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Glucose Control in Open Heart Surgery

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00370643
First received: August 30, 2006
Last updated: February 18, 2009
Last verified: February 2009
History of Changes
  Purpose

The purpose of the study is to seek if there is difference to state glucose level in 80-120mg/dl or 200mg/dl in patients submitted to open heart surgery


Condition Intervention Phase
Hyperglycaemia During Perioperative Period
Heart Valve Diseases
Ventricular Dysfunction
 Drug: human regular insulin
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intensive Glucose Control Versus Conventional:Tendency Of Better Clinical Outcome In Open Heart Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Duration of intubation
  • ICU length
  • Blood transfusion
  • Infection rate
  • Renal dysfunction
  • Neurological dysfunction
  • Hospital length
  • Mortality

Secondary Outcome Measures:
  • Length of surgery
  • Length of cardiopulmonary bypass
  • Physical status
  • EuroSCORE
  • Parsonnet
  • Canadian Multicenter index

Estimated Enrollment: 98
Study Start Date: October 2002
Estimated Study Completion Date: November 2004
Detailed Description:

Hyperglycaemia in the intensive care unit and perioperative period has been accused to be one of the causes of worse clinical outcome. It is known that in open heart surgeries the glucose level must be set less than 200mg/dl, but new trials had set the glucose level lower than that: 140mg/dl in some studies and even lower (80-110mg/dl). Our trial had the intention to seek if there is difference setting glucose level in 2 different ones would modifies clinical outcome.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult more than 21 years old
  • open heart surgery with cardiopulmonary bypass

Exclusion Criteria:

  • renal dysfunction
  • reoperation
  • use of inotropic support
  • neurological dysfunction
  • chronic pulmonary obstructive disease
  • emergency or urgency
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00370643

Locations
Brazil
Heart Institute, Hospital of Clinics, São Paulo University Medical School
São Paulo, Brazil, 05403-000
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Jose O Costa Auler Junior, Professor Heart instutute, Hospital of Clinics, São Paulo University Medical School
Study Chair: Raquel PC Chan Heart Institute, Hospital of Clinics, São Paulo University Medical School
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00370643     History of Changes
Other Study ID Numbers: number: 637-02
Study First Received: August 30, 2006
Last Updated: February 18, 2009
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
hyperglycaemia
open heart surgery
intensive care unit

Additional relevant MeSH terms:
Heart Valve Diseases
Hyperglycemia
Ventricular Dysfunction
Heart Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
 Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013