NCT00770614

Brief Summary

The purpose of this study is to determine whether hydration with sodium bicarbonate is more effective than hydration with sodium chloride to prevent contrast induced nephropathy in patients undergoing Primary Coronary Intervention for Acute ST Elevation Myocardial Infarction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
450

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2004

Longer than P75 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

March 1, 2004

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 10, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

May 8, 2012

Status Verified

May 1, 2012

Enrollment Period

4.3 years

First QC Date

October 9, 2008

Last Update Submit

May 6, 2012

Conditions

Contrast Induced Nephropathy

Keywords

Contrast Induced Nephropathy

Outcome Measures

Primary Outcomes (1)

  • Absolute increase of at least 0.5 mg/dl from the baseline value in serum creatinine concentration or a relative increase ≥ 25% over baseline serum creatinine within 5 days after contrast agent administration

    within 5 days after contrast exposure

Secondary Outcomes (1)

  • Adverse clinical events within 1 month, including in-hospital death and need for dialysis or hemofiltration

    1 month

Study Arms (3)

1

ACTIVE COMPARATOR

Sodium Bicarbonate (154 mEq/L in dextrose and H2O) 3 mL/kg for 1 hour before contrast medium, followed by an infusion of 1 mL/kg/h for 12 hours after the procedure

Drug: sodium bicarbonate solution

2

ACTIVE COMPARATOR

Isotonic Saline (0.9% sodium chloride) 1 mL/kg/h for 12 hours after the procedure

Drug: Isotonic saline

3

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

sodium bicarbonate solutionDRUG

154 mEq/L in dextrose and H2O

1
Isotonic salineDRUG

0.9% sodium chloride

2
PlaceboDRUG

Placebo

3

Eligibility Criteria

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

You may qualify if:

  • patients with Acute ST Elevation Myocardial Infarction submitted to Primary Intervention

You may not qualify if:

  • refusal to consent
  • previous contrast exposure within 72 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale Misericordia e Dolce

Prato, Prato, 59100, Italy

Location

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Mauro Maioli, MD

    Ospedale Misericordia e Dolce, Prato

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 9, 2008

First Posted

October 10, 2008

Study Start

March 1, 2004

Primary Completion

June 1, 2008

Study Completion

December 1, 2008

Last Updated

May 8, 2012

Record last verified: 2012-05

Locations

IT(1)