We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Glucose Control in Open Heart Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00370643
First Posted: September 1, 2006
Last Update Posted: February 19, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Sao Paulo
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): 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:
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
First Submitted: August 30, 2006
First Posted: September 1, 2006
Last Update Posted: February 19, 2009
Last Verified: February 2009

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

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