Measurement of Kidney Blood Flow and Oxygen Levels by MRI

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michael Rocco, Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT01318967
First received: March 18, 2011
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

The traditional measurement of renal blood flow in ml/min 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 estimate renal blood flow. The primary hypothesis is that renal blood flow as measured by PAH clearance is similar to renal blood flow as estimated by MRI. The measurements by PAH clearance and MRI are both performed on the same day.


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:


Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • Comparison of renal blood flow (RBF in ml/min) by PAH infusion versus estimation by MRI [ Time Frame: RBF measured over 1 hour by PAH and 30 minutes by MRI (day 1) ] [ Designated as safety issue: No ]
    Both measures are obtained on the same day and the results are compared.


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 ]

Enrollment: 10
Study Start Date: October 2010
Study Completion Date: June 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Furosemide
With and without furosemide
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: Michael Rocco, Professor Of Internal Medicine/Nephrology, Wake Forest School of Medicine
ClinicalTrials.gov Identifier: NCT01318967     History of Changes
Other Study ID Numbers: 0537GCRC
Study First Received: March 18, 2011
Last Updated: May 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
Renal blood flow
Regional renal blood flow
MRI

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

ClinicalTrials.gov processed this record on September 18, 2014