A Pilot Study to Investigate Fenoldopam Usage in the Prevention of Postoperative Renal Dysfunction in Patients at a High Risk for Renal Impairment During Cariopulmonary Bypass for Cardiac Surgery

NCT00467181 | Completed Phase 2 DMC

• 1 other identifier: RP05009
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The Primary objective is to reduce the incidence of postoperative renal dysfunction in a high-risk subset of patients undergoing cardiac surgery on cardiopulmonary bypass with Fenolopam, a selective dopamine-1 receptor agonist. Perioperative renal function will be observed in 3 randomly selected groups of patients-Fenoldopam infusion at 0.03 cg/kg/min, Fenoldopam at 0.1 mcg/kg/min or placebo Secondary objective: will be to correlate Fenoldopam usage with postoperative clinical outcomes such as ICU stay, hospital stay, need for inotropes/vasopressors, need for diuretics, requirements for ECF at discharge, and overall perioperative cost reduction through decreased ICU and hospital length of stay.

Conditions

Cardiac Surgery With Cardiopulmonary Bypass

Keywords

cardiac surgery; renal dysfunction

Outcome Measures

Primary Outcomes (1)

• To evaluate postop renal dysfunction in patients undergoing cardiac surgery. Post-op creatinine, urine output, and progression to renal dysfunction will be observed. Renal dysfunction will be defined as an increase in

  During Stay

Secondary Outcomes (1)

• Length of ICU and hospital stay, ventilator requirements,need for diuretics, or perioperative inotropes/vasopressors, and need for discharge to extended care facilities.

  Length of stay

Interventions

Fenoldopam DRUG

Eligibility Criteria

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

You may qualify if:

• Patients undergoing CABG, CABG/valve operations must meet one of the following:
• Age greater than 70
• Preoperative (within one week) creatinine \> or = 1.3
• Insulin depenent diabetes
• NYHA CHF class 3 or 4
• Bypass time anticipated to be greater than 3 hours
• Redo coronary artery bypass grafting
• Low cardiac output states -need for inotropic agents or IABP preoperatively

You may not qualify if:

• Emergent operations
• Preopertive liver failure
• Preopertive acute or chronic dialysis dependence
• Known allergy to Fenoldopam
• Patients in whom usage of dopaminergic medications are contraindicated
• Age less than 30
• Caridac surgery without cardiopulmonary bypass
• Patients acively participating in other clinical trials
• Usage of dopaminergic medication

Sponsors & Collaborators

• Summa Health System: lead

Study Sites (1)

Summa Health System

Akron, Ohio, 44304, 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

Renal Insufficiency

Interventions

Fenoldopam

Condition Hierarchy (Ancestors)

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

Study Officials

• Marion Hochstetler, MD

  Summa Health System

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 26, 2007
• First Posted: April 27, 2007
• Study Start: January 1, 2005
• Primary Completion: April 1, 2006
• Study Completion: April 1, 2006
• Last Updated: January 30, 2008

Record last verified: 2007-04

Locations

US (1)