MedTrace Logo

Steroids In caRdiac Surgery Trial (SIRS Trial)

NCT00427388 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 7507

Last updated 2014-08-04

No results posted yet for this study

Summary

SIRS trial is a large simple study in which high-risk patients undergoing cardiac surgery requiring the use of cardiopulmonary bypass (CPB) are randomly allocated to receive a pulse dose of Methylprednisolone or a matching placebo. Cardiopulmonary bypass initiates a systemic inflammatory response that facilitates development of post-operative complications. SIRS will confirm or deny the potential clinical benefits of suppressing this response through the use of systemic steroids. Specifically, does 250 mg of intravenous Methylprednisolone given twice, once on anesthetic induction and again on CPB initiation, result in improved early survival and less myocardial infarction in high-risk cardiac surgery patients requiring CPB?

Conditions

  • Cardiac Surgical Procedures
  • Cardiopulmonary Bypass
  • Systemic Inflammatory Response Syndrome

Interventions

DRUG

Methylprednisolone

Given by IV in 2 doses (250 mg each dose for a total of 500 mg)

OTHER

Placebo

Given in 2 IV doses (approximately 4 ml of 0.9% normal saline solution in each dose)

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Population Health Research Institute

    lead OTHER

Principal Investigators

  • Salim Yusuf, MD, DPhil · Pranic Healing Research Institute

  • Kevin Teoh, MD, MSc · McMaster University

  • Richard P Whitlock, MD, MSc · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2014-02-28
Completion
2014-08-31

Countries

  • Canada

Study Locations

More Related Trials

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 NCT00427388 on ClinicalTrials.gov