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Hydrocortisone for Prevention of Septic Shock

NCT00670254 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 380

Last updated 2013-09-27

No results posted yet for this study

Summary

Severe sepsis is a disease with a high mortality. Development of shock is a most serious complication and increases the risk of death considerably. Application of low dose hydrocortisone is currently recommended only in patients after severe septic shock has been established. Hydrocortisone therapy has a hemodynamic stabilizing effect and may reverse shock, however, the preventive application has not been investigated in a larger study. The study investigates whether low dose hydrocortisone prevents the development of shock in patients with severe sepsis. It is postulated that shock prevention may also affect morbidity and mortality.

Conditions

  • Severe Sepsis

Interventions

DRUG

Placebo

Application is identical to experimental arm

DRUG

Hydrocortisone

50 mg loading dose, continuous infusion of 200 mg/d for 5 d, 100 mg/d for 2d, 50 mg/d for 2 d, and 25 mg/d for 2 d.

Sponsors & Collaborators

  • German Federal Ministry of Education and Research

    collaborator OTHER_GOV

  • SepNet - Critical Care Trials Group

    collaborator OTHER

  • Coordination Centre for Clinical Trials Leipzig

    collaborator UNKNOWN

  • Charite University, Berlin, Germany

    lead OTHER

Principal Investigators

  • Konrad Reinhart, MD · University Hospital Jena; Dept. of Anesthesiology an Intensive Care Medicine

  • Didier Keh, MD · Charité Universitaetsmedizin Berlin, Dept. of Anesthsiology and Intensive Care Medicine

  • Frank M Brunkhorst, MD · University Hospital Jena, Dept. of Anesthesiology and Intensive Care Medicine

  • Markus Loeffler, MD · University Leipzig, Coordination Center of Clinical Studies (KKSL)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00670254 on ClinicalTrials.gov