Steroids and Microcirculation In Cardiac Surgery

NCT02798068 | Terminated Phase 4 DMC

• 1 other identifier: P2016/017
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Steroids; Cardiac surgery; Endothelial dysfunction; Glycocalyx; Flow mediated vasodilation

Outcome Measures

Primary Outcomes (1)

• Flow Mediated Vasodilation change

  Arterial diameter variation and Doppler flow are measured at brachial artery during vascular occlusion test - viariation of diameter and doppler flow befor and after cuff release will be assessed

  3 measurements of 5 minutes each - vascular occlusion test once daily during 48h.

Secondary Outcomes (1)

• StO2 variation change

  4 measurements of 5 minutes each - vascular occlusion test test once daily during 48h

Other Outcomes (1)

• Glycocalyx Biomarker analysis - Syndecan -1 plasmatic concentration assessment

  The first analysis will be performed once daily durin 72h

Study Arms (2)

Solu - Medrol

ACTIVE COMPARATOR

Solu - Medrol (methylprednisolone sodium succinate) 500mg IV once single administration

Drug: Solu-medrol or placebo administration

Placebo

PLACEBO COMPARATOR

NaCl 0,9% 100ml IV once single administration

Drug: Solu-medrol or placebo administration

Interventions

Solu-medrol or placebo administration DRUG

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

Also known as: Solu-medrol 500mg IV BE145214, Solu-medrol 500mg IV H02AB04, Solu-medrol 500mg IV SUB14562MIG, Solu-medrol 500mg IV 277S102F12

Placebo; Solu - Medrol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients eligible for cardiac surgery

You may not qualify if:

• Age under 18years
• Allergy to corticoids
• Extreme emergency surgery
• Upper member vascular disease

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (1)

Hôpital Erasme

Brussels, 1070, Belgium

Location

Related Publications (27)

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MeSH Terms

Interventions

Methylprednisolone Hemisuccinate

Intervention Hierarchy (Ancestors)

Methylprednisolone; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Luc Van Obbergh, Pr

  Anesthesia Department Hôpital Erasme

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2016
• First Posted: June 14, 2016
• Study Start: May 1, 2016
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: July 1, 2024

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)