Glucose Control in Open Heart Surgery

February 18, 2009 updated by: University of Sao Paulo

Intensive Glucose Control Versus Conventional:Tendency Of Better Clinical Outcome In Open Heart Surgery

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

98

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 05403-000
        • Heart Institute, Hospital of Clinics, São Paulo University Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Mortality
Blood transfusion
Renal dysfunction
Duration of intubation
ICU length
Infection rate
Neurological dysfunction
Hospital length

Secondary Outcome Measures

Outcome Measure
Length of surgery
Length of cardiopulmonary bypass
Physical status
EuroSCORE
Parsonnet
Canadian Multicenter index

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Study Completion

November 1, 2004

Study Registration Dates

First Submitted

August 30, 2006

First Submitted That Met QC Criteria

August 30, 2006

First Posted (Estimate)

September 1, 2006

Study Record Updates

Last Update Posted (Estimate)

February 19, 2009

Last Update Submitted That Met QC Criteria

February 18, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • number: 637-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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