Clinical trial NCT00370643: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hyperglycaemia During Perioperative Period
Heart Valve Diseases
Ventricular Dysfunction
Keywords: hyperglycaemia
open heart surgery
intensive care unit
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2006-09-01
Enrollment: 98
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Duration of intubation
measure: ICU length
measure: Blood transfusion
measure: Infection rate
measure: Renal dysfunction
measure: Neurological dysfunction
measure: Hospital length
measure: Mortality
Secondary outcomes:
measure: Length of surgery
measure: Length of cardiopulmonary bypass
measure: Physical status
measure: EuroSCORE
measure: Parsonnet
measure: Canadian Multicenter index
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Heart Institute, Hospital of Clinics, São Paulo University Medical School
Study officials:
affiliation: Heart instutute, Hospital of Clinics, São Paulo University Medical School
name: Jose O Costa Auler Junior, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Heart Institute, Hospital of Clinics, São Paulo University Medical School
name: Raquel PC Chan
role: STUDY_CHAIR
References:
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.
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.
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.