Glucose Control in Open Heart Surgery

Heart Valve Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00370643
• Other study ID #: number: 637-02
• Status: Completed
• Phase: Phase 1
• First received: August 30, 2006
• Last updated: February 18, 2009
• Start date: October 2002
• Est. completion date: November 2004

Study information

• Verified date: February 2009
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Valve Diseases
• Hyperglycaemia During Perioperative Period
• Hyperglycemia
• Ventricular Dysfunction

Intervention

Drug:
• human regular insulin

Locations

Country	Name	City	State
Brazil	Heart Institute, Hospital of Clinics, São Paulo University Medical School	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of intubation
Primary	ICU length
Primary	Blood transfusion
Primary	Infection rate
Primary	Renal dysfunction
Primary	Neurological dysfunction
Primary	Hospital length
Primary	Mortality
Secondary	Length of surgery
Secondary	Length of cardiopulmonary bypass
Secondary	Physical status
Secondary	EuroSCORE
Secondary	Parsonnet
Secondary	Canadian Multicenter index