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Dietary restriction for prevention of contrast-induced acute kidney injury in patients undergoing percutaneous coronary angiography: a randomized controlled trial.

ABSTRACT: Short-term dietary restriction (DR) may prevent organ damage from ischemic or toxic insults in animals, but clear evidence in humans is missing. While especially intraarterial administration of contrast media represents a cause of hospital-acquired acute kidney injury (AKI), targeted preventive strategies are not available. This trial investigated the feasibility and effectiveness of pre-interventional DR for preventing AKI in patients undergoing percutaneous coronary intervention (PCI). Patients were randomized to receive a formula diet containing 60% of daily energy requirement (DR group) or ad-libitum food during the 4-day-interval before PCI. Primary endpoint was change of serum creatinine 48?h after PCI (?creatinine). Further analyses included incidence of AKI and safety evaluation. ?creatinine post PCI in the DR group vs. the control group did not show any difference (DR: 0.03(-0.15,0.14)mg/dL vs. control: 0.09(-0.03,0.22)mg/dL;p?=?0.797). Subgroup analyses revealed a significant beneficial impact of DR in patients that received ?100?ml of contrast agent (DR n?=?26: ?creatinine -0.03(-0.20,0.08)mg/dL vs. control n?=?24: ?creatinine 0.10(-0.08,0.24)mg/dL; p?=?0.041) and in patients with ?2 risk factors for AKI (DR: n?=?27; ?creatinine -0.01(-0.18,0.07)mg/dL vs. control n?=?31: ?creatinine 0.09(-0.03,0.16)mg/dl; p?=?0.030). Although the primary endpoint was not met, the results of this trial suggest a beneficial impact of DR in low-to-moderate risk patients.

SUBMITTER: Grundmann F

PROVIDER: S-EPMC7089976 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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Dietary restriction for prevention of contrast-induced acute kidney injury in patients undergoing percutaneous coronary angiography: a randomized controlled trial.

Grundmann Franziska F Müller Roman-Ulrich RU Hoyer-Allo Karla Johanna Ruth KJR Späth Martin Richard MR Passmann Eva E Becker Ingrid I Pfister Roman R Baldus Stephan S Benzing Thomas T Burst Volker V

Scientific reports 20200323 1

Short-term dietary restriction (DR) may prevent organ damage from ischemic or toxic insults in animals, but clear evidence in humans is missing. While especially intraarterial administration of contrast media represents a cause of hospital-acquired acute kidney injury (AKI), targeted preventive strategies are not available. This trial investigated the feasibility and effectiveness of pre-interventional DR for preventing AKI in patients undergoing percutaneous coronary intervention (PCI). Patient ...[more]

PMID: 32251303

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Project description:ImportanceAcute kidney injury (AKI) after percutaneous coronary intervention (PCI) is common, morbid, and costly; increases patients' mortality risk; and can be mitigated by limiting contrast use.ObjectiveTo examine the national variation in AKI incidence and contrast use among US physicians and the variation's association with patients' risk of developing AKI after PCI.Design, setting, and participantsThis cross-sectional study used the American College of Cardiology National Cardiovascular Data Registry (NCDR) CathPCI Registry to identify in-hospital care for PCI in the United States. Participants included 1?349?612 patients who underwent PCI performed by 5973 physicians in 1338 hospitals between June 1, 2009, and June 30, 2012. Data analysis was performed from July 1, 2014, to August 31, 2016.Main outcomes and measuresThe primary outcome was AKI, defined according to the Acute Kidney Injury Network criteria as an absolute increase of 0.3 mg/dL or more or a relative increase of 50% or more from preprocedural to peak creatinine. A secondary outcome was the mean contrast volume as reported in the NCDR CathPCI Registry. Physicians who performed more than 50 PCIs per year were the main exposure variable of interest. Hierarchical regression with adjustment for patients' AKI risk was used to identify the variation in AKI rates, the variation in contrast use, and the association of contrast volume with patients' predicted AKI risk.ResultsOf the 1?349?612 patients who underwent PCI, the mean (SD) age was 64.9 (12.2) years, 908 318 (67.3%) were men, and 441 294 (32.7%) were women. Acute kidney injury occurred in 94?584 patients (7%). A large variation in AKI rates was observed among individual physicians ranging from 0% to 30% (unadjusted), with a mean adjusted 43% excess likelihood of AKI (median odds ratio, 1.43; 95% CI, 1.41-1.44) for statistically identical patients presenting to 2 random physicians. A large variation in physicians' mean contrast volume, ranging from 79 mL to 487 mL with an intraclass correlation coefficient of 0.23 (interquartile range, 0.21-0.25), was also observed, implying a 23% variation in contrast volume among physicians after adjustment. There was minimal correlation between contrast use and patients' AKI risk (r?=?-0.054). Sensitivity analysis after excluding complex cases showed that the physician variation in AKI remained unchanged.Conclusions and relevanceAcute kidney injury rates vary greatly among physicians, who also vary markedly in their use of contrast and do not use substantially less contrast in patients with higher risk for AKI. These findings suggest an important opportunity to reduce AKI by reducing the variation in contrast volumes across physicians and lowering its use in higher-risk patients.

Project description:BackgroundContrast-induced acute kidney injury (CI-AKI) is a complication commonly associated with invasive angiographic procedures and is considered the leading cause of hospital-acquired acute kidney injury. CI-AKI can lead to a prolonged hospital stay, with a substantial economic impact, and increased mortality. The DyeVert™ PLUS EZ system (FDA approved and CE marked) is a device that has been developed to divert a portion of the theoretical injected contrast media volume (CMV), reducing the overall volume of contrast media injected and aortic reflux, and potentially improving long-term health outcomes.ObjectivesTo assess the long-term costs and health outcomes associated with the introduction of the DyeVert™ PLUS EZ system into the UK health care service for the prevention of CI-AKI in a cohort of patients with chronic kidney disease (CKD) stage 3-4 undergoing diagnostic coronary angiography (DAG) and/or percutaneous coronary intervention (PCI), and to compare these costs and outcomes with those of the current practice.MethodsA de novo economic model was developed based on the current pathway of managing patients undergoing DAG and/or PCI and on evidence related to the clinical effectiveness of DyeVert™ in terms of its impact on relevant clinical outcomes and health service resource use. Clinical data used to populate the model were derived from the literature or were based on assumptions informed by expert clinical input. Costs included in the model were from the NHS and personal social services perspective and obtained from the literature and UK-based routine sources. Probabilistic distributions were assigned to the majority of model parameters so that a probabilistic analysis could be undertaken, while deterministic sensitivity analyses were also carried out to explore the impact of key parameter variation on the model results.ResultsBase-case results indicate that the intervention leads to cost savings (- £435) and improved effectiveness (+ 0.028 QALYs) over the patient's lifetime compared with current practice. Output from the probabilistic analysis points to a high likelihood of the intervention being cost-effective across presented willingness-to-pay (WTP) thresholds. The overall long-term cost saving for the NHS associated with the introduction of the DyeVert™ PLUS EZ system is over £19.7 million for each annual cohort of patients. The cost savings are mainly driven by a lower risk of subsequent diseases and their associated costs.ConclusionsThe introduction of the DyeVert™ PLUS EZ system has the potential to reduce costs for the health care service and yield improved clinical outcomes for patients with CKD stage 3-4 undergoing angiographic procedures.

Project description:Hydration with sodium bicarbonate is one of the strategies to prevent contrast-induced acute kidney injury (CI-AKI). The purpose of this study was to determine how strong is the evidence for sodium bicarbonate to prevent CI-AKI after coronary angiography (CAG) and/or percutaneous coronary intervention (PCI).We conducted PubMed, EMBASE, and CENTRAL databases to search for randomized controlled trials (RCTs) comparing the efficacy of sodium bicarbonate with sodium chloride to prevent CI-AKI after CAG and/or PCI. Relative risk (RR), standardized mean difference (SMD), or weighted mean difference (WMD) with 95% confidence intervals (CIs) was calculated. Heterogeneity, publication bias, and study quality were evaluated, sensitivity analyses, cumulative analyses, and subgroup analyses were performed. The risk of random errors was assessed by trial sequential analysis (TSA).Sixteen RCTs (3537 patients) met the eligibility criteria. Hydration with sodium bicarbonate showed significant beneficial effects in preventing CI-AKI (RR 0.67; 95% CI: 0.47-0.96, P?=?0.029), decreasing the change in serum creatinine (SCr) (SMD -0.31 95% CI: -0.55 to -0.07, P?=?0.011) and estimated glomerular filtration rate (eGFR) (SMD -0.17 95% CI: -0.30 to -0.04, P?=?0.013). But no significant differences were observed in the requirement for dialysis (RR 1.11; 95% CI: 0.60-2.07, P?=?0.729), mortality (RR 0.71; 95% CI: 0.41-1.21, P?=?0.204) and reducing the length of hospital stay (LHS) (WMD -1.47; 95% CI: -4.14 to 1.20, P?=?0.279). The result of TSA on incidence of CI-AKI showed the required information size (RIS?=?6614) was not reached and cumulative z curve did not cross TSA boundary. The result of TSA on the requirement for dialysis and mortality demonstrated the required information sizes (RIS?=?170,510 and 19,516, respectively) were not reached, and the cumulative z-curve did not cross any boundaries.The evidence that sodium bicarbonate reduces the incidence of CI-AKI is encouraging but more well-designed randomized controlled trails are required to allow definitive firm conclusion to be drawn.

Dataset Information

Dietary restriction for prevention of contrast-induced acute kidney injury in patients undergoing percutaneous coronary angiography: a randomized controlled trial.

Publications

Dietary restriction for prevention of contrast-induced acute kidney injury in patients undergoing percutaneous coronary angiography: a randomized controlled trial.

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