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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Control group receiving placebo |
|
| Ketanserin | Experimental | patients receiving ketanserin infusion |
|
| Fenoldopam | Experimental | patients receiving fenoldopam infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fenoldopam (Corlopam) | Drug | continuous intravenous infusion of 0.3 μg/kg/min fenoldopam for 24 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| cystatin C and NGAL in serum | after 24 and 48 hours from treatment start |
| 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 |
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Inclusion Criteria:
cardiac surgery
at least one risk factor for acute renal failure:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katarzyna Klajbor, MD | Dept. of Cardiac Anesthesiology, Medical University of Gdańsk | Principal Investigator |
| Romuald Lango, MD, PhD | Dept. of Cardiac Anesthesiology, Medical University of Gdańsk | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiac Anesthesiology, Medical University of Gdańsk | Gdansk | 80-211 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39607014 | Derived | Esezobor CI, Bhatt GC, Effa EE, Hodson EM. Fenoldopam for preventing and treating acute kidney injury. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD012905. doi: 10.1002/14651858.CD012905.pub2. |
| Label | URL |
|---|---|
| home page of the Dept. of Cardiac Anesthesiology, MUG | View source |
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Upon reasonable request IPD can be made available to other researcher.
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D018818 | Fenoldopam |
| D007650 | Ketanserin |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| placebo | Drug | continuous intravenous infusion of 2 mL/hour of 0.9% natrium chloride solution for 24 hours |
|
| ketanserin (Sufrexal) | Drug | continuous intravenous infusion 0.1 mg/kg/hour ketanserin for 24 hours |
|
| 7 days after surgery |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D052999 | Quinazolinones |
| D011799 | Quinazolines |