Fenoldopam and Ketanserin for Acute Kidney Failure Prevention After Cardiac Surgery
NCT ID: NCT00557219
Last Updated: 2016-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE3
60 participants
INTERVENTIONAL
2008-04-30
2015-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
Control group receiving placebo
placebo
continuous intravenous infusion of 2 mL/hour of 0.9% natrium chloride solution for 24 hours
Ketanserin
patients receiving ketanserin infusion
ketanserin (Sufrexal)
continuous intravenous infusion 0.1 mg/kg/hour ketanserin for 24 hours
Fenoldopam
patients receiving fenoldopam infusion
fenoldopam (Corlopam)
continuous intravenous infusion of 0.3 μg/kg/min fenoldopam for 24 hours
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
fenoldopam (Corlopam)
continuous intravenous infusion of 0.3 μg/kg/min fenoldopam for 24 hours
placebo
continuous intravenous infusion of 2 mL/hour of 0.9% natrium chloride solution for 24 hours
ketanserin (Sufrexal)
continuous intravenous infusion 0.1 mg/kg/hour ketanserin for 24 hours
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* chronic renal failure with chronic renal replacement therapy
* chronic increase of serum creatinine \> 2 mg/dl
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medical University of Gdansk
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Maciej M. Kowalik
Dr.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Katarzyna Klajbor, MD
Role: PRINCIPAL_INVESTIGATOR
Dept. of Cardiac Anesthesiology, Medical University of Gdańsk
Romuald Lango, MD, PhD
Role: STUDY_DIRECTOR
Dept. of Cardiac Anesthesiology, Medical University of Gdańsk
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Cardiac Anesthesiology, Medical University of Gdańsk
Gdansk, , Poland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Related Links
Access external resources that provide additional context or updates about the study.
home page of the Dept. of Cardiac Anesthesiology, MUG
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AMG-NKEBN/225/2007
Identifier Type: -
Identifier Source: org_study_id