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Clinical Trials/NCT00370643
NCT00370643
Completed
Phase 1

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

University of Sao Paulo1 site in 1 country98 target enrollmentOctober 2002

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Hyperglycaemia During Perioperative Period
Sponsor
University of Sao Paulo
Enrollment
98
Locations
1
Primary Endpoint
Duration of intubation
Status
Completed
Last Updated
17 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2002
End Date
November 2004
Last Updated
17 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

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

Outcomes

Primary Outcomes

Duration of intubation

ICU length

Blood transfusion

Infection rate

Renal dysfunction

Neurological dysfunction

Hospital length

Mortality

Secondary Outcomes

  • Length of surgery
  • Length of cardiopulmonary bypass
  • Parsonnet
  • Canadian Multicenter index
  • Physical status
  • EuroSCORE

Study Sites (1)

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