Hydration and Contrast-Induced Nephropathy in Primary Angioplasty

Sponsor

Ospedale Misericordia e Dolce (Other)

Overall Status

Completed

CT.gov ID

NCT00770614

Collaborator

(none)

450

Enrollment

Location

Arms

Duration (Months)

7.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Contrast Induced Nephropathy	Drug: sodium bicarbonate solution Drug: Isotonic saline Drug: Placebo	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

450 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Hydration and Contrast-Induced Nephropathy in Primary Angioplasty. A Randomized, Placebo Controlled, Trial.

Study Start Date :

Mar 1, 2004

Actual Primary Completion Date :

Jun 1, 2008

Actual Study Completion Date :

Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 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 154 mEq/L in dextrose and H2O
Active Comparator: 2 Isotonic Saline (0.9% sodium chloride) 1 mL/kg/h for 12 hours after the procedure	Drug: Isotonic saline 0.9% sodium chloride
Placebo Comparator: 3 Placebo	Drug: Placebo Placebo

Arm

Intervention/Treatment

Active Comparator: 1

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

154 mEq/L in dextrose and H2O

Active Comparator: 2

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

Drug: Isotonic saline

0.9% sodium chloride

Placebo Comparator: 3

Placebo

Drug: Placebo

Placebo

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

patients with Acute ST Elevation Myocardial Infarction submitted to Primary Intervention

Exclusion Criteria:

refusal to consent
previous contrast exposure within 72 hours

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ospedale Misericordia e Dolce	Prato		Italy	59100

Sponsors and Collaborators

Ospedale Misericordia e Dolce

Investigators

Principal Investigator: Mauro Maioli, MD, Ospedale Misericordia e Dolce, Prato

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mauro Maioli, MD, Ospedale Misericordia e Dolce

ClinicalTrials.gov Identifier:

NCT00770614

Other Study ID Numbers:

Prato0703
POCARD0703

First Posted:

Oct 10, 2008

Last Update Posted:

May 8, 2012

Last Verified:

May 1, 2012

Keywords provided by Mauro Maioli, MD, Ospedale Misericordia e Dolce

Contrast Induced Nephropathy

Additional relevant MeSH terms:

Kidney Diseases

Study Results

No Results Posted as of May 8, 2012