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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 hours, 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-0711-25090.
Keywords
cardiac surgery, heart valve, cardiopulmonary bypass, acute kidney injury, leukodepletion
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CURRENT STATUS: Published
View the published article at Journal of Cardiothoracic Surgery.
Version 1
Posted 17 Jul, 2020
No community comments so far
Reviewer #2 agreed
On 25 Dec, 2020
Review #2 received
Received 25 Dec, 2020
Editorial decision: Minor revision
On 25 Dec, 2020
Review #1 received
Received 07 Aug, 2020
Reviewers invited
Invitations sent on 26 Jul, 2020
Reviewer #1 agreed
On 26 Jul, 2020
Editor assigned
On 13 Jul, 2020
Submission checks complete
On 12 Jul, 2020
Editor invited
On 12 Jul, 2020
First submitted
On 10 Jul, 2020
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HTML Views: ...
Subject Areas
Cardiothoracic Surgery
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See the published version of this preprint at Journal of Cardiothoracic Surgery.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research article
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
View the published article at Journal of Cardiothoracic Surgery.
Version 1
Posted 17 Jul, 2020
No community comments so far
Reviewer #2 agreed
On 25 Dec, 2020
Review #2 received
Received 25 Dec, 2020
Editorial decision: Minor revision
On 25 Dec, 2020
Review #1 received
Received 07 Aug, 2020
Reviewers invited
Invitations sent on 26 Jul, 2020
Reviewer #1 agreed
On 26 Jul, 2020
Editor assigned
On 13 Jul, 2020
Submission checks complete
On 12 Jul, 2020
Editor invited
On 12 Jul, 2020
First submitted
On 10 Jul, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Cardiothoracic Surgery
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at Journal of Cardiothoracic Surgery.
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 hours, 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-0711-25090.
Figure 1
Figure 2
Figure 3
This is a list of supplementary files associated with this preprint. Click to download.
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