search
Back to results

Hydration and Contrast-Induced Nephropathy in Primary Angioplasty

Primary Purpose

Contrast Induced Nephropathy

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
sodium bicarbonate solution
Isotonic saline
Placebo
Sponsored by
Ospedale Misericordia e Dolce
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Contrast Induced Nephropathy focused on measuring Contrast Induced Nephropathy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Ospedale Misericordia e Dolce

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

1

2

3

Arm Description

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

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

Placebo

Outcomes

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

Secondary Outcome Measures

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

Full Information

First Posted
October 9, 2008
Last Updated
May 6, 2012
Sponsor
Ospedale Misericordia e Dolce
search

1. Study Identification

Unique Protocol Identification Number
NCT00770614
Brief Title
Hydration and Contrast-Induced Nephropathy in Primary Angioplasty
Official Title
Hydration and Contrast-Induced Nephropathy in Primary Angioplasty. A Randomized, Placebo Controlled, Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ospedale Misericordia e Dolce

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contrast Induced Nephropathy
Keywords
Contrast Induced Nephropathy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
450 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
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
Arm Title
2
Arm Type
Active Comparator
Arm Description
Isotonic Saline (0.9% sodium chloride) 1 mL/kg/h for 12 hours after the procedure
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
sodium bicarbonate solution
Intervention Description
154 mEq/L in dextrose and H2O
Intervention Type
Drug
Intervention Name(s)
Isotonic saline
Intervention Description
0.9% sodium chloride
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
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
Time Frame
within 5 days after contrast exposure
Secondary Outcome Measure Information:
Title
Adverse clinical events within 1 month, including in-hospital death and need for dialysis or hemofiltration
Time Frame
1 month

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with Acute ST Elevation Myocardial Infarction submitted to Primary Intervention Exclusion Criteria: refusal to consent previous contrast exposure within 72 hours
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mauro Maioli, MD
Organizational Affiliation
Ospedale Misericordia e Dolce, Prato
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale Misericordia e Dolce
City
Prato
ZIP/Postal Code
59100
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

Hydration and Contrast-Induced Nephropathy in Primary Angioplasty

We'll reach out to this number within 24 hrs