Glucose Control in Open Heart Surgery

University of Sao Paulo

Status and phase: Completed; Phase 1

Conditions: Heart Valve Diseases; Ventricular Dysfunction; Hyperglycaemia During Perioperative Period

Treatments: Drug: human regular insulin

Study type: Interventional

Funder types: Other

Identifiers

NCT00370643

number: 637-02

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 21+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)