NCT00606827

Brief Summary

Contrast-induced nephrophaty (CIN) accounts for more than 10% of hospital-acquired renal failure. Hydration with sodium bicarbonate is more protective than isotonic saline in animals. Limited data are available in humans. We compared the efficacy of sodium bicarbonate versus isotonic saline to prevent CIN in a large population of patients with renal dysfunction undergoing coronary angiography or intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2005

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

January 1, 2005

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 5, 2008

Completed
Last Updated

May 8, 2012

Status Verified

May 1, 2012

First QC Date

January 22, 2008

Last Update Submit

May 6, 2012

Conditions

Contrast-Induced Nephropathy

Keywords

Contrast-induced nephrophatyContrast mediaAngiographyCoronary percutaneous intervention

Study Arms (2)

A

EXPERIMENTAL

Bicarbonate

Drug: Sodium Bicarbonate

B

ACTIVE COMPARATOR

Saline

Drug: Isotonic Saline

Interventions

Sodium BicarbonateDRUG

Patients in the sodium bicarbonate group (154 mEq/L) received 3 ml/kg for 1 hour before contrast medium, followed by an infusion of 1 ml/kg/h for 6 hours after the procedure

A
Isotonic SalineDRUG

Patients assigned to the isotonic saline group received 1 ml/kg/h 0.9% sodium chloride for 12 hours before and after the procedure

B

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients with creatinine clearance \< 60 mL/min

You may not qualify if:

  • contrast medium administration within the previous 10 days
  • end-stage renal failure requiring dialysis
  • refusal to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale Misericordia e Dolce

Prato, Prato, 59100, Italy

Location

Related Publications (1)

  • Maioli M, Toso A, Leoncini M, Gallopin M, Tedeschi D, Micheletti C, Bellandi F. Sodium bicarbonate versus saline for the prevention of contrast-induced nephropathy in patients with renal dysfunction undergoing coronary angiography or intervention. J Am Coll Cardiol. 2008 Aug 19;52(8):599-604. doi: 10.1016/j.jacc.2008.05.026.

    PMID: 18702961DERIVED

MeSH Terms

Interventions

Sodium BicarbonateSodium Chloride

Intervention Hierarchy (Ancestors)

BicarbonatesCarbonatesCarbonic AcidCarbon Compounds, InorganicInorganic ChemicalsSodium CompoundsChloridesHydrochloric AcidChlorine Compounds

Study Officials

  • Mauro Maioli, MD

    Cardiology Unit - Prato

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 22, 2008

First Posted

February 5, 2008

Study Start

January 1, 2005

Study Completion

March 1, 2006

Last Updated

May 8, 2012

Record last verified: 2012-05

Locations

IT(1)