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Fenoldopam and Splanchnic Perfusion During Cardiopulmonary Bypass

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ClinicalTrials.gov Identifier: NCT00747331
Recruitment Status : Completed
First Posted : September 5, 2008
Last Update Posted : April 13, 2009
Sponsor:
Information provided by:
IRCCS Policlinico S. Donato

Tracking Information
First Submitted Date  ICMJE September 4, 2008
First Posted Date  ICMJE September 5, 2008
Last Update Posted Date April 13, 2009
Study Start Date  ICMJE September 2008
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2009)
Peak blood lactate levels during CPB [ Time Frame: 3 hours ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 4, 2008)
Peak blood lactate levels during CPB [ Time Frame: Cardiopulmonary bypass time ]
Change History Complete list of historical versions of study NCT00747331 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2009)
  • Urine output during CPB [ Time Frame: 3 hours ]
  • Peak blood lactate levels during the postoperative period [ Time Frame: 48 hours after the end of the operation ]
  • Peak serum creatinine level during the postoperative period [ Time Frame: 48 hours after the end of the operation ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2008)
  • Urine output during CPB [ Time Frame: Cardiopulmonary bypass time ]
  • Peak blood lactate levels during the postoperative period [ Time Frame: 48 hours after the end of the operation ]
  • Peak serum creatinine level during the postoperative period [ Time Frame: 48 hours after he end of the operation ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fenoldopam and Splanchnic Perfusion During Cardiopulmonary Bypass
Official Title  ICMJE Fenoldopam Prophylaxis of Splanchnic Organs Underperfusion During Cardiopulmonary Bypass: a Randomized, Controlled Trial.
Brief Summary

Cardiopulmonary bypass (CPB) for cardiac operations may be accompanied by different patterns of visceral underperfusion. This could result in clinical patterns of lactic acidosis but in the most severe cases there is the risk for mesenteric infarction (0.2% of the cases). Renal function as well may be impaired due to a low oxygen delivery, and acute renal failure occurs in 1-2% of cases.

Fenoldopam mesilate is a selective splanchnic vasodilator when used at a dose < 0.1 mcg/kg/min.

The experimental hypothesis of this randomized, controlled trial (RCT) is that the use of fenoldopam may determine a better visceral perfusion during CPB.

Detailed Description

Randomized placebo-controlled double blinded study. Patients undergoing complex cardiac operations will be randomly allocated to the study or the control group.

All the patients will receive the standard of care of our Institution. Adequacy of CPB perfusion will be assessed using oxygen delivery calculation, lactate production, SvO2.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Cardiac Complications
  • Cardiopulmonary Bypass
Intervention  ICMJE
  • Drug: Fenoldopam mesilate
    Continuous intravenous infusion at 0.1 mcg/kg/min starting immediately before CPB and ending after 12 hours from the end of the operation
    Other Name: Corlopam
  • Drug: Placebo

    Intravenous infusion (saline)

    Infused at the same rate (ml/h) as the experimental drug

    Other Name: Saline
Study Arms  ICMJE
  • Experimental: A
    Intervention: Drug: Fenoldopam mesilate
  • Placebo Comparator: B
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: September 4, 2008)
80
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Complex, combined cardiac operation
  • Predicted CPB duration > 90 minutes

Exclusion Criteria:

  • Age < 18 years
  • No written informed consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00747331
Other Study ID Numbers  ICMJE FenoldopamCPB
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marco Ranucci, M.D., IRCCS Policlinico S.Donato
Study Sponsor  ICMJE IRCCS Policlinico S. Donato
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Marco Ranucci, M.D. IRCCS Policlinico S. Donato
PRS Account IRCCS Policlinico S. Donato
Verification Date April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP