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