NCT00445809

Brief Summary

Some patients who undergo cardiovascular surgery requiring cardiopulmonary bypass will develop a kidney injury following their surgery. The purpose of this study is to take a blood sample from patients before they have this type of surgery and then at nine time points after their surgery to test their plasma for a biomarker called NGAL and compare the NGAL levels to their creatinine levels. We hypothesize that NGAL is an earlier marker for kidney injury than creatinine.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
355

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2007

Typical duration for all trials

Geographic Reach
2 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2007

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 9, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

August 4, 2009

Status Verified

August 1, 2009

Enrollment Period

1.8 years

First QC Date

February 15, 2007

Last Update Submit

August 3, 2009

Conditions

Kidney Failure, Acute

Keywords

KidneyRenalCardiac Surgery with bypassCardiovascular surgery with cardiopulmonary bypass

Study Arms (2)

1

High Risk population for developing AKI during/after CABG surgery.

2

Medium Risk population for developing AKI during/after CABG surgery.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing CABG Surgery that are thought to have a risk of developing AKI during/after surgery.

You may qualify if:

  • Male or female scheduled for cardiovascular surgery (other than cardiac transplant) requiring cardiopulmonary bypass
  • years of age or older
  • i. The first approximately 150 to200 patients enrolled must have:
  • A Prediction of Acute Renal Failure Score ≥ 5 (see Reference 18 and Appendix B)
  • ii. The subsequent patients enrolled must have one or more of the following risk factors for post-bypass renal injury:
  • Age \> 70;
  • Pre-operative creatinine \> 1.4 mg/dL;
  • NYHA Class 3 or 4 heart failure or left ventricular ejection fraction \< 35%;
  • Insulin-dependent diabetes mellitus;
  • Undergoing cardiac valve surgery;
  • History of previous cardiac surgery.

You may not qualify if:

  • Age \< 18 years
  • Inability to obtain Informed Consent from patient or representative
  • Prisoners or other institutionalized or vulnerable individuals
  • Participation in an interventional clinical study within the previous 30 days
  • History of previous renal transplantation
  • Stage 5 chronic kidney disease (estimated GRF\<15 mL/min/1.73m2) (See Appendix C)
  • Known or suspected ongoing pre-operative acute renal failure due to any cause, including pre-renal, intrinsic renal or post-renal (obstructive) etiologies (as evidenced by increasing serum creatinines or oliguria pre-operatively)
  • Already receiving dialysis, in imminent need of dialysis or considered highly likely to need dialysis in the immediate post-operative period for fluid management
  • Any known or suspected renal ischemic insult(such as cardiac arrest)or nephrotoxic insult(other than intravascular contrast procedure) during the 48 hours prior to surgery
  • Known or suspected infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV)infection, hepatitis B virus (HBV) infection or other infectious hepatitis
  • Pre-operative hematocrit \<25%, recent blood transfusions have been administered to maintain hematocrit \>25% or any other contraindication to obtaining the study-specified blood samples
  • Undergoing cardiac transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

St. Anthony's Central Hospital

Denver, Colorado, United States

Location

George Washington University

Washington D.C., District of Columbia, United States

Location

Maine Medical Center

Portland, Maine, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, United States

Location

St. Peters Healthcare

Albany, New York, United States

Location

New York Methodist

Brooklyn, New York, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Location

University of Texas, Houston

Houston, Texas, United States

Location

University of British Columbia

Vancouver, British Columbia, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood Samples (3 10ml, 7 5ml) at ten timepoints over 5 days.

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Emil Paganini, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 15, 2007

First Posted

March 9, 2007

Study Start

February 1, 2007

Primary Completion

December 1, 2008

Study Completion

April 1, 2009

Last Updated

August 4, 2009

Record last verified: 2009-08

Locations

US(10)CA(1)