- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00557219
Fenoldopam and Ketanserin for Acute Kidney Failure Prevention After Cardiac Surgery
Influence of Fenoldopam and Ketanserin on Function and Kidney Injury Parameters in Patients With Increased Risk of Acute Kidney Failure After Cardiac Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Gdańsk, Poland, 80-211
- Department of Cardiac Anesthesiology, Medical University of Gdańsk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
Control group receiving placebo
|
continuous intravenous infusion of 2 mL/hour of 0.9% natrium chloride solution for 24 hours
|
EXPERIMENTAL: Ketanserin
patients receiving ketanserin infusion
|
continuous intravenous infusion 0.1 mg/kg/hour ketanserin for 24 hours
|
EXPERIMENTAL: Fenoldopam
patients receiving fenoldopam infusion
|
continuous intravenous infusion of 0.3 μg/kg/min fenoldopam for 24 hours
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
cystatin C and NGAL in serum
Time Frame: after 24 and 48 hours from treatment start
|
after 24 and 48 hours from treatment start
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
β2microglobulin in urine
Time Frame: after 24, 48 and 72 hours of treatment
|
after 24, 48 and 72 hours of treatment
|
creatinine increase in serum
Time Frame: after 24, 48 and 72 hours of treatment
|
after 24, 48 and 72 hours of treatment
|
frequency of renal replacement therapy
Time Frame: 7 days after surgery
|
7 days after surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Katarzyna Klajbor, MD, Dept. of Cardiac Anesthesiology, Medical University of Gdańsk
- Study Director: Romuald Lango, MD, PhD, Dept. of Cardiac Anesthesiology, Medical University of Gdańsk
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Kidney Diseases
- Urologic Diseases
- Renal Insufficiency
- Acute Kidney Injury
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Platelet Aggregation Inhibitors
- Serotonin Agents
- Dopamine Agonists
- Dopamine Agents
- Serotonin Antagonists
- Ketanserin
- Fenoldopam
Other Study ID Numbers
- AMG-NKEBN/225/2007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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