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Fenoldopam and Splanchnic Perfusion During Cardiopulmonary Bypass

Fenoldopam Prophylaxis of Splanchnic Organs Underperfusion During Cardiopulmonary Bypass: a Randomized, Controlled Trial.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00747331
Enrollment
80
Registered
2008-09-05
Start date
2008-09-30
Completion date
2009-04-30
Last updated
2009-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Complications, Cardiopulmonary Bypass

Keywords

Cardiopulmonary bypass, Lactic acidosis, Oxygen delivery, Acute renal failure, outcome, cardiac, surgery

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.

Interventions

DRUGFenoldopam 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

DRUGPlacebo

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

Sponsors

IRCCS Policlinico S. Donato
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Complex, combined cardiac operation * Predicted CPB duration \> 90 minutes

Exclusion criteria

* Age \< 18 years * No written informed consent

Design outcomes

Primary

MeasureTime frame
Peak blood lactate levels during CPB3 hours

Secondary

MeasureTime frame
Urine output during CPB3 hours
Peak blood lactate levels during the postoperative period48 hours after the end of the operation
Peak serum creatinine level during the postoperative period48 hours after the end of the operation

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026