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Glucose Control in Open Heart Surgery

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00370643
Enrollment
98
Registered
2006-09-01
Start date
2002-10-31
Completion date
2004-11-30
Last updated
2009-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Valve Diseases, Hyperglycaemia During Perioperative Period, Ventricular Dysfunction

Keywords

hyperglycaemia, open heart surgery, intensive care unit

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.

Interventions

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Duration of intubation
ICU length
Blood transfusion
Infection rate
Renal dysfunction
Neurological dysfunction
Hospital length
Mortality

Secondary

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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026