NCT00747331

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2008

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 5, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

April 13, 2009

Status Verified

April 1, 2009

Enrollment Period

7 months

First QC Date

September 4, 2008

Last Update Submit

April 10, 2009

Conditions

Cardiac ComplicationsCardiopulmonary Bypass

Keywords

Cardiopulmonary bypassLactic acidosisOxygen deliveryAcute renal failureoutcomecardiacsurgery

Outcome Measures

Primary Outcomes (1)

  • Peak blood lactate levels during CPB

    3 hours

Secondary Outcomes (3)

  • Urine output during CPB

    3 hours

  • Peak blood lactate levels during the postoperative period

    48 hours after the end of the operation

  • Peak serum creatinine level during the postoperative period

    48 hours after the end of the operation

Study Arms (2)

A

EXPERIMENTAL
Drug: Fenoldopam mesilate

B

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Fenoldopam mesilateDRUG

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
A
PlaceboDRUG

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

Also known as: Saline
B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Age \< 18 years
  • No written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Policlinico S.Donato

San Donato Milanese, Milan, 20097, Italy

Location

Related Publications (3)

  • 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.

    PMID: 15464494BACKGROUND

  • Esezobor CI, Bhatt GC, Effa EE, Hodson EM. Fenoldopam for preventing and treating acute kidney injury. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD012905. doi: 10.1002/14651858.CD012905.pub2.

    PMID: 39607014DERIVED

  • 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.

    PMID: 20332738DERIVED

MeSH Terms

Conditions

Acidosis, LacticAcute Kidney Injury

Interventions

FenoldopamSodium Chloride

Condition Hierarchy (Ancestors)

AcidosisAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Marco Ranucci, M.D.

    IRCCS Policlinico S. Donato

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 4, 2008

First Posted

September 5, 2008

Study Start

September 1, 2008

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

April 13, 2009

Record last verified: 2009-04

Locations

IT(1)