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Clinical Trials/NCT00639912
NCT00639912CompletedPhase 4

Randomized Trial on the Effects of Hydration With Sodium Chloride Versus Sodium Bicarbonate to Prevent Contrast Induced Nephropathy, in Patients Undergoing Primary Coronary Interventions for Acute ST Elevation Myocardial Infarction.

Azienda USL Reggio Emilia - IRCCS5 sites in 1 country599 target enrollmentStarted: June 2007Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
599
Locations
5
Primary Endpoint
contrast induced nephropathy incidence

Study Overview

Brief Summary

The aim of the study is to test the efficacy of low versus high volume hydration and two different solutions (sodium chloride versus sodium bicarbonate) in preventing contrast induced nephropathy (CIN) in ST elevation myocardial infarction (STEMI) patients undergoing primary PCI.

Detailed Description

Contrast-induced nephropathy (CIN) is associated with increased morbidity and mortality after percutaneous coronary interventions (PCI). Patients with ST elevation myocardial infarction (STEMI) are at high risk for CIN because of hemodynamic instability of the patient, inability to prevent the phenomenon (hydration) and the possible exposure to high volume of contrast media. Recent reports have shown incidence of CIN up to 19% in this population and a related increase of in-hospital mortality.

Merten e coll. (JAMA 2004) reported that sodium bicarbonate infusion before and after contrast exposure in patients with chronic renal failure and without myocardial infarction (AMI) is more effective than sodium chloride in preventing CIN.

Up to date there is no evidence of any effective prophylactic measures in patients with STEMI undergoing primary PCI.

The aim of the study is to test the efficacy of low versus high volume hydration and the efficacy of two different solutions (sodium chloride versus sodium bicarbonate) in preventing CIN in STEMI patients undergoing primary PCI.

The infusion of the randomized solution will start just after randomization and after determination of baseline serum creatinine.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age > 18 years of years
  • Chest pain lasting at least 30 minutes, non responsive to nitrates, associated to ST elevation of at least 0.2 mV on surface ECG in two or more contiguous leads or to new left bundle branch block.
  • Informed consent

Exclusion Criteria

  • Chronic hemodialytic or peritoneal treatment
  • Coronary anatomy unsuitable for PCI
  • Need of emergency coronary artery by-pass grafting
  • Post-anoxic coma
  • Pregnancy

Arms & Interventions

A: low volume saline

Active Comparator

Solution of 154 mEq/L of sodium chloride. Rate of infusion: 1 ml/kg/hour for 12 hours after the procedure, starting in the Cath Lab.

Intervention: sodium chloride (Drug)

B: high volume saline

Active Comparator

Solution of 154 mEq/L of sodium chloride. Rate of infusion: 3 ml/Kg for 1 hour, followed by 1 ml/Kg/hour for 12 hours after the procedure, starting in the Cath lab.

Intervention: sodium chloride (Drug)

C: low volume sodium bicarbonate

Active Comparator

Solution of 154 mEq/L of sodium bicarbonate. Rate of infusion: 1 ml/Kg/hour for 12 hours after the procedure, starting in the Cath Lab.

Intervention: sodium bicarbonate (Drug)

D: high volume sodium bicarbonate

Active Comparator

Solution of 154 mEq/L of sodium bicarbonate. Rate of infusion: 3 ml/Kg for 1 hour, followed by 1 ml/Kg/hour for 12 hours after the procedure, starting in the Cath Lab.

Intervention: sodium bicarbonate (Drug)

Outcomes

Primary Outcomes

contrast induced nephropathy incidence

Time Frame: 24, 48 and 72 hours

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Azienda USL Reggio Emilia - IRCCS
Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (5)

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