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. 2022 Jan;26(7):1–286. doi: 10.3310/UGEZ4120

Biomarkers for assessing acute kidney injury for people who are being considered for admission to critical care: a systematic review and cost-effectiveness analysis.

Miriam Brazzelli, Lorna Aucott, Magaly Aceves-Martins, Clare Robertson, Elisabet Jacobsen, Mari Imamura, Amudha Poobalan, Paul Manson, Graham Scotland, Callum Kaye, Simon Sawhney, Dwayne Boyers
PMCID: PMC8859769  PMID: 35115079

Abstract

BACKGROUND

Acute kidney injury is a serious complication that occurs in the context of an acute critical illness or during a postoperative period. Earlier detection of acute kidney injury may facilitate strategies to preserve renal function, prevent further disease progression and reduce mortality. Acute kidney injury diagnosis relies on a rise in serum creatinine levels and/or fall in urine output; however, creatinine is an imperfect marker of kidney function. There is interest in the performance of novel biomarkers used in conjunction with existing clinical assessment, such as NephroCheck® (Astute Medical, Inc., San Diego, CA, USA), ARCHITECT® urine neutrophil gelatinase-associated lipocalin (NGAL) (Abbott Laboratories, Abbott Park, IL, USA), and urine and plasma BioPorto NGAL (BioPorto Diagnostics A/S, Hellerup, Denmark) immunoassays. If reliable, these biomarkers may enable earlier identification of acute kidney injury and enhance management of those with a modifiable disease course.

OBJECTIVE

The objective was to evaluate the role of biomarkers for assessing acute kidney injury in critically ill patients who are considered for admission to critical care.

DATA SOURCES

Major electronic databases, conference abstracts and ongoing studies were searched up to June 2019, with no date restrictions. MEDLINE, EMBASE, Health Technology Assessment Database, Cumulative Index to Nursing and Allied Health Literature, Cochrane Central Register of Controlled Trials, Web of Science, World Health Organization Global Index Medicus, EU Clinical Trials Register, International Clinical Trials Registry Platform and ClinicalTrials.gov were searched.

REVIEW METHODS

A systematic review and meta-analysis were conducted to evaluate the performance of novel biomarkers for the detection of acute kidney injury and prediction of other relevant clinical outcomes. Random-effects models were adopted to combine evidence. A decision tree was developed to evaluate costs and quality-adjusted life-years accrued as a result of changes in short-term outcomes (up to 90 days), and a Markov model was used to extrapolate results over a lifetime time horizon.

RESULTS

A total of 56 studies (17,967 participants), mainly prospective cohort studies, were selected for inclusion. No studies addressing the clinical impact of the use of biomarkers on patient outcomes, compared with standard care, were identified. The main sources of bias across studies were a lack of information on blinding and the optimal threshold for NGAL. For prediction studies, the reporting of statistical details was limited. Although the meta-analyses results showed the potential ability of these biomarkers to detect and predict acute kidney injury, there were limited data to establish any causal link with longer-term health outcomes and there were considerable clinical differences across studies. Cost-effectiveness results were highly uncertain, largely speculative and should be interpreted with caution in the light of the limited evidence base. To illustrate the current uncertainty, 15 scenario analyses were undertaken. Incremental quality-adjusted life-years were very low across all scenarios, ranging from positive to negative increments. Incremental costs were also small, in general, with some scenarios generating cost savings with tests dominant over standard care (cost savings with quality-adjusted life-year gains). However, other scenarios generated results whereby the candidate tests were more costly with fewer quality-adjusted life-years, and were thus dominated by standard care. Therefore, it was not possible to determine a plausible base-case incremental cost-effectiveness ratio for the tests, compared with standard care.

LIMITATIONS

Clinical effectiveness and cost-effectiveness results were hampered by the considerable heterogeneity across identified studies. Economic model predictions should also be interpreted cautiously because of the unknown impact of NGAL-guided treatment, and uncertain causal links between changes in acute kidney injury status and changes in health outcomes.

CONCLUSIONS

Current evidence is insufficient to make a full appraisal of the role and economic value of these biomarkers and to determine whether or not they provide cost-effective improvements in the clinical outcomes of acute kidney injury patients.

FUTURE WORK

Future studies should evaluate the targeted use of biomarkers among specific patient populations and the clinical impact of their routine use on patient outcomes and management.

STUDY REGISTRATION

This study is registered as PROSPERO CRD42019147039.

FUNDING

This project was funded by the National Institute for Health Research (NIHR) Evidence Synthesis programme and will be published in full in Health Technology Assessment; Vol. 26, No. 7. See the NIHR Journals Library website for further project information.

Plain language summary

Among people who are very ill or have undergone surgery, the kidneys may suddenly stop working properly. This is known as acute kidney injury. Acute kidney injury can progress to serious kidney problems and can be fatal. Currently, to decide whether or not acute kidney injury is present, doctors use the level of creatinine (a waste product filtered by the kidneys) in the blood or urine. However, creatinine levels are not a precise indicator and they can take hours or days to rise; this may lead to delays in acute kidney injury recognition. Novel biomarkers may help doctors to recognise the presence of acute kidney injury earlier and treat patients promptly. This work evaluates current evidence on the use of biomarkers for acute kidney injury with respect to clinical usefulness and costs. We reviewed the current evidence on the use of biomarkers for assessing the risk of acute kidney injury among people who are very ill, and assessed whether or not the evidence was of good value for the NHS. We assessed the ARCHITECT® urine neutrophil gelatinase-associated lipocalin (NGAL) (Abbott Laboratories, Abbott Park, IL, USA), urine and plasma BioPorto NGAL (BioPorto Diagnostics A/S, Hellerup, Denmark) and urine NephroCheck® (Astute Medical, Inc., San Diego, CA, USA) biomarkers. We checked studies published up to June 2019 and found 56 relevant studies (17,967 patients). Most studies were conducted outside the UK and investigated people already admitted to critical care. We combined the results of the studies and found that NephroCheck and NGAL biomarkers might be useful in identifying acute kidney injury or pre-empting acute kidney injury in some circumstances. However, studies differed in patient characteristics, clinical setting and the way in which biomarkers were used. This could explain why the number of people correctly identified and missed by the biomarkers varied across studies. Hence, we do not completely trust the pooled results. We also found that acute kidney injury is associated with substantial costs for the NHS, but there was insufficient good-quality evidence to decide which biomarker (if any) offered the best value for money.

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