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Effect of Hydrocortison on Post-ischemic Flow-mediated Dilation and on Thenar Oxygen Saturation in Human Septic Shock.

NCT01817153 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2020-02-11

No results posted yet for this study

Summary

The main objectives of the study are 1)to examine the immediate (2 hours) and delayed (8 hours) effects of intravenous hydrocortison on macro and microvascular post-ischemic vasoreactivity, in septic shock adult patients; 2) to examine possible correlations between post-ischemic flow-mediated dilation (FMD) of the brachial artery (assessed by ultrasound imaging) and post-ischemic recovery slope of the thenar oxygen saturation (StO2) (assessed by near-infrared spectroscopy).

Conditions

  • Septic Shock
  • Adult

Interventions

DRUG

hydrocortison hemisuccinate

DRUG

placebo followed by hydrocortisone hemisuccinate

Sponsors & Collaborators

  • Centre Hospitalier Régional d'Orléans

    lead OTHER

Principal Investigators

  • Thierry Boulain, MD · Centre Hospitalier Régional d'Orléans, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-05
Primary Completion
2019-11-05
Completion
2019-11-05

Countries

  • France

Study Locations

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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 NCT01817153 on ClinicalTrials.gov