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Perioperative Clinical Trials in AKI.

ABSTRACT: To characterize current evidence and current foci of perioperative clinical trials, we systematically reviewed Medline and identified perioperative trials involving 100 or more adult patients undergoing surgery and reporting renal end points that were published in high-impact journals since 2004. We categorized the 101 trials identified based on the nature of the intervention and summarized major trial findings from the five categories most applicable to perioperative management of patients. Trials that targeted ischemia suggested that increasing perioperative renal oxygen delivery with inotropes or blood transfusion does not reliably mitigate acute kidney injury (AKI), although goal-directed therapy with hemodynamic monitors appeared beneficial in some trials. Trials that have targeted inflammation or oxidative stress, including studies of nonsteroidal anti-inflammatory drugs, steroids, N-acetylcysteine, and sodium bicarbonate, have not shown renal benefits, and high-dose perioperative statin treatment increased AKI in some patient groups in two large trials. Balanced crystalloid intravenous fluids appear safer than saline, and crystalloids appear safer than colloids. Liberal compared with restrictive fluid administration reduced AKI in a recent large trial in open abdominal surgery. Remote ischemic preconditioning, although effective in several smaller trials, failed to reduce AKI in two larger trials. The translation of promising preclinical therapies to patients undergoing surgery remains poor, and most interventions that reduced perioperative AKI compared novel surgical management techniques or existing processes of care rather than novel pharmacologic interventions.

SUBMITTER: McIlroy DR

PROVIDER: S-EPMC7172010 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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Perioperative Clinical Trials in AKI.

McIlroy David R DR Lopez Marcos G MG Billings Frederic T FT

Seminars in nephrology 20200301 2

To characterize current evidence and current foci of perioperative clinical trials, we systematically reviewed Medline and identified perioperative trials involving 100 or more adult patients undergoing surgery and reporting renal end points that were published in high-impact journals since 2004. We categorized the 101 trials identified based on the nature of the intervention and summarized major trial findings from the five categories most applicable to perioperative management of patients. Tri ...[more]

PMID: 32303280

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Project description:Although Muscle Invasive Bladder Cancer (MIBC) is increasing in incidence, treatment has largely remained limited to radical cystectomy with or without cisplatin-based neoadjuvant and/or adjuvant chemotherapy. We reviewed the current and recent clinical trials evaluating perioperative chemotherapy, targeted therapy, and novel therapeutic regimens for MIBC patients undergoing radical cystectomy.An overview of perioperative MIBC management was conducted initially using MEDLINE. The Clinical Trials Registry and MEDLINE were further searched specifically for perioperative MIBC chemotherapy, targeted therapy, and other novel therapeutic approaches. Trials involving non-perioperative management, operative management other than radical cystectomy, multiple tumors, or purely superficial or metastatic disease were excluded from selection. These criteria were not specifically fulfilled for mTOR inhibitor and immune therapy trials. Only phase III chemotherapy and phase II targeted therapy trials found in the Clinical Trials Registry were selected. MEDLINE searches of specific treatments were limited to January 2009 to January 2014 whereas the Clinical Trials Registry search had no timeline. Systematic MEDLINE searches had no phase restrictions. Trials known by the authors to fulfill search criteria but were not found via searches were also selected.Twenty-five trials were selected from the Clinical Trials Registry including 7 phase III chemotherapy trials, 11 Phase II targeted therapy trials, 3 immune therapy trials, 1 mammalian target of rapamycin (mTOR) inhibitor trial, and 3 gene and vaccine therapy trials. Nine trials have been completed and 5 have been terminated early or withdrawn. Nine trials have data available when individually searched using MEDLINE and/or Google. Systematic searches of MEDLINE separately found 12 trials in the past 5 years. Two phase III chemotherapy trials were selected based on knowledge by the authors. No phase III trials of targeted therapy have been registered or published.New trials are currently being conducted that may revolutionize MIBC treatment preceding or following cystectomy. Head-to-head phase III trials of perioperative chemotherapy and further phase II and phase III trials of targeted therapy and other therapeutic approaches are necessary before the current cisplatin-based perioperative chemotherapy paradigm is altered.

Project description:BACKGROUND:Acute kidney injury (AKI) is assoicated with high mortality and measures to improve risk stratification and early identification have been urgently called for. This study investigated whether an electronic clinical prediction rule (CPR) combined with an AKI e-alert could reduce hospital-acquired AKI (HA-AKI) and improve associated outcomes. METHODS AND FINDINGS:A controlled before-and-after study included 30,295 acute medical admissions to two adult non-specialist hospital sites in the South of England (two ten-month time periods, 2014-16); all included patients stayed at least one night and had at least two serum creatinine tests. In the second period at the intervention site a CPR flagged those at risk of AKI and an alert was generated for those with AKI; both alerts incorporated care bundles. Patients were followed-up until death or hospital discharge. Primary outcome was change in incident HA-AKI. Secondary outcomes in those developing HA-AKI included: in-hospital mortality, AKI progression and escalation of care. On difference-in-differences analysis incidence of HA-AKI reduced (odds ratio [OR] 0.990, 95% CI 0.981-1.000, P = 0.049). In-hospital mortality in HA-AKI cases reduced on difference-in-differences analysis (OR 0.924, 95% CI 0.858-0.996, P = 0.038) and unadjusted analysis (27.46% pre vs 21.67% post, OR 0.731, 95% CI 0.560-0.954, P = 0.021). Mortality in those flagged by the CPR significantly reduced (14% pre vs 11% post intervention, P = 0.008). Outcomes for community-acquired AKI (CA-AKI) cases did not change. A number of process measures significantly improved at the intervention site. Limitations include lack of randomization, and generalizability will require future investigation. CONCLUSIONS:In acute medical admissions a multi-modal intervention, including an electronically integrated CPR alongside an e-alert for those developing HA-AKI improved in-hospital outcomes. CA-AKI outcomes were not affected. The study provides a template for investigations utilising electronically generated prediction modelling. Further studies should assess generalisability and cost effectiveness. TRIAL REGISTRATION:Clinicaltrials.org NCT03047382.

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Perioperative Clinical Trials in AKI.

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Perioperative Clinical Trials in AKI.

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