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Steroids and Post-resuscitation Infectious (Septic) Complications

NCT02408939 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 191

Last updated 2024-01-17

No results posted yet for this study

Summary

Postresuscitation disease is characterized by post-insult systemic inflammation, adrenal insufficiency, and circulatory failure. Such severe pathology may be associated with increased susceptibility to infectious complications and increased risk of death due to postresuscitation septic shock. The latter may be attenuated by stress-dose steroids. In this re-analysis of synthesized randomized clinical trial (RCT) data, the investigators will use individual patient data from two prior RCTs of in-hospital cardiac arrest (NCT00411879 \& NCT00729794), in order to determine the effect of stress-dose steroids on the severity of postresuscitation infectious complications, and more specifically, on the risk of septic shock-associated death.

Conditions

Interventions

DRUG

Stress-dose hydrocortisone

Patients with postresuscitation shock received stress-dose (300 mg) of hydrocortisone for 7 days maximum followed by gradual taper and discontinuation over 48 hours after either the resolution of their hemodynamic instability or day 7 of treatment.

Sponsors & Collaborators

  • University of Thessaly

    collaborator OTHER

  • University of Athens

    lead OTHER

Principal Investigators

  • Spyros D Mentzelopoulos, MD, PhD · University of Athens Medical School

  • Spyros D Mentzelopoulos, MD, PhD · University of Athens Medical School

  • Spyros G Zakynthinos, MD, PhD · University of Athens Medical School

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • France
  • Greece

Study Locations

More Related Trials

Entities

Diseases

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 NCT02408939 on ClinicalTrials.gov