CClinicalTrials.gg
Sign In
CompletedNCT00747331Updated Apr 13, 2009

Fenoldopam and Splanchnic Perfusion During Cardiopulmonary Bypass

A Phase 4 interventional study of Fenoldopam mesilate and Placebo in Cardiac Complications and Cardiopulmonary Bypass, sponsored by IRCCS Policlinico S. Donato. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-04-13.

Sponsored by IRCCS Policlinico S. Donato · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cardiac Complications
  • Cardiopulmonary Bypass

Keywords

  • Cardiopulmonary bypass
  • Lactic acidosis
  • Oxygen delivery
  • Acute renal failure
  • outcome
  • cardiac
  • surgery
03

In context

Lead sponsor

IRCCS Policlinico S. Donato is the lead sponsor of 101 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Age \< 18 years
  • No written informed consent
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    A

    Drug: Fenoldopam mesilate

  • Placebo comparator
    B

    Drug: Placebo

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

    Also known as: Corlopam

  • DrugPlacebo

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

    Also known as: Saline

06

What researchers measure

Primary outcomes

  1. Peak blood lactate levels during CPB

    Time frame: 3 hours

Secondary outcomes

  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

07

Study locations

1 site
  • IRCCS Policlinico S.Donato
    San donato Milanese, Milan 20097, Italy
08

References and documents

Publications

  • 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. doi: 10.1016/j.athoracsur.2004.02.065. PubMed 15464494 ↗
  • Ranucci M, De Benedetti D, Bianchini C, Castelvecchio S, Ballotta A, Frigiola A, Menicanti L. Effects of fenoldopam infusion in complex cardiac surgical operations: a prospective, randomized, double-blind, placebo-controlled study. Minerva Anestesiol. 2010 Apr;76(4):249-59. PubMed 20332738 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00747331
Lead sponsor
IRCCS Policlinico S. Donato
First posted
Sep 5, 2008
Start date
Sep 2008
Primary completion
Apr 2009
Completion
Apr 2009
Last update
Apr 13, 2009

Study contacts

Marco Ranucci, M.D.
study director · IRCCS Policlinico S. Donato

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

IRCCS Policlinico S. Donato

Start the discussion