Early Hydration in Acute Myocardial Infarction
This study is currently recruiting participants.
Verified April 2013 by Ospedale Misericordia e Dolce
Sponsor:
Ospedale Misericordia e Dolce
Information provided by (Responsible Party):
Mauro Maioli, Ospedale Misericordia e Dolce
ClinicalTrials.gov Identifier:
NCT01742130
First received: December 2, 2012
Last updated: April 1, 2013
Last verified: April 2013
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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 nephropathy in patients undergoing primary coronary intervention for acute ST elevation myocardial infarction.
| Condition | Intervention | Phase |
|---|---|---|
|
Contrast Induced Acute Kidney Injury |
Drug: sodium bicarbonate solution Drug: Isotonic saline |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Early Hydration in Acute Myocardial Infarction: Sodium Bicarbonate Versus Saline for the Prevention on Contrast-induced Acute Kidney Injury |
Resource links provided by NLM:
Further study details as provided by Ospedale Misericordia e Dolce:
Primary Outcome Measures:
- Incidence of contrast-induced acute kidney injury [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]contrast-induced acute kidney injury is defined as an increase in serum creatinine >= 0.3 mg/dL over the baseline value within 2 days after the administration of the contrast medium
Secondary Outcome Measures:
- adverse clinical events [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]adverse clinical events within 1 month including in-hospital death and need for dialysis or hemofiltration
| Estimated Enrollment: | 300 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Sodium bicarbonate
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
Other Name: 154 mEq/L in dextrose and H2O
|
|
Active Comparator: Saline
Sodium Saline 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: Isotonic saline
Other Name: 0.9% sodium chloride
|
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Consecutive patients with AMI candidates for primary PCI presenting within 12 h of symptom onset with ST-segment elevation of more 1 mm in at least two contiguous leads of electrocardiogram.
Exclusion Criteria:
- contrast medium administration within the 10 days
- end-stage renal failure requiring dialysis
- refusal to give informed consent
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01742130
Contacts
| Contact: Mauro Maioli, MD | +390574434270 | mauro.maioli@fastwebnet.it |
| Contact: Anna Toso, MD | +390574434270 | anna.toso@libero.it |
Locations
| Italy | |
| Ospedale Misericordia e Dolce | Recruiting |
| Prato, Italy, 59100 | |
| Contact: Mauro Maioli, MD +390574434270 mauro.maioli@fastwebnet.it | |
| Contact: Anna Toso, MD +390574434270 anna.toso@libero.it | |
| Principal Investigator: Mauro Maioli, MD | |
| Sub-Investigator: Anna Toso, MD | |
| Sub-Investigator: Mario Leoncini, MD | |
| Sub-Investigator: Francesco Bellandi, MD | |
| Sub-Investigator: Nicola Musilli, MD | |
Sponsors and Collaborators
Ospedale Misericordia e Dolce
More Information
No publications provided
| Responsible Party: | Mauro Maioli, Medical Doctor, Ospedale Misericordia e Dolce |
| ClinicalTrials.gov Identifier: | NCT01742130 History of Changes |
| Other Study ID Numbers: | Prato0705 |
| Study First Received: | December 2, 2012 |
| Last Updated: | April 1, 2013 |
| Health Authority: | Italy: National Bioethics Committee |
Keywords provided by Ospedale Misericordia e Dolce:
|
Contrast-induced nephropathy Contrast media Angiography Coronary percutaneous intervention |
Additional relevant MeSH terms:
|
Infarction Acute Kidney Injury Myocardial Infarction Ischemia Pathologic Processes Necrosis Renal Insufficiency |
Kidney Diseases Urologic Diseases Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013