Hydration and Contrast-Induced Nephropathy in Primary Angioplasty

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mauro Maioli, Ospedale Misericordia e Dolce
ClinicalTrials.gov Identifier:
NCT00770614
First received: October 9, 2008
Last updated: May 6, 2012
Last verified: May 2012
  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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Adverse clinical events within 1 month, including in-hospital death and need for dialysis or hemofiltration [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Mauro Maioli, MD, Ospedale Misericordia e Dolce
ClinicalTrials.gov Identifier: NCT00770614     History of Changes
Other Study ID Numbers: Prato0703, POCARD0703
Study First Received: October 9, 2008
Last Updated: May 6, 2012
Health Authority: Italy: National Bioethics Committee

Keywords provided by Ospedale Misericordia e Dolce:
Contrast Induced Nephropathy

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on August 28, 2014