Effects of Hyperglycemia During Cardiopulmonary Bypass on Renal Function

This study is currently recruiting participants.

Verified by Weill Medical College of Cornell University, January 2010

First Received: November 28, 2006 Last Updated: January 4, 2010 History of Changes

Sponsor:	Weill Medical College of Cornell University
Information provided by:	Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:	NCT00404950

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:	Case-Only, Prospective
Official Title:	Effects of Hyperglycemia During Cardiopulmonary Bypass on Renal Function

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

U.S. FDA Resources

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

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

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 The platelet rich plasma will be withdrawn and one half of the volume immediately frozen for subsequent HPLC measurement of BH2 and BH4.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 2010

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:

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

Exclusion Criteria:

Patients with insulin dependent diabetes
Patients with preexisting renal dysfunction defined as Creatinine> 2 mg/dl
Patients in need of emergency cardiac procedures

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00404950

Contacts

Contact: Manuel Fontes, MD

212.746.0395

maf2029@med.cornell.edu

Locations

United States, New York
The New York Presbyterian Hospital - Weill Medical College of Cornell University	Recruiting
New York, New York, United States, 10021
Principal Investigator: Manuel Fontes, MD

Sponsors and Collaborators

Weill Medical College of Cornell University

Investigators

Principal Investigator:

Manuel Fontes, MD

Associate Professor

More Information

No publications provided

Responsible Party:	Weill Cornell Medical College ( Manuel Fontes, MD )
Study ID Numbers:	0408007400
Study First Received:	November 28, 2006
Last Updated:	January 4, 2010
ClinicalTrials.gov Identifier:	NCT00404950 History of Changes
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:

Hyperglycemia
Metabolic Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010