Glucose Control in Open Heart Surgery

NCT ID: NCT00370643

Last Updated: 2009-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2004-11-30

Brief Summary

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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

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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.

Conditions

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Hyperglycaemia During Perioperative Period Heart Valve Diseases Ventricular Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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human regular insulin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Principal Investigators

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Jose O Costa Auler Junior, Professor

Role: PRINCIPAL_INVESTIGATOR

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

Raquel PC Chan

Role: STUDY_CHAIR

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

Locations

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

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type RESULT
PMID: 11794168 (View on PubMed)

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.

Reference Type RESULT
PMID: 9033300 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19142552 (View on PubMed)

Other Identifiers

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number: 637-02

Identifier Type: -

Identifier Source: org_study_id

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