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Glucose Control in Open Heart Surgery

Primary Purpose

Hyperglycaemia During Perioperative Period, Heart Valve Diseases, Ventricular Dysfunction

Status

Completed

Phase

Phase 1

Locations

Brazil

Study Type

Interventional

Intervention

human regular insulin

About this trial

This is an interventional treatment trial for Hyperglycaemia During Perioperative Period focused on measuring hyperglycaemia, open heart surgery, intensive care unit

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Heart Institute, Hospital of Clinics, São Paulo University Medical School

Outcomes

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

Full Information

NCT ID

NCT00370643

First Posted

August 30, 2006

Last Updated

February 18, 2009

Sponsor

University of Sao Paulo

1. Study Identification

Unique Protocol Identification Number

NCT00370643

Brief Title

Glucose Control in Open Heart Surgery

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Completed

Study Start Date

October 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

November 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University of Sao Paulo

4. Oversight

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperglycaemia During Perioperative Period, Heart Valve Diseases, Ventricular Dysfunction

Keywords

hyperglycaemia, open heart surgery, intensive care unit

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

98 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

human regular insulin

Primary Outcome Measure Information:

Title

Duration of intubation

Title

ICU length

Title

Blood transfusion

Title

Infection rate

Title

Renal dysfunction

Title

Neurological dysfunction

Title

Hospital length

Title

Mortality

Secondary Outcome Measure Information:

Title

Length of surgery

Title

Length of cardiopulmonary bypass

Title

Physical status

Title

EuroSCORE

Title

Parsonnet

Title

Canadian Multicenter index

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jose O Costa Auler Junior, Professor

Organizational Affiliation

Heart instutute, Hospital of Clinics, São Paulo University Medical School

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Raquel PC Chan

Organizational Affiliation

Heart Institute, Hospital of Clinics, São Paulo University Medical School

Official's Role

Study Chair

Facility Information:

Facility Name

Heart Institute, Hospital of Clinics, São Paulo University Medical School

City

São Paulo

ZIP/Postal Code

05403-000

Country

Brazil

12. IPD Sharing Statement

Citations:

PubMed Identifier

11794168

Citation

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 critically ill patients. N Engl J Med. 2001 Nov 8;345(19):1359-67. doi: 10.1056/NEJMoa011300.

Results Reference

result

PubMed Identifier

9033300

Citation

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. doi: 10.1016/s0003-4975(96)01044-2.

Results Reference

result

PubMed Identifier

19142552

Citation

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 (Sao Paulo). 2009;64(1):51-60. doi: 10.1590/s1807-59322009000100010.

Results Reference

derived

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Glucose Control in Open Heart Surgery

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