Fenoldopam and Splanchnic Perfusion During Cardiopulmonary Bypass

This study has been completed.
Sponsor:
Information provided by:
IRCCS Policlinico S. Donato
ClinicalTrials.gov Identifier:
NCT00747331
First received: September 4, 2008
Last updated: April 10, 2009
Last verified: April 2009
  Purpose

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 Intervention Phase
Cardiac Complications
Cardiopulmonary Bypass
Drug: Fenoldopam mesilate
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Fenoldopam Prophylaxis of Splanchnic Organs Underperfusion During Cardiopulmonary Bypass: a Randomized, Controlled Trial.

Resource links provided by NLM:


Further study details as provided by IRCCS Policlinico S. Donato:

Primary Outcome Measures:
  • Peak blood lactate levels during CPB [ Time Frame: 3 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Urine output during CPB [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
  • Peak blood lactate levels during the postoperative period [ Time Frame: 48 hours after the end of the operation ] [ Designated as safety issue: No ]
  • Peak serum creatinine level during the postoperative period [ Time Frame: 48 hours after the end of the operation ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: September 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Age < 18 years
  • No written informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00747331

Locations
Italy
IRCCS Policlinico S.Donato
San donato Milanese, Milan, Italy, 20097
Sponsors and Collaborators
IRCCS Policlinico S. Donato
Investigators
Study Director: Marco Ranucci, M.D. IRCCS Policlinico S. Donato
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marco Ranucci, M.D., IRCCS Policlinico S.Donato
ClinicalTrials.gov Identifier: NCT00747331     History of Changes
Other Study ID Numbers: FenoldopamCPB
Study First Received: September 4, 2008
Last Updated: April 10, 2009
Health Authority: Italy: National Institute of Health

Keywords provided by IRCCS Policlinico S. Donato:
Cardiopulmonary bypass
Lactic acidosis
Oxygen delivery
Acute renal failure
outcome
cardiac
surgery

Additional relevant MeSH terms:
Fenoldopam
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014