Clinical trial NCT00557219: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Acute Renal Failure
Keywords: cardiac surgery
fenoldopam
ketanserin
renal replacement therapy
Lead sponsor: Medical University of Gdansk
Sponsor class: OTHER
First posted: 2007-11-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* cardiac surgery
* 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:

* refused or none consent
* chronic renal failure with chronic renal replacement therapy
* chronic increase of serum creatinine \> 2 mg/dl

Primary outcomes:
measure: cystatin C and NGAL in serum
timeFrame: after 24 and 48 hours from treatment start
Secondary outcomes:
measure: β2microglobulin in urine
timeFrame: after 24, 48 and 72 hours of treatment
measure: creatinine increase in serum
timeFrame: after 24, 48 and 72 hours of treatment
measure: frequency of renal replacement therapy
timeFrame: 7 days after surgery
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: Department of Cardiac Anesthesiology, Medical University of Gdańsk
Study officials:
affiliation: Dept. of Cardiac Anesthesiology, Medical University of Gdańsk
name: Katarzyna Klajbor, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. of Cardiac Anesthesiology, Medical University of Gdańsk
name: Romuald Lango, MD, PhD
role: STUDY_DIRECTOR
References: