This preprint is under consideration at Journal of Cardiothoracic Surgery. A preprint is 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.
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Research Article
Heyman Luckraz
American Hospital Dubai
Corresponding Author
ORCiD: https://orcid.org/0000-0003-1218-1243
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background
Neutrophil gelatinase-associated lipocalin (NGAL) is a recognised biomarker for acute kidney injury (AKI).This study investigated the impact of balanced forced-diuresis using RenalGuard® system (RG), in reducing acute kidney injury (AKI) rates and the associated NGAL levels (6-hour post-CPB plasma level) post adult cardiac surgery with cardiopulmonary bypass (CPB).
Methods
Patients included in the study were at high-risk for AKI post cardiac surgery, namely history of diabetes and/or anaemia, e-GFR 20–60 ml/min/1.73m2, Logistic EuroScore > 5, anticipated CPB time > 120 minutes. Patients were randomized to either RG (n = 110) or managed as per current practice (control = 110). RIFLE-defined AKI rate (based on serum creatinine level increase) within first 3 days of surgery and 6-hour post CPB NGAL levels were the primary and secondary end-points.
Results
Pre & intra-operative characteristics between the two groups were similar (p > 0.05) including the pre-op NGAL levels, the oxygen delivery (ecDO2i) and the carbon dioxide production (ecVCO2i) during CPB. Patients in the RG group had a significantly lower post-operative RIFLE-defined AKI rate compared to control (10% (11/110) v/s 20.9% (23/110), p = 0.03). Overall, median 6-hour post CPB NGAL levels in patients with AKI were significantly higher than those who did not develop AKI (211 vs 150 ng/ml, p < 0.001). Patients managed by balanced forced-diuresis had lower post-operative NGAL levels (146 vs 178 ng/ml, p = 0.09). Using previously reported NGAL cut-off level for AKI (142 ng/ml), binary logistic regression analysis confirmed a beneficial effect of the RG system, with an increased risk of AKI of 2.2 times in the control group (OR 2.2, 95% CI 1.14–4.27, p = 0.02).
Conclusions
Overall, the 6-hour post-CPB plasma NGAL levels were significantly higher in patients who developed AKI.
Patients managed with the novel approach of balanced forced-diuresis, provided by the RenalGuard® system, had a lower AKI rate and lower NGAL levels indicating a lesser degree of renal tissue injury.
Clinical Registration Number
ClinicalTrials.gov website, NCT02974946, https://clinicaltrials.gov/ct2/show/NCT02974946
Keywords
Acute Kidney Injury, Cardiac surgery, RenalGuard® system, Neutrophil Gelatinase-Associated Lipocalin, balanced forced-diuresis
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CURRENT STATUS: Under Review
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Received 11 Mar, 2021
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On 26 Feb, 2021
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Received 26 Feb, 2021
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On 25 Feb, 2021
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On 25 Feb, 2021
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This preprint is under consideration at Journal of Cardiothoracic Surgery. A preprint is 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
Heyman Luckraz
American Hospital Dubai
Corresponding Author
ORCiD: https://orcid.org/0000-0003-1218-1243
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: Under Review
Version 1
Posted 04 Mar, 2021
No community comments so far
Review #1 received
Received 11 Mar, 2021
Reviewer #1 agreed
On 26 Feb, 2021
Reviewers invited
Invitations sent on 26 Feb, 2021
Review #? received
Received 26 Feb, 2021
Editor assigned
On 25 Feb, 2021
Submission checks complete
On 25 Feb, 2021
Editor invited
On 25 Feb, 2021
First submitted
On 24 Feb, 2021
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background
Neutrophil gelatinase-associated lipocalin (NGAL) is a recognised biomarker for acute kidney injury (AKI).This study investigated the impact of balanced forced-diuresis using RenalGuard® system (RG), in reducing acute kidney injury (AKI) rates and the associated NGAL levels (6-hour post-CPB plasma level) post adult cardiac surgery with cardiopulmonary bypass (CPB).
Methods
Patients included in the study were at high-risk for AKI post cardiac surgery, namely history of diabetes and/or anaemia, e-GFR 20–60 ml/min/1.73m2, Logistic EuroScore > 5, anticipated CPB time > 120 minutes. Patients were randomized to either RG (n = 110) or managed as per current practice (control = 110). RIFLE-defined AKI rate (based on serum creatinine level increase) within first 3 days of surgery and 6-hour post CPB NGAL levels were the primary and secondary end-points.
Results
Pre & intra-operative characteristics between the two groups were similar (p > 0.05) including the pre-op NGAL levels, the oxygen delivery (ecDO2i) and the carbon dioxide production (ecVCO2i) during CPB. Patients in the RG group had a significantly lower post-operative RIFLE-defined AKI rate compared to control (10% (11/110) v/s 20.9% (23/110), p = 0.03). Overall, median 6-hour post CPB NGAL levels in patients with AKI were significantly higher than those who did not develop AKI (211 vs 150 ng/ml, p < 0.001). Patients managed by balanced forced-diuresis had lower post-operative NGAL levels (146 vs 178 ng/ml, p = 0.09). Using previously reported NGAL cut-off level for AKI (142 ng/ml), binary logistic regression analysis confirmed a beneficial effect of the RG system, with an increased risk of AKI of 2.2 times in the control group (OR 2.2, 95% CI 1.14–4.27, p = 0.02).
Conclusions
Overall, the 6-hour post-CPB plasma NGAL levels were significantly higher in patients who developed AKI.
Patients managed with the novel approach of balanced forced-diuresis, provided by the RenalGuard® system, had a lower AKI rate and lower NGAL levels indicating a lesser degree of renal tissue injury.
Clinical Registration Number
ClinicalTrials.gov website, NCT02974946, https://clinicaltrials.gov/ct2/show/NCT02974946
Figure 1
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