Fenoldopam and Ketanserin for Acute Kidney Failure Prevention After Cardiac Surgery

NCT00557219 | Terminated Phase 3

• 1 other identifier: AMG-NKEBN/225/2007
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to compare the effect of fenoldopam and ketanserin on kidney function preservation in patients at high risk for renal failure after cardiac surgery. Acute, oliguric renal failure develops in up to 2% of patients undergoing cardiac surgery. Some of them require renal replacement therapy and despite that mortality in this group exceeds 30-60%. The investigators await that the use of fenoldopam and/or ketanserin may decrease the rate of severe renal failure.

Conditions

Acute Renal Failure

Keywords

cardiac surgery; fenoldopam; ketanserin; renal replacement therapy

Outcome Measures

Primary Outcomes (1)

• cystatin C and NGAL in serum

  after 24 and 48 hours from treatment start

Secondary Outcomes (3)

• β2microglobulin in urine

  after 24, 48 and 72 hours of treatment

• creatinine increase in serum

  after 24, 48 and 72 hours of treatment

• frequency of renal replacement therapy

  7 days after surgery

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Control group receiving placebo

Drug: placebo

Ketanserin

EXPERIMENTAL

patients receiving ketanserin infusion

Drug: ketanserin (Sufrexal)

Fenoldopam

EXPERIMENTAL

patients receiving fenoldopam infusion

Drug: fenoldopam (Corlopam)

Interventions

fenoldopam (Corlopam) DRUG

continuous intravenous infusion of 0.3 μg/kg/min fenoldopam for 24 hours

Fenoldopam

placebo DRUG

continuous intravenous infusion of 2 mL/hour of 0.9% natrium chloride solution for 24 hours

Placebo

ketanserin (Sufrexal) DRUG

continuous intravenous infusion 0.1 mg/kg/hour ketanserin for 24 hours

Ketanserin

Eligibility Criteria

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

You may qualify if:

• cardiac surgery
• at least one risk factor for acute renal failure:
• oliguria \< 0.5 ml/kg/hour for over 3 hours despite adequate blood volume and furosemide intravenously
• at least 60 mg furosemide/12 hours iv to maintain diuresis \> 1 ml/kg/hour

You may not qualify if:

• refused or none consent
• chronic renal failure with chronic renal replacement therapy
• chronic increase of serum creatinine \> 2 mg/dl

Sponsors & Collaborators

• Medical University of Gdansk: lead

Study Sites (1)

Department of Cardiac Anesthesiology, Medical University of Gdańsk

Gdansk, 80-211, Poland

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

Related Links

• home page of the Dept. of Cardiac Anesthesiology, MUG

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Fenoldopam; Ketanserin

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; Piperidines; Heterocyclic Compounds, 1-Ring; Quinazolinones; Quinazolines

Study Officials

• Katarzyna Klajbor, MD

  Dept. of Cardiac Anesthesiology, Medical University of Gdańsk

  PRINCIPAL INVESTIGATOR

• Romuald Lango, MD, PhD

  Dept. of Cardiac Anesthesiology, Medical University of Gdańsk

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: November 9, 2007
• First Posted: November 12, 2007
• Study Start: April 1, 2008
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: November 15, 2016

Record last verified: 2016-11

Locations

PL (1)