 150 mg/dl) within 14 days • Other AEs or SAEs within 28 days;Timepoint(s) of evaluation of this end point: see E.5.2 | — |
Countries
Germany
Contacts
Public ContactDidier Keh
Charité Universitaetsmedizin Berlin
Outcome results
None listed