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Sponsored by: |
University of Sao Paulo |
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Information provided by: | University of Sao Paulo |
ClinicalTrials.gov Identifier: | NCT00370643 |
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
Condition | Intervention | Phase |
---|---|---|
Hyperglycaemia During Perioperative Period Heart Valve Diseases Ventricular Dysfunction |
Drug: human regular insulin |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Intensive Glucose Control Versus Conventional:Tendency Of Better Clinical Outcome In Open Heart Surgery |
Estimated Enrollment: | 98 |
Study Start Date: | October 2002 |
Estimated Study Completion Date: | November 2004 |
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.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Brazil | |
Heart Institute, Hospital of Clinics, São Paulo University Medical School | |
São Paulo, Brazil, 05403-000 |
Principal Investigator: | Jose O Costa Auler Junior, Professor | Heart instutute, Hospital of Clinics, São Paulo University Medical School |
Study Chair: | Raquel PC Chan | Heart Institute, Hospital of Clinics, São Paulo University Medical School |
Study ID Numbers: | number: 637-02 |
Study First Received: | August 30, 2006 |
Last Updated: | February 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00370643 History of Changes |
Health Authority: | Brazil: National Committee of Ethics in Research |
hyperglycaemia open heart surgery intensive care unit |
Ventricular Dysfunction Hypoglycemic Agents Metabolic Diseases Heart Diseases Hyperglycemia |
Glucose Metabolism Disorders Metabolic Disorder Insulin Heart Valve Diseases |
Ventricular Dysfunction Hypoglycemic Agents Metabolic Diseases Heart Diseases Hyperglycemia Physiological Effects of Drugs |
Cardiovascular Diseases Glucose Metabolism Disorders Pharmacologic Actions Insulin Heart Valve Diseases |