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Effects of Hyperglycemia During Cardiopulmonary Bypass on Renal Function

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00404950
First Posted: November 29, 2006
Last Update Posted: February 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Weill Medical College of Cornell University
  Purpose
To determine whether intraoperative hyperglycemia potentiates renal injury in the setting of cardiac surgery requiring cardiopulmonary bypass.

Condition
Hyperglycemia Diabetes

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effects of Hyperglycemia During Cardiopulmonary Bypass on Renal Function

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Biospecimen Retention:   Samples Without DNA
At the following times when plasma glucose will be measured, an additional 6 mL of blood will be drawn (from indwelling routine arterial line catheter) into EDTA tubes and immediately centrifuged: baseline following induction, once during cardiopulmonary bypass, at arrival in the intensive care unit, and the morning after surgery- totaling 24 mls of blood. The platelet rich plasma will be withdrawn and one half of the volume immediately frozen for subsequent HPLC measurement of BH2 and BH4. The remaining plasma will be subjected to progressive centrifugation steps in order to concentrate the platelet fraction that will then be suspended in buffer and frozen. VASP expression and phosphorylation will be determined by Western blot.

Enrollment: 200
Actual Study Start Date: July 2005
Study Completion Date: July 2012
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing on pump cardiopulmonary bypass for either myocardial revascularization (coronary artery bypass graft) or valvular surgery (valve repair or replacement)
Criteria

Inclusion Criteria:

  1. Male and female patients ≥ 50 years of age
  2. Patients undergoing on pump cardiopulmonary bypass for either myocardial revascularization (coronary artery bypass graft) or valvular surgery (valve repair or replacement)

Exclusion Criteria:

  1. Patients with insulin dependent diabetes
  2. Patients with preexisting renal dysfunction defined as Creatinine> 2 mg/dl
  3. Patients in need of emergency cardiac procedures
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00404950


Locations
United States, New York
The New York Presbyterian Hospital - Weill Medical College of Cornell University
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Paul Heerdt, MD, PhD Associate Professor
  More Information

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00404950     History of Changes
Other Study ID Numbers: 0408007400
First Submitted: November 28, 2006
First Posted: November 29, 2006
Last Update Posted: February 6, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Will not share

Keywords provided by Weill Medical College of Cornell University:
hyperglycemia
cardiopulmonary bypass
renal injury
diabetes

Additional relevant MeSH terms:
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases