Fenoldopam and Ketanserin for Acute Kidney Failure Prevention After Cardiac Surgery

Acute Renal Failure Clinical Trial

Official title:

Influence of Fenoldopam and Ketanserin on Function and Kidney Injury Parameters in Patients With Increased Risk of Acute Kidney Failure After Cardiac Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00557219
• Other study ID #: AMG-NKEBN/225/2007
• Status: Terminated
• Phase: Phase 3
• First received: November 9, 2007
• Last updated: November 14, 2016
• Start date: April 2008
• Est. completion date: April 2015

Study information

• Verified date: November 2016
• Source: Medical University of Gdansk
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Science and Higher Education
• Study type: Interventional

Clinical Trial 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.

Description:

Informed, signed consent will be obtained from the patient before surgery. In patients with acute consciousness disorders, the consent will be obtained from a legal representative and confirmed by the local court - accordingly to Polish legacy.

Patients willing to participate into the study and fulfilling at least one of two inclusion criteria will be randomly assigned to one of the three study groups. The treatment will be applied for 24 hours.

Intention to treat analysis will include comparison for differences of continuous, homogeneous distributed data with use of parametric tests, parametric or inhomogeneous distributed data - with use of nonparametric tests. The treatment effect will be assessed by comparison of the odds ratios for primary and secondary outcomes between the groups.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• cardiac surgery

• at least one risk factor for acute renal failure:

1. oliguria < 0.5 ml/kg/hour for over 3 hours despite adequate blood volume and furosemide intravenously

2. at least 60 mg furosemide/12 hours iv to maintain diuresis > 1 ml/kg/hour

Exclusion Criteria:

• refused or none consent

• chronic renal failure with chronic renal replacement therapy

• chronic increase of serum creatinine > 2 mg/dl

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Renal Failure
• Renal Insufficiency

Intervention

Drug:
• fenoldopam (Corlopam)
continuous intravenous infusion of 0.3 µg/kg/min fenoldopam for 24 hours
• placebo
continuous intravenous infusion of 2 mL/hour of 0.9% natrium chloride solution for 24 hours
• ketanserin (Sufrexal)
continuous intravenous infusion 0.1 mg/kg/hour ketanserin for 24 hours

Locations

Country	Name	City	State
Poland	Department of Cardiac Anesthesiology, Medical University of Gdansk	Gdansk

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Gdansk

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cystatin C and NGAL in serum		after 24 and 48 hours from treatment start	Yes
Secondary	ß2microglobulin in urine		after 24, 48 and 72 hours of treatment	Yes
Secondary	creatinine increase in serum		after 24, 48 and 72 hours of treatment	Yes
Secondary	frequency of renal replacement therapy		7 days after surgery	Yes

External Links

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