Text Size

Measurement of Kidney Blood Flow and Oxygen Levels by MRI

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Wake Forest University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Wake Forest University
ClinicalTrials.gov Identifier:
NCT01318967
First received: March 18, 2011
Last updated: March 31, 2011
Last verified: March 2011
History of Changes
  Purpose

The traditional measurement of renal blood flow involves the collection of multiple blood and urine samples after an infusion of a drug called para-aminohippurate (PAH) is given. In this study, the investigators determine the ability of MRI to measure renal blood flow. The primary hypothesis is that renal blood flow as measured by PAH clearance is similar to renal blood flow as measured by MRI.


Condition Intervention
Chronic Kidney Disease
 Drug: Furosemide

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: MRI for the Non-invasive Determination of Renal Blood Flow and Renal Oxygenation

Resource links provided by NLM:

Drug Information available for: Furosemide
U.S. FDA Resources

Further study details as provided by Wake Forest University:

Primary Outcome Measures:
  • Comparison of renal blood flow (RBF) by PAH and MRI [ Time Frame: RBF measured over 1 hour by PAH and 30 minutes by MRI (day 1) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measurement of regional blood oxygenation by MRI [ Time Frame: One measure before and after furosemide (day 1) ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: October 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Furosemide
    Renal blood flow is measured before and after the administration of 20 mg of furosemide.
    Other Name: Lasix
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

In this study, the investigators will enroll 16 men and women aged ≥ 18 years with Stage II - V chronic kidney disease (CKD). In addition, the investigators will enroll 4 subjects with a glomerular filtration rate (GFR) of greater than 60 ml/min who do not have any evidence of CKD.

Exclusion Criteria:

This study excludes those not suitable for MRI or for the interventional pharmacologic procedures.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01318967

Contacts
Contact: Michael Rocco, MD 336-716-2097 mrocco@wfubmc.edu

Locations
United States, North Carolina
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Principal Investigator: Michael Rocco, MD            
Sponsors and Collaborators
Wake Forest University
Investigators
Principal Investigator: Michael Rocco, MD Wake Forest University
  More Information

No publications provided

Responsible Party: Michael Rocco, M.D., Wake Forest University School of Medicine
ClinicalTrials.gov Identifier: NCT01318967     History of Changes
Other Study ID Numbers: 0537GCRC
Study First Received: March 18, 2011
Last Updated: March 31, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest University:
Renal blood flow
Regional renal blood flow
MRI

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency
Furosemide
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013