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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00747331
Other study ID # FenoldopamCPB
Secondary ID
Status Completed
Phase Phase 4
First received September 4, 2008
Last updated April 10, 2009
Start date September 2008
Est. completion date April 2009

Study information

Verified date April 2009
Source IRCCS Policlinico S. Donato
Contact n/a
Is FDA regulated No
Health authority Italy: National Institute of Health
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date April 2009
Est. primary completion date April 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Complex, combined cardiac operation

- Predicted CPB duration > 90 minutes

Exclusion Criteria:

- Age < 18 years

- No written informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

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
Placebo
Intravenous infusion (saline) Infused at the same rate (ml/h) as the experimental drug

Locations

Country Name City State
Italy IRCCS Policlinico S.Donato San donato Milanese Milan

Sponsors (1)

Lead Sponsor Collaborator
IRCCS Policlinico S. Donato

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Ranucci M, Soro G, Barzaghi N, Locatelli A, Giordano G, Vavassori A, Manzato A, Melchiorri C, Bove T, Juliano G, Uslenghi MF. Fenoldopam prophylaxis of postoperative acute renal failure in high-risk cardiac surgery patients. Ann Thorac Surg. 2004 Oct;78(4):1332-7; discussion 1337-8. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Peak blood lactate levels during CPB 3 hours No
Secondary Urine output during CPB 3 hours No
Secondary Peak blood lactate levels during the postoperative period 48 hours after the end of the operation No
Secondary Peak serum creatinine level during the postoperative period 48 hours after the end of the operation No
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