NCT01690832

Brief Summary

Patients with acute coronary syndromes (ACS) are at increased risk for acute kidney injury (AKI) when they undergo urgent/emergency coronary angiography. The optimal medical treatment for preventing the occurrence of contrast induced - acute kidney injury is still controversial. Fenoldopam mesylate is a dopamine A1 receptor agonist that augments renal plasma flow that has reduced the risk of radiocontrast dye nephropathy in some (but not all) preliminary studies. Neutrophil gelatinase-associated lipocalin (NGAL) is a new biomarker predictive for AKI already shown to be useful for earlier diagnosis of contrast induced nephropathy. The primary objective of this study is to to test the hypothesis that fenoldopam, in addition to standard treatment, reduce the occurrence of contrast induced - acute kidney injury in patients with acute coronary syndrome (ACS) undergoing urgent/emergency coronary angiography and/or percutaneous coronary intervention.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for phase_4 coronary-artery-disease

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

1 active site

Status
unknown

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, 2012

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

September 19, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 24, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

September 24, 2012

Status Verified

September 1, 2012

Enrollment Period

1.2 years

First QC Date

September 19, 2012

Last Update Submit

September 19, 2012

Conditions

Coronary Artery Disease

Keywords

Contrast induced acute kidney injury

Outcome Measures

Primary Outcomes (1)

  • Contrast induced acute kidney injury

    Incidence of contrast induced acute kidney injury at 48 hour post-procedural control

    48 hour

Secondary Outcomes (1)

  • Markers of kidney injury

    48 hour

Study Arms (2)

standard saline infusion

ACTIVE COMPARATOR

standard i.v. 1 ml/kg/h saline infusion from 6 hours before the procedure to 12 hours after the procedure.

Drug: standard saline infusion

fenoldopam infusion

ACTIVE COMPARATOR

combination of i.v. 1 ml/kg/h saline infusion and fenoldopam administration (0.08 mcg/Kg/min) from 6 hours before the procedure to 12 hours after the procedure.

Drug: standard saline infusionDrug: fenoldopam infusion

Interventions

standard saline infusionDRUG

i.v. 1 ml/kg/h saline infusion from 6 hours before the procedure to 12 hours after the procedure

Also known as: saline infusion
fenoldopam infusionstandard saline infusion
fenoldopam infusionDRUG

combination of i.v. 1 ml/kg/h saline infusion and fenoldopam administration (0.08 mcg/Kg/min) from 6 hours before the procedure to 12 hours after the procedure

Also known as: fenoldopam administration (0.08 mcg/Kg/min)
fenoldopam infusion

Eligibility Criteria

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

You may qualify if:

  • Indication to urgent/emergency coronary angiography
  • Normal renal function (eGFR\> 60 ml/min/1.73 m2)
  • Moderate or high Mehran's risk score for CIN (\>11).
  • Able to understand and willing to sign the informed CF

You may not qualify if:

  • Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sapienza University

Rome, Lazio, 00166, Italy

Location

Related Publications (1)

  • 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

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Francesco Pelliccia, MD

    Sapienza University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 19, 2012

First Posted

September 24, 2012

Study Start

September 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2014

Last Updated

September 24, 2012

Record last verified: 2012-09

Locations

IT(1)