Study Results
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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COMPLETED
PHASE1
98 participants
INTERVENTIONAL
2002-10-31
2004-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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human regular insulin
Eligibility Criteria
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Inclusion Criteria
* open heart surgery with cardiopulmonary bypass
Exclusion Criteria
* reoperation
* use of inotropic support
* neurological dysfunction
* chronic pulmonary obstructive disease
* emergency or urgency
21 Years
ALL
No
Sponsors
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University of Sao Paulo
OTHER
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
Countries
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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.
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.
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.
Other Identifiers
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number: 637-02
Identifier Type: -
Identifier Source: org_study_id
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