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OpenTrials
Completed

NCT Number: NCT00370643

Glucose Control in Open Heart Surgery

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

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Key information

Conditions

Hyperglycaemia During Perioperative Period Cardiovascular Diseases Glucose Metabolism Disorders Heart Diseases Heart Valve Diseases Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases Ventricular Dysfunction

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Heart Institute, Hospital of Clinics, São Paulo University Medical School

São Paulo, 05403-000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

human regular insulin

Drug

Primary outcomes

  1. Duration of intubation

  2. ICU length

  3. Blood transfusion

  4. Infection rate

  5. Renal dysfunction

  6. Neurological dysfunction

  7. Hospital length

  8. Mortality

Secondary outcomes

  1. Length of surgery

  2. Length of cardiopulmonary bypass

  3. Physical status

  4. EuroSCORE

  5. Parsonnet

  6. Canadian Multicenter index

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2002
Study completion
2004
First posted
Sep 1, 2006
Registry last updated
Feb 19, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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