Overview

A Prospective Study on Incidence and Prevention of Contrast-induced Nephropathy in Croatia

Status:
Completed
Trial end date:
2016-04-01
Target enrollment:
0
Participant gender:
All
Summary
The study is analysis of the incidence of contrast-induced nephropathy (CIN) in patients with previously normal renal function undergoing angiography and comparison between the three different treatment protocols on renal function. Patients are randomly assigned to the three groups: 1) peroral hydration, 2) Na bicarbonate (NaHCO3), and 3) NaHCO3 plus N-acetylcysteine (NAC) infusion. Serum creatinine (SCr), blood urea nitrogen (BUN), and neutrophil gelatinase-associated lipocalin (NGAL) are measured before and 48 hours after the angiography. CIN was defined as an absolute increase of 0.5 mg/dL or a relative increase of >25% in creatinine levels 48-72 hours after the procedure
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Clinical Hospital Centre Zagreb
Treatments:
Acetylcysteine
N-monoacetylcystine
Criteria
Inclusion Criteria:

- angina (stable, unstable)

- coronary artery disease

- cardiomyopathy

- valvular disease

- vasculitis

- peripheral arterial disease

Exclusion Criteria:

- kidney dysfunction

- uncontrolled hypertension (systolic blood pressure >160 mm Hg and/or diastolic blood
pressure >100 mm Hg)

- pregnancy

- lactation

- history of allergic reaction to contrast agents

- cardiogenic shock

- pulmonary edema

- multiple myeloma

- urgent coronary angiography

- receiving contrast agents two days prior to the study and 48 hours within the study