Is there a renoprotective value to leukodepletion during heart valve surgery? A randomized controlled trial (ROLO)

Department of Cardiothoracic Surgery, Freeman Hospital, High Heaton, Newcastle upon Tyne, NE7 7DN, UK. Espeed.Khoshbin1@nhs.net. School of Health and Medicine, Lancaster University, Bailing, Upper Market Street, Lancaster, Lancashire, LA1 4YW, UK. Renal Unit, Lancashire Teaching Hospitals NHS Foundation Trust, Sharoe Green Lane, Fulwood, Preston, Lancashire, PR2 9HT, UK. Department of Cardiothoracic Surgery, Blackpool Victoria Hospital, Blackpool, FY3 8NR, UK. Department of Cardiothoracic Surgery, Freeman Hospital, High Heaton, Newcastle upon Tyne, NE7 7DN, UK. Department of Public Health, University of Oxford, Rosemary Rue Building, Old Road Campus, Headington, Oxford, OX3 7LF, UK. Clinical Trials and Evaluation Unit, Bristol Medical School, University of Bristol, Bristol, BS2 8HW, UK.

Journal of cardiothoracic surgery. 2021;16(1):58
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Abstract
BACKGROUND Acute Kidney Injury (AKI) adversely affects outcomes after cardiac surgery. A major mediator of AKI is the activation of leukocytes through exposure to the cardiopulmonary bypass circuit. We evaluate the use of leukodepletion filters throughout bypass to protect against post-operative AKI by removing activated leukocytes during cardiac surgery. METHODS This is a single-centre, double-blind, randomized controlled trial comparing the use of leukodepletion versus a standard arterial filter throughout bypass. Elective adult patients undergoing heart valve surgery with or without concomitant procedures were investigated. The primary clinical outcome measured was the development of AKI according to the KDIGO criteria. Secondary measures included biomarkers of renal tubular damage (urinary Retinol Binding Protein and Kidney Injury Molecule-1), glomerular kidney injury (urinary Micro Albumin and serum Cystatin C) and urinary Neutrophil Gelatinase Associated Lipocalin, as well as the length of hospital stay and quality of life measures through EQ-5D-5L questionnaires. RESULTS The ROLO trial randomized 64 participants with a rate of recruitment higher than anticipated (57% achieved, 40% anticipated). The incidence of AKI was greater in the leukodepletion filter group (44% versus 23%, risk difference 21, 95% CI - 2 to 44%). This clinical finding was supported by biomarker levels especially by a tendency toward glomerular insult at 48 h, demonstrated by a raised serum Cystatin C (mean difference 0.11, 95% CI 0.00 to 0.23, p = 0.068) in the leukodepleted group. There was however no clear association between the incidence or severity of AKI and length of hospital stay. On average, health related quality of life returned to pre-operative levels in both groups within 3 months of surgery. CONCLUSIONS Leukocyte depletion during cardiopulmonary bypass does not significantly reduce the incidence of AKI after valvular heart surgery. Other methods to ameliorate renal dysfunction after cardiac surgery need to be investigated. TRIAL REGISTRATION The trial was registered by the International Standard Randomized Controlled Trial Number Registry ISRCTN42121335 . Registered on the 18 February 2014. The trial was run by the Bristol Clinical Trials and Evaluation Unit. This trial was financially supported by the National Institute of Health Research (Research for Patient Benefit), award ID: PB-PG-0711-25,090.
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Language : eng
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