Glucose Control in Open Heart Surgery - Full Text View

Sponsored by:	University of Sao Paulo
Information provided by:	University of Sao Paulo
ClinicalTrials.gov Identifier:	NCT00370643

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 I

MedlinePlus related topics: Heart Surgery Heart Valve Diseases Surgery

Drug Information available for: Insulin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Intensive Glucose Control Versus Conventional:Tendency Of Better Clinical Outcome In Open Heart Surgery

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:

van den Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P, Bouillon R. Intensive insulin therapy in the critically ill patients. N Engl J Med. 2001 Nov 8;345(19):1359-67.

Zerr KJ, Furnary AP, Grunkemeier GL, Bookin S, Kanhere V, Starr A. Glucose control lowers the risk of wound infection in diabetics after open heart operations. Ann Thorac Surg. 1997 Feb;63(2):356-61.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Chan RP, Galas FR, Hajjar LA, Bello CN, Piccioni MA, Auler JO Jr. Intensive perioperative glucose control does not improve outcomes of patients submitted to open-heart surgery: a randomized controlled trial. Clinics. 2009 Feb;64(1):51-60.

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

Keywords provided by University of Sao Paulo:

hyperglycaemia
open heart surgery
intensive care unit

Study placed in the following topic categories:

Ventricular Dysfunction
Hypoglycemic Agents
Metabolic Diseases
Heart Diseases
Hyperglycemia

Glucose Metabolism Disorders
Metabolic Disorder
Insulin
Heart Valve Diseases

Additional relevant MeSH terms:

Ventricular Dysfunction
Hypoglycemic Agents
Metabolic Diseases
Heart Diseases
Hyperglycemia
Physiological Effects of Drugs

Cardiovascular Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin
Heart Valve Diseases

ClinicalTrials.gov processed this record on May 07, 2009