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Steroids and Microcirculation In Cardiac Surgery (SICS)

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ClinicalTrials.gov Identifier: NCT02798068
Recruitment Status : Recruiting
First Posted : June 14, 2016
Last Update Posted : August 8, 2017
Sponsor:
Collaborator:
Jean Paul Van Vooren
Information provided by (Responsible Party):
Erasme University Hospital

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.


Condition or disease Intervention/treatment Phase
C.Surgical Procedure Cardiac Drug: Solu-medrol or placebo administration Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of High-dose Corticosteroids on Microcirculation Alterations in Cardiac Surgery, by FMD (Flow Mediated vasoDilation), Near Infrared Spectrophotometry (NIRS) and Biological Analysis (Syndecan-1)
Study Start Date : May 2016
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017


Arm Intervention/treatment
Active Comparator: Solu - Medrol
Solu - Medrol (methylprednisolone sodium succinate) 500mg IV once single administration
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
Other Names:
  • Solu-medrol 500mg IV BE145214
  • Solu-medrol 500mg IV H02AB04
  • Solu-medrol 500mg IV SUB14562MIG
  • Solu-medrol 500mg IV 277S102F12

Placebo Comparator: Placebo
NaCl 0,9% 100ml IV once single administration
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
Other Names:
  • Solu-medrol 500mg IV BE145214
  • Solu-medrol 500mg IV H02AB04
  • Solu-medrol 500mg IV SUB14562MIG
  • Solu-medrol 500mg IV 277S102F12




Primary Outcome Measures :
  1. Flow Mediated Vasodilation change [ Time Frame: 3 measurements of 5 minutes each - vascular occlusion test once daily during 48h. ]
    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


Secondary Outcome Measures :
  1. StO2 variation change [ Time Frame: 4 measurements of 5 minutes each - vascular occlusion test test once daily during 48h ]
    Tissue oxygen saturation will be assessed by near - infrared spectroscopy (physiological parameter assesment based on spectrophotometry) during vascular occlusion test and after cuff release


Other Outcome Measures:
  1. Glycocalyx Biomarker analysis - Syndecan -1 plasmatic concentration assessment [ Time Frame: The first analysis will be performed once daily durin 72h ]

    C/ Syndecan - 1 concentration assessment: This molecule is closely linked to glycocalyx and is considered as the most predictive marker of its integrity.

    Many factors might cause lesions of this structure (inflammation, hyperglycemia, CBP, etc). Its destruction causes further an impairement of endothelial function (vasoconstriction et vasodilation), mediated principally by endothelial factors.

    Corticoids can be considered as the most effective molecule for glycocalyx protection.

    Yet we will analyze the plasmatic concentration variation of syndecan - 1 as a glycocalyx marker.

    Syndecan-1 analysis is performed on frozen plasma by ELISA technique, using specific antibodies (ELISA kit from Ray Biotech, Inc), this method has already been used in previous studies.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients eligible for cardiac surgery

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02798068


Contacts
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Contact: Katarina Halenarova, MD +32477283552 katarina.halenarova@gmail.com
Contact: Marco Pustetto, MD +32487590935 marco.pustetto@gmail.com

Locations
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Belgium
Hôpital Erasme Recruiting
Brussels, Belgium, 1070
Contact: Michele Geeraerts    +3225553324    Michele.Geeraerts@erasme.ulb.ac.be   
Contact: Fellemans Catherine    +3225553919    catherine.fellemans@erasme.ulb.ac.be   
Principal Investigator: Katarina Halenarova, MD         
Sponsors and Collaborators
Erasme University Hospital
Jean Paul Van Vooren
Investigators
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Study Chair: Luc Van Obbergh, Pr Anesthesia Department Hôpital Erasme

Publications:

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Responsible Party: Erasme University Hospital
ClinicalTrials.gov Identifier: NCT02798068     History of Changes
Other Study ID Numbers: P2016/017
First Posted: June 14, 2016    Key Record Dates
Last Update Posted: August 8, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Erasme University Hospital:
Steroids
Cardiac surgery
Endothelial dysfunction
Glycocalyx
Flow mediated vasodilation

Additional relevant MeSH terms:
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Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents