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Effects of Hyperglycemia During Cardiopulmonary Bypass on Renal Function

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00404950
First received: November 28, 2006
Last updated: March 7, 2012
Last verified: March 2012
History of Changes
  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:

U.S. FDA Resources

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 The platelet rich plasma will be withdrawn and one half of the volume immediately frozen for subsequent HPLC measurement of BH2 and BH4.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.


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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00404950     History of Changes
Other Study ID Numbers: 0408007400
Study First Received: November 28, 2006
Last Updated: March 7, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Diabetes Mellitus
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013