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Supplemental Corticosteroids in Cirrhotic Hypotensive Patients With Suspicion of Sepsis

NCT02602210 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-01-22

No results posted yet for this study

Summary

The main goal of the study is to investigate the clinical relevance, efficacy and safety of treating hypotensive cirrhotic patients with suspicion of sepsis and on vasopressors with low-dose hydrocortisone in order to reverse hemodynamic instability and organ failure and to decrease mortality.

Conditions

Interventions

DRUG

Hydrocortisone

IV bolus of 100 mg hydrocortisone in 50ml NaCl 0.9% (sodium chloride); followed by continuous IV infusion of 200 mg hydrocortisone in 50 ml NaCl 0.9% at a rate of 2 ml/h until the start of day 4.Reduction of infusion rate with 0.5 ml/h/day.

DRUG

NaCL 0.9%

IV bolus of 50 ml NaCL 0.9%; followed by continuous IV infusion of NaCL 0.9%

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • Philippe Meersseman, MD · Universitaire Ziekenhuizen KU Leuven

  • Alexander Wilmer, MD, PhD · Universitaire Ziekenhuizen KU Leuven

  • Javier Fernandez, MD,PhD · Hosp Clinic, Barcelona, Spain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • Belgium
  • Czechia
  • Denmark
  • Germany
  • Italy
  • Spain
  • United Kingdom

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 NCT02602210 on ClinicalTrials.gov