Fenoldopam and Ketanserin for Acute Kidney Failure Prevention After Cardiac Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Acute Renal Failure

Intervention / Treatment
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* Drug: fenoldopam (Corlopam)
* Drug: placebo
* Drug: ketanserin (Sufrexal)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: refused or none consent chronic renal failure with chronic renal replacement therapy chronic increase of serum creatinine > 2 mg/dl

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Control group receiving placebo | Drug: placebo<br>* continuous intravenous infusion of 2 mL/hour of 0.9% natrium chloride solution for 24 hours<br>|
| Experimental: Ketanserin<br>patients receiving ketanserin infusion | Drug: ketanserin (Sufrexal)<br>* continuous intravenous infusion 0.1 mg/kg/hour ketanserin for 24 hours<br>|
| Experimental: Fenoldopam<br>patients receiving fenoldopam infusion | Drug: fenoldopam (Corlopam)<br>* continuous intravenous infusion of 0.3 μg/kg/min fenoldopam for 24 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cystatin C and NGAL in serum |  | after 24 and 48 hours from treatment start | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac surgery, fenoldopam, ketanserin, renal replacement therapy