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Hydration and Contrast-Induced Nephropathy in Primary Angioplasty

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00770614
First Posted: October 10, 2008
Last Update Posted: May 8, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mauro Maioli, Ospedale Misericordia e Dolce
  Purpose
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 Intervention Phase
Contrast Induced Nephropathy Drug: sodium bicarbonate solution Drug: Isotonic saline Drug: Placebo Phase 4

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Mauro Maioli, Ospedale Misericordia e Dolce:

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 [ Time Frame: 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 [ Time Frame: 1 month ]

Enrollment: 450
Study Start Date: March 2004
Study Completion Date: December 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00770614


Locations
Italy
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
  More Information

Responsible Party: Mauro Maioli, MD, Ospedale Misericordia e Dolce
ClinicalTrials.gov Identifier: NCT00770614     History of Changes
Other Study ID Numbers: Prato0703
POCARD0703
First Submitted: October 9, 2008
First Posted: October 10, 2008
Last Update Posted: May 8, 2012
Last Verified: May 2012

Keywords provided by Mauro Maioli, Ospedale Misericordia e Dolce:
Contrast Induced Nephropathy

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases