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 intervention

PRevEntion of cardiac and Vascular pEriprocedural complications in patients undergoiNg coronary angiography or angioplasTy: hydratation vs carbonates to prevent Contrast-Induced Nephropathy in patients undergoing coronary angiography or intervention at risk for Heart Failure (PREVENT-CIN HF). A prospective randomized trial. - PREVENT-CINHF

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-003611-37-IT

Enrollment

240

Registered

2012-03-07

Start date

2011-10-28

Completion date

Unknown

Last updated

2014-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients undergoing coronary angiography or angioplasty MedDRA version: 14.1 Level: SOC Classification code 10007541 Term: Cardiac disorders System Organ Class: 10007541 - Cardiac disorders

Interventions

Pharmaceutical Form: Solution for infusion INN or Proposed INN: SODIUM BICARBONATE CAS Number: 144-55-8 Concentration unit: ml millilitre(s) Concentration type: up to Concentration number: 140- Pharma

Eligibility

Sex/Gender

All

Inclusion criteria

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 fraction40%. • 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

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.

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

Italy

Contacts

Public ContactProf. Giuseppe De Luca

Azienda Ospedaliero-Universitaria Maggiore della Carita' di Novara

p.de_luca@libero.it03213733294

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026