A Phase 3 interventional study of fenoldopam (Corlopam) and placebo in Acute Renal Failure, sponsored by Medical University of Gdansk. Terminated at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-15.
Sponsored by Medical University of Gdansk · Phase 3, Interventional, and Prevention
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.
1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.
This study's enrollment of 60 is above the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.
Browse Renal Insufficiency studies →Medical University of Gdansk is the lead sponsor of 130 studies on the registry; 46 are open to participants now.
Counted across the registry records on this site, refreshed daily.
at least one risk factor for acute renal failure:
Exclusion Criteria:
Control group receiving placebo
Drug: placebo
patients receiving ketanserin infusion
Drug: ketanserin (Sufrexal)
patients receiving fenoldopam infusion
Drug: fenoldopam (Corlopam)
continuous intravenous infusion of 0.3 μg/kg/min fenoldopam for 24 hours
continuous intravenous infusion of 2 mL/hour of 0.9% natrium chloride solution for 24 hours
continuous intravenous infusion 0.1 mg/kg/hour ketanserin for 24 hours
cystatin C and NGAL in serum
Time frame: after 24 and 48 hours from treatment start
β2microglobulin in urine
Time frame: after 24, 48 and 72 hours of treatment
creatinine increase in serum
Time frame: after 24, 48 and 72 hours of treatment
frequency of renal replacement therapy
Time frame: 7 days after surgery
Plan to share: Undecided — Upon reasonable request IPD can be made available to other researcher.
This study is terminated, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Medical University of Gdansk