Fenoldopam and Ketanserin for Acute Kidney Failure Prevention After Cardiac Surgery

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00557219

Enrollment

Registered

2007-11-12

Start date

2008-04-30

Completion date

2015-04-30

Last updated

2016-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Renal Failure

Keywords

cardiac surgery, fenoldopam, ketanserin, renal replacement therapy

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.

Detailed 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.

Interventions

DRUGfenoldopam (Corlopam)

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

DRUGplacebo

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

DRUGketanserin (Sufrexal)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
cystatin C and NGAL in serum	after 24 and 48 hours from treatment start

Secondary

Measure	Time frame
frequency of renal replacement therapy	7 days after surgery
β2microglobulin in urine	after 24, 48 and 72 hours of treatment
creatinine increase in serum	after 24, 48 and 72 hours of treatment

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026