Vasodilators and Anti-Oxidant Therapy in Early ATN

NCT00286403 | Withdrawn Phase 2 DMC

• 1 other identifier: MCAT-1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

Patients developing kidney failure after open heart surgery experience an abrupt decrease in blood flow to the kidney. The investigators hypothesize that administration of fenoldopam mesylate (a drug that increases blood flow to the kidney) to patients early in the course of their disease could reduce progression to dialysis-dependent acute renal failure. The investigators also hypothesize that restoring blood flow could induce additional injury to the kidney through the release of reactive oxygen species. Therefore, patients in this protocol will be randomized to receive a fenoldopam or the anti-oxidant MESNA. The investigators hypothesize that combination treatment with Fenoldopam and MESNA will decrease the incidence of death or dialysis at 21 days in patients with early post-operative acute renal failure.

Conditions

Acute Renal Failure

Keywords

Acute Tubular Necrosis; antioxidants; Fenoldopam

Outcome Measures

Primary Outcomes (1)

• Incidence of Death or Dialysis at 21 days

Secondary Outcomes (1)

• Peak serum Cr and Duration of ICU stay

Interventions

Fenoldopam Mesylate and/or MESNA DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Post-operative patients with serum creatinine (Cr) rising 0.3 mg/dl or more than 25% above admission levels within a single 24-hour period will be considered eligible.
• Central Venous Access: \[CVP \> 6 cm H2O without mechanical ventilation\] \[CVP \> 9 cm H2O with mechanical ventilation\]
• Mean arterial pressure \> 70 mm Hg receiving up to two vasopressors including:
• Nor-epinephrine (0.01-1.5g/kg/min)
• Phenylephrine (0.1-7.0g/kg/min
• Vasopressin (0.1-1.5 mU/kg/min)

You may not qualify if:

• Patients with APACHE scores greater than 30 (or felt by the principal investigators to be unlikely survive more than 24 hours).
• Patients requiring 3 or more presser agents to maintain a MAP of 70 mm Hg or greater.
• Patients on two vasopressors with a MAP \< 70 mm Hg will not be considered for enrollment
• Patient with baseline serum Cr \> 3.0 mg/dl
• Patients with known bacteremia and/or the Systemic Inflammatory Response Syndrome (SIRS)
• Patients ATN secondary to aminoglycosides or amphotericin B or equivalent anti-fungal drug
• Patients on chronic peritoneal or hemodialysis
• Patients receiving acute peritoneal or hemodialysis during current hospitalization
• Patients on dopamine infusion within the previous 12 hours
• Patients with known HIV seropositivity and past history of opportunistic infection
• Pregnant or lactating women
• Patients with history of uncontrolled atrial or ventricular cardiac arrhythmia
• Patients under the influence of alcohol or other drugs
• Patients enrolled in a previous investigational study within15 days of enrollment
• Patients with a known hypersensitivity to fenoldopam mesylate

Sponsors & Collaborators

• Southeast Renal Research Institute: lead
• Dialysis Clinic, Inc.: collaborator

Study Sites (2)

Chawala, M. MD

Washington D.C., District of Columbia, 20037, United States

Location

Mandeep Grewal

Chattanooga, Tennessee, 37403, United States

Location

Related Publications (2)

• Tumlin JA, Finkel KW, Murray PT, Samuels J, Cotsonis G, Shaw AD. Fenoldopam mesylate in early acute tubular necrosis: a randomized, double-blind, placebo-controlled clinical trial. Am J Kidney Dis. 2005 Jul;46(1):26-34. doi: 10.1053/j.ajkd.2005.04.002.

  PMID: 15983954 BACKGROUND

• Esezobor CI, Bhatt GC, Effa EE, Hodson EM. Fenoldopam for preventing and treating acute kidney injury. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD012905. doi: 10.1002/14651858.CD012905.pub2.

  PMID: 39607014 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury; Kidney Cortex Necrosis

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• James A Tumlin, MD

  Southeast Renal Research Institute

  PRINCIPAL INVESTIGATOR

• Micheal Kutner, Ph.D.

  Rollins School Public Health

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 1, 2006
• First Posted: February 3, 2006
• Study Start: August 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: March 28, 2016

Record last verified: 2016-03

Locations

US (2)