A randomised trial comparing two strategies for preventing kidney failure after angioplasty

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2009
INTERVENTION: All patients undergoing cardiac catheterisation with the intention of percutaneous coronary intervention (definite PCI or catheterisation +/‐ PCI) that meet the inclusion criteria will be randomised to receive prophylactic N‐acetylcysteine or not, with or without iso‐ and low‐osmolar contrast media. Study arms: Arm 1: iso‐osmolar contrast media Arm 2: iso‐osmolar contrast media + N‐acetylcysteine Arm 3: low‐osmolar contrast media Arm 4: low‐osmolar contrast media + N‐acetylcysteine N‐acetylcysteine will be given with a loading dose of 1,200 mg orally prior to the procedure on the day followed by 1,200 mg bulk oral dose for a total of four times (up to 48 hours) after the procedure. Updated 06/08/2014: this trial was stopped before recruitment began in 2011 due to changing practices and procedures, lack of funding and resources and time availability. CONDITION: Kidney function impairment/coronary artery disease/contrast‐induced nephropathy ; Urological and Genital Diseases ; Drug‐ and heavy‐metal‐induced tubulo‐interstitial and tubular conditions PRIMARY OUTCOME: eGFR at 6 months SECONDARY OUTCOME: 1. Contrast‐induced nephropathy. Total duration of follow‐up: 6 months.; 2. eGFR at 14 days; 3. Major Adverse Cardiovascular Events (MACE) ? death, myocardial infarction (MI), stroke, and repeat revascularisation. Total duration of follow‐up: 6 months.; 4. Renal replacement therapy. Total duration of follow‐up: 6 months. INCLUSION CRITERIA: 1. Male and female patients aged 18 years or over 2. Estimated glomerular filtration rate (eGFR) less than 60 ml/m (as calculated by modified Modification of Diet in Renal Disease [MDRD] equation with local laboratory correction factor)
Epistemonikos ID: 610f4d6879e1c1870ebe937092df669a0a8851fe
First added on: Aug 22, 2024