CINIMA: Effects of Hydration to Prevent Contrast Induced Nephropathy in PCI for ST-elevation Myocardial Infarction.

Sponsor

Arcispedale Santa Maria Nuova-IRCCS (Other)

Overall Status

Completed

CT.gov ID

NCT00639912

Collaborator

Azienda Sanitaria Ospedaliera (Other)

599

Enrollment

Locations

Arms

Duration (Months)

119.8

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the study is to test the efficacy of low versus high volume hydration and two different solutions (sodium chloride versus sodium bicarbonate) in preventing contrast induced nephropathy (CIN) in ST elevation myocardial infarction (STEMI) patients undergoing primary PCI.

Condition or Disease	Intervention/Treatment	Phase
Contrast Induced Nephropathy	Drug: sodium chloride Drug: sodium chloride Drug: sodium bicarbonate Drug: sodium bicarbonate	Phase 4

Detailed Description

Contrast-induced nephropathy (CIN) is associated with increased morbidity and mortality after percutaneous coronary interventions (PCI). Patients with ST elevation myocardial infarction (STEMI) are at high risk for CIN because of hemodynamic instability of the patient, inability to prevent the phenomenon (hydration) and the possible exposure to high volume of contrast media. Recent reports have shown incidence of CIN up to 19% in this population and a related increase of in-hospital mortality.

Merten e coll. (JAMA 2004) reported that sodium bicarbonate infusion before and after contrast exposure in patients with chronic renal failure and without myocardial infarction (AMI) is more effective than sodium chloride in preventing CIN.

Up to date there is no evidence of any effective prophylactic measures in patients with STEMI undergoing primary PCI.

The aim of the study is to test the efficacy of low versus high volume hydration and the efficacy of two different solutions (sodium chloride versus sodium bicarbonate) in preventing CIN in STEMI patients undergoing primary PCI.

The infusion of the randomized solution will start just after randomization and after determination of baseline serum creatinine.

Determination of serum creatinine will be repeated at 24, 48 and 72 hours after randomization. Creatinine clearance will be calculated with Cockroft-Gault formula and MDRD.

Study Design

Study Type:

Interventional

Actual Enrollment :

599 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Randomized Trial on the Effects of Hydration With Sodium Chloride Versus Sodium Bicarbonate to Prevent Contrast Induced Nephropathy, in Patients Undergoing Primary Coronary Interventions for Acute ST Elevation Myocardial Infarction.

Study Start Date :

Jun 1, 2007

Actual Primary Completion Date :

May 1, 2010

Actual Study Completion Date :

Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: A: low volume saline Solution of 154 mEq/L of sodium chloride. Rate of infusion: 1 ml/kg/hour for 12 hours after the procedure, starting in the Cath Lab.	Drug: sodium chloride Solution of 154 mEq/L of sodium chloride. Rate of infusion: 1 ml/Kg/hour for 12 hours. Other Names: Normal saline. Isotonic saline. Sodium chloride 0.9% .
Active Comparator: B: high volume saline Solution of 154 mEq/L of sodium chloride. Rate of infusion: 3 ml/Kg for 1 hour, followed by 1 ml/Kg/hour for 12 hours after the procedure, starting in the Cath lab.	Drug: sodium chloride Solution of 154 mEq/L of sodium chloride. Rate of infusion: 3 ml/Kg for 1 hour, followed by 1 ml/Kg/hour for 12 hours Other Names: Normal saline. Isotonic saline. Sodium Chloride 0.9% .
Active Comparator: C: low volume sodium bicarbonate Solution of 154 mEq/L of sodium bicarbonate. Rate of infusion: 1 ml/Kg/hour for 12 hours after the procedure, starting in the Cath Lab.	Drug: sodium bicarbonate 154 mEq/L of sodium bicarbonate in dextrose solution. Rate of infusion: 1 ml/Kg/hour for 12 hours. Other Names: Addition of 77 ml 8,4% Na bicarbonate to 423 ml 5% dextrose.
Active Comparator: D: high volume sodium bicarbonate Solution of 154 mEq/L of sodium bicarbonate. Rate of infusion: 3 ml/Kg for 1 hour, followed by 1 ml/Kg/hour for 12 hours after the procedure, starting in the Cath Lab.	Drug: sodium bicarbonate 154 mEq/L of sodium chloride in dextrose solution. Rate of infusion: 3 ml/Kg for 1 hour, followed by 1 ml/Kg/hour for 12 hours. Other Names: Addition of 77 ml 8,4% Na bicarbonate to 423 ml 5% dextrose.

Outcome Measures

Primary Outcome Measures

contrast induced nephropathy incidence [24, 48 and 72 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age > 18 years of years
Chest pain lasting at least 30 minutes, non responsive to nitrates, associated to ST elevation of at least 0.2 mV on surface ECG in two or more contiguous leads or to new left bundle branch block.
Informed consent

Exclusion Criteria:

Chronic hemodialytic or peritoneal treatment
Coronary anatomy unsuitable for PCI
Need of emergency coronary artery by-pass grafting
Post-anoxic coma
Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Azienda Ospedaliera Universitaria S. Anna	Ferrara	Emilia-romagna	Italy
2	Nuovo Ospedale Civile di Baggiovara	Modena	Emilia-Romagna	Italy	41100
3	Arcispedale S. Maria Nuova	Reggio Emilia	Emilia-Romagna	Italy	42100
4	Dipartimento di Cardiologia, Ospedale di Lavagna	Lavagna	Genova	Italy	16033
5	Dipartimento di Cardiologia, Ospedale Maggiore	Parma		Italy	43100