Fenoldopam and Ketanserin for Acute Kidney Failure Prevention After Cardiac Surgery
Primary Purpose
Acute Renal Failure
Status
Terminated
Phase
Phase 3
Locations
Poland
Study Type
Interventional
Intervention
fenoldopam (Corlopam)
placebo
ketanserin (Sufrexal)
Sponsored by
About this trial
This is an interventional prevention trial for Acute Renal Failure focused on measuring cardiac surgery, fenoldopam, ketanserin, renal replacement therapy
Eligibility Criteria
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
Sites / Locations
- Department of Cardiac Anesthesiology, Medical University of Gdańsk
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo
Ketanserin
Fenoldopam
Arm Description
Control group receiving placebo
patients receiving ketanserin infusion
patients receiving fenoldopam infusion
Outcomes
Primary Outcome Measures
cystatin C and NGAL in serum
Secondary Outcome Measures
β2microglobulin in urine
creatinine increase in serum
frequency of renal replacement therapy
Full Information
NCT ID
NCT00557219
First Posted
November 9, 2007
Last Updated
November 14, 2016
Sponsor
Medical University of Gdansk
1. Study Identification
Unique Protocol Identification Number
NCT00557219
Brief Title
Fenoldopam and Ketanserin for Acute Kidney Failure Prevention After Cardiac Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Terminated
Why Stopped
Main cooperator finished cooperation
Study Start Date
April 2008 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Gdansk
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Renal Failure
Keywords
cardiac surgery, fenoldopam, ketanserin, renal replacement therapy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Control group receiving placebo
Arm Title
Ketanserin
Arm Type
Experimental
Arm Description
patients receiving ketanserin infusion
Arm Title
Fenoldopam
Arm Type
Experimental
Arm Description
patients receiving fenoldopam infusion
Intervention Type
Drug
Intervention Name(s)
fenoldopam (Corlopam)
Intervention Description
continuous intravenous infusion of 0.3 μg/kg/min fenoldopam for 24 hours
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
continuous intravenous infusion of 2 mL/hour of 0.9% natrium chloride solution for 24 hours
Intervention Type
Drug
Intervention Name(s)
ketanserin (Sufrexal)
Intervention Description
continuous intravenous infusion 0.1 mg/kg/hour ketanserin for 24 hours
Primary Outcome Measure Information:
Title
cystatin C and NGAL in serum
Time Frame
after 24 and 48 hours from treatment start
Secondary Outcome Measure Information:
Title
β2microglobulin in urine
Time Frame
after 24, 48 and 72 hours of treatment
Title
creatinine increase in serum
Time Frame
after 24, 48 and 72 hours of treatment
Title
frequency of renal replacement therapy
Time Frame
7 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katarzyna Klajbor, MD
Organizational Affiliation
Dept. of Cardiac Anesthesiology, Medical University of Gdańsk
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Romuald Lango, MD, PhD
Organizational Affiliation
Dept. of Cardiac Anesthesiology, Medical University of Gdańsk
Official's Role
Study Director
Facility Information:
Facility Name
Department of Cardiac Anesthesiology, Medical University of Gdańsk
City
Gdańsk
ZIP/Postal Code
80-211
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Upon reasonable request IPD can be made available to other researcher.
Links:
URL
http://www.informator.gumed.edu.pl/327
Description
home page of the Dept. of Cardiac Anesthesiology, MUG
Learn more about this trial
Fenoldopam and Ketanserin for Acute Kidney Failure Prevention After Cardiac Surgery
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