Intra-Renal Therapy of Diuretic Unresponsive Acute Kidney Injury

NCT01073189 | Withdrawn Phase 4

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

Brief Summary

Randomized prospective trial of patients with diuretic unresponsive acute kidney injury where patients will receive standard supportive therapy with diuretics versus intra-renal delivery of the vasodilator fenoldopam mesylate. Patients with rising creatinine who fail to respond to bolus diuretics will be treated with a prolonged course of diuretics or undergo placement of a catheter within the renal arteries that allows for infusion of fenoldopam mesylate. The rational is that early delivery of a high dose vasodilator may reverse the decline of renal function in patients with severe acute kidney injury.

Conditions

Kidney Failures, Acute

Keywords

Acute kidney injury; Fenoldopam mesylate; Benephit catheter

Outcome Measures

Primary Outcomes (1)

• Peak creatinine at day 4 Renal replacement therapy at 8 days All-cause mortality at 21 days

  Day 4, Day 8 and Day 21

Secondary Outcomes (1)

• 24 hour urinary volume at 72 hours Time to > 2.0 liters/24 hours Time to serum Cr < 2.5 mg/dl All cause mortality at 90 and 180 days

  All cause mortality at 90 and 180 days

Study Arms (2)

Intra-Renal Fenoldopam

EXPERIMENTAL

Intra-Renal Fenoldopam: Patients randomized to this wing will undergo placement of Angiodynamics Benefit catheter and receive intra-renal infusion of fenoldopm mesylate

Drug: Intra-Renal Fenoldopam

Diuretic Control

ACTIVE COMPARATOR

Patients in the control group will be randomized to receive intra-venous diuretics as a comparator control

Drug: Furosemide

Interventions

Intra-Renal Fenoldopam DRUG

Placement of an intra-renal catheter for infusion of fenoldopam mesylate

Also known as: Angiodynamics Benefit Catheter, Fenoldopam mesylate

Intra-Renal Fenoldopam

Furosemide DRUG

Patients randomized to the Diuretic Control group will receive intravenous furosemide as an active control

Also known as: Lasix

Diuretic Control

Eligibility Criteria

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

You may qualify if:

• Any patient age 18 or over with a 1.0 mg/dl rise in serum Cr within 48 hours or a fall in urine output of less than 20 mls/min X 2 consecutive hours.
• AND one of the two following Options
• Failure to double urine output within two hours of a 1.5 mg/kg bolus Furosemide -OR-
• Failure to maintain a 50% increase in urine output for 4 consecutive hours following a single 1.5 mg/kg bolus of furosemide WITH an MD performed Urinalysis documenting the presence of 3 or more "muddy brown casts" per low powered field (LPF) or the presence of a "free renal tubular cells"

You may not qualify if:

• Patients with APACHE scores greater than 25 (or felt by the principle investigators not to survive more than 24 hours)
• Patients with a MAP \< 65 on two or more vasopressor or any patient requiring 3 or more presser agents (nor epinephrine, + epinephrine or vasopressin) to maintain a MAP of 65 mm Hg .
• Patients receiving acute or chronic peritoneal or hemodialysis during current hospitalization
• Patients receiving dopamine or fenoldopam infusion within the previous 24 hours
• Patients requiring hemodynamic support with an intra-aortic balloon pump
• Patients with known HIV seropositivity
• Pregnant or lactating women
• Patients actively receiving NSAIDS or COX-2 antagonists
• Patients with history of uncontrolled cardiac arrhythmia
• Patients who cannot give informed consent.
• Patients with a known hypersensitivity to fenoldopam mesylate
• Patients with known bleeding diathesis
• Patients known blockage to one or more renal arteries
• Patients with known condition that would increase the likelihood of vascular perforation, trauma, or dissection such as Marfan's syndrome, cystic medial necrosis, abdominal or thoracoabdominal aortic dissection, mycotic aneurysm, abdominal aneurysm, thoracoabdominal aneurysm, renal artery aneurysm, thoracic aneurysm involving the visceral region of the aorta, and severe calcification in the area of the renal arteries

Sponsors & Collaborators

• Southeast Renal Research Institute: lead

Study Sites (1)

Erlanger Medical Center

Chattanooga, Tennessee, 37403, United States

Location

Related Publications (1)

• 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

Interventions

Fenoldopam; Furosemide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds

Study Officials

• James A Tumlin, MD

  Southeast Renal Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 22, 2010
• First Posted: February 23, 2010
• Study Start: April 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: March 28, 2016

Record last verified: 2016-03

Locations

US (1)