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Hydration and Contrast-Induced Nephropathy in Primary Angioplasty

This study has been completed.
Information provided by (Responsible Party):
Mauro Maioli, Ospedale Misericordia e Dolce Identifier:
First received: October 9, 2008
Last updated: May 6, 2012
Last verified: May 2012
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: 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 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
Drug: Placebo


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00770614

Ospedale Misericordia e Dolce
Prato, Italy, 59100
Sponsors and Collaborators
Ospedale Misericordia e Dolce
Principal Investigator: Mauro Maioli, MD Ospedale Misericordia e Dolce, Prato
  More Information

Responsible Party: Mauro Maioli, MD, Ospedale Misericordia e Dolce Identifier: NCT00770614     History of Changes
Other Study ID Numbers: Prato0703
Study First Received: October 9, 2008
Last Updated: May 6, 2012

Keywords provided by Ospedale Misericordia e Dolce:
Contrast Induced Nephropathy

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases processed this record on April 26, 2017