Prevention of Cardiac Surgery-Associated Acute Kidney Injury by Implementing the KDIGO Guidelines in High-Risk Patients Identified by Biomarkers: The PrevAKI-Multicenter Randomized Controlled Trial.

Acute Kidney Injury / diagnosis Aged Biomarkers / urine Cardiac Surgical Procedures / adverse effects Europe Feasibility Studies Female Guideline Adherence / standards Humans Insulin-Like Growth Factor Binding Proteins / urine Male Middle Aged Patient Care Bundles / standards Practice Guidelines as Topic / standards Predictive Value of Tests Risk Assessment Risk Factors Time Factors Tissue Inhibitor of Metalloproteinase-2 / urine Treatment Outcome

Journal

Anesthesia and analgesia

ISSN: 1526-7598

Titre abrégé: Anesth Analg

Pays: United States

ID NLM: 1310650

Informations de publication

Date de publication:
01 08 2021

Historique:

pubmed: 9 3 2021

medline: 14 9 2021

entrez: 8 3 2021

Statut: ppublish

Résumé

Prospective, single-center trials have shown that the implementation of the Kidney Disease: Improving Global Outcomes (KDIGO) recommendations in high-risk patients significantly reduced the development of acute kidney injury (AKI) after surgery. We sought to evaluate the feasibility of implementing a bundle of supportive measures based on the KDIGO guideline in high-risk patients undergoing cardiac surgery in a multicenter setting in preparation for a large definitive trial. In this multicenter, multinational, randomized controlled trial, we examined the adherence to the KDIGO bundle consisting of optimization of volume status and hemodynamics, functional hemodynamic monitoring, avoidance of nephrotoxic drugs, and prevention of hyperglycemia in high-risk patients identified by the urinary biomarkers tissue inhibitor of metalloproteinases-2 [TIMP-2] and insulin growth factor-binding protein 7 [IGFBP7] after cardiac surgery. The primary end point was the adherence to the bundle protocol and was evaluated by the percentage of compliant patients with a 95% confidence interval (CI) according to Clopper-Pearson. Secondary end points included the development and severity of AKI. In total, 278 patients were included in the final analysis. In the intervention group, 65.4% of patients received the complete bundle as compared to 4.2% in the control group (absolute risk reduction [ARR] 61.2 [95% CI, 52.6-69.9]; P < .001). AKI rates were statistically not different in both groups (46.3% intervention versus 41.5% control group; ARR -4.8% [95% CI, -16.4 to 6.9]; P = .423). However, the occurrence of moderate and severe AKI was significantly lower in the intervention group as compared to the control group (14.0% vs 23.9%; ARR 10.0% [95% CI, 0.9-19.1]; P = .034). There were no significant effects on other specified secondary outcomes. Implementation of a KDIGO-derived treatment bundle is feasible in a multinational setting. Furthermore, moderate to severe AKI was significantly reduced in the intervention group.

Sections du résumé

BACKGROUND

METHODS

In this multicenter, multinational, randomized controlled trial, we examined the adherence to the KDIGO bundle consisting of optimization of volume status and hemodynamics, functional hemodynamic monitoring, avoidance of nephrotoxic drugs, and prevention of hyperglycemia in high-risk patients identified by the urinary biomarkers tissue inhibitor of metalloproteinases-2 [TIMP-2] and insulin growth factor-binding protein 7 [IGFBP7] after cardiac surgery. The primary end point was the adherence to the bundle protocol and was evaluated by the percentage of compliant patients with a 95% confidence interval (CI) according to Clopper-Pearson. Secondary end points included the development and severity of AKI.

RESULTS

In total, 278 patients were included in the final analysis. In the intervention group, 65.4% of patients received the complete bundle as compared to 4.2% in the control group (absolute risk reduction [ARR] 61.2 [95% CI, 52.6-69.9]; P < .001). AKI rates were statistically not different in both groups (46.3% intervention versus 41.5% control group; ARR -4.8% [95% CI, -16.4 to 6.9]; P = .423). However, the occurrence of moderate and severe AKI was significantly lower in the intervention group as compared to the control group (14.0% vs 23.9%; ARR 10.0% [95% CI, 0.9-19.1]; P = .034). There were no significant effects on other specified secondary outcomes.

CONCLUSIONS

Implementation of a KDIGO-derived treatment bundle is feasible in a multinational setting. Furthermore, moderate to severe AKI was significantly reduced in the intervention group.

Identifiants

DOI: 10.1213/ANE.0000000000005458 PMID: 33684086

pubmed: 33684086

doi: 10.1213/ANE.0000000000005458

pii: 00000539-202108000-00002

doi:

Substances chimiques

Biomarkers 0

Insulin-Like Growth Factor Binding Proteins 0

TIMP2 protein, human 0

insulin-like growth factor binding protein-related protein 1 0

Tissue Inhibitor of Metalloproteinase-2 127497-59-0

Banques de données

ClinicalTrials.gov

['NCT03244514']

Types de publication

Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

Pagination

292-302

Informations de copyright

Déclaration de conflit d'intérêts

Conflicts of Interest: See Disclosures at the end of the article.

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