Steroids and Microcirculation In Cardiac Surgery

NCT02798068 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-07-01

No results posted yet for this study

Summary

Cardiac surgery is sometimes associated with organ dysfunction of variable severity (renal insufficiency, cognitive decline, arrhythmias, ARDS). The phenomenon responsible is an intense inflammatory reaction induced by cardiopulmonary bypass, leading to microcirculation alterations, specially in endothelial cell and its protective layer - glycocalyx. Endothelial dysfunction then reduces the reactivity of peripheral tissues to hypoxia, and is associated with bad prognosis.

High - dose corticoids administration at anesthesia induction in cardiac surgery could attenuate the intensity of this inflammatory reaction, and represents the current practice in our hospital. Nevertheless, this attitude is abandoned in numerous cardiac surgery centres.

Conditions

  • C.Surgical Procedure
  • Cardiac

Interventions

DRUG

Solu-medrol or placebo administration

patients will receive 500mg of methylprednisolone in 100ml NaCl 0,9% or placebo (100ml NaCl 0,9%) at anesthesia induction

Sponsors & Collaborators

  • Erasme University Hospital

    lead OTHER

Principal Investigators

  • Luc Van Obbergh, Pr · Anesthesia Department Hôpital Erasme

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2021-09-30
Completion
2021-09-30

Countries

  • Belgium

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 NCT02798068 on ClinicalTrials.gov