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Fenoldopam and Splanchnic Perfusion During Cardiopulmonary Bypass

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00747331
Recruitment Status : Completed
First Posted : September 5, 2008
Last Update Posted : April 13, 2009
Information provided by:
IRCCS Policlinico S. Donato

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.

Condition or disease Intervention/treatment Phase
Cardiac Complications Cardiopulmonary Bypass Drug: Fenoldopam mesilate Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Fenoldopam Prophylaxis of Splanchnic Organs Underperfusion During Cardiopulmonary Bypass: a Randomized, Controlled Trial.
Study Start Date : September 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: A 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

Placebo Comparator: B Drug: Placebo

Intravenous infusion (saline)

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

Other Name: Saline

Primary Outcome Measures :
  1. Peak blood lactate levels during CPB [ Time Frame: 3 hours ]

Secondary Outcome Measures :
  1. Urine output during CPB [ Time Frame: 3 hours ]
  2. Peak blood lactate levels during the postoperative period [ Time Frame: 48 hours after the end of the operation ]
  3. Peak serum creatinine level during the postoperative period [ Time Frame: 48 hours after the end of the operation ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Age < 18 years
  • No written informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00747331

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IRCCS Policlinico S.Donato
San donato Milanese, Milan, Italy, 20097
Sponsors and Collaborators
IRCCS Policlinico S. Donato
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Study Director: Marco Ranucci, M.D. IRCCS Policlinico S. Donato
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Marco Ranucci, M.D., IRCCS Policlinico S.Donato Identifier: NCT00747331    
Other Study ID Numbers: FenoldopamCPB
First Posted: September 5, 2008    Key Record Dates
Last Update Posted: April 13, 2009
Last Verified: April 2009
Keywords provided by IRCCS Policlinico S. Donato:
Cardiopulmonary bypass
Lactic acidosis
Oxygen delivery
Acute renal failure
Additional relevant MeSH terms:
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Antihypertensive Agents
Vasodilator Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs