Comparison between 2 different hydration strategies (saline solution vs carbonati) for the prevention of contrast induced nephropaty in patients at risk for heart failure undergoing coronary angiography or interventio

• Conditions: Patients undergoing coronary angiography or angioplasty; MedDRA version: 14.1Level: SOCClassification code 10007541Term: Cardiac disordersSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2011-003611-37-IT
• Lead Sponsor: AZIENDA OSPEDALIERA MAGGIORE DELLA CARITA' DI NOVARA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-07
• Last Update Posted: 10 February 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

•Consecutive patients undergoing coronary angiography, followed or not by coronary revascularization, at Cath Lab of U.O. of Universitary Cardiology AOU Maggiore della Carità”, Novara.
•An estimated glomerular filtration rate (GFR) of 60 mL/min or less (calculated by applying the Cockroft-Gault formula) before undergoing coronary angiography.
•An estimated ejection fraction<40% (transthoracic echocardiogram).

•Severe mitro-aortic valve disease estimated by transthoracic echocardiogram also in the presence of an ejection fraction >40%.
•Recent episode af acute pulmonary edema.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 140
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

•Inability to obtain consent.
•Age lower than 18 years old.
•Pregnancy.
•Coronary angiography/or revascularisation in emergency.
•Serious comorbility (shock, cardiac arrest, trauma, etc.).
•An estimated ejection fraction >40% (transthoracic echocardiogram).
•Hystory of contrast intolerance.
•Kidney transplant.
•Periprocedural complications within 48h after the procedure.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to demonstrate the superiority of an experimental hydration CARBONATI” (154 mEq/l in dextrose and water received 3 ml/kg for 1h before contrast exposure followed by an infusion of 1 ml/kg/h for 6h after the procedure) versus isotonic saline solution (standard hydratation) received 0,5 ml/kg/h sodium chloride intravenously for 12 h before and after the procedure, in patients with high risk of acute heart failure ad high risk to develop contrast induced nephropaty, who undergoing coronary angiography, followed or not by coronary revascularization.;Secondary Objective: NA;Primary end point(s): Incidence of contrast-induced nephropaty defined as an increases in serum creatinine concentration either at least 0.5 mg/dl or 25% from baseline within 48 hours after coronary angiography.;Timepoint(s) of evaluation of this end point: 48h after procedure

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Incidence of acute heart failure (pulmunary edema);Timepoint(s) of evaluation of this end point: In 24h from the beginning of hydration