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临床试验/NCT07132619
NCT07132619已完成不适用

Predictors and Outcomes of Acute Kidney Injury After Pulmonary Endarterectomy: A Single-Centre Retrospective Study

Ebru Girgin Dinc2 个研究点 分布在 2 个国家目标入组 150 人开始时间: 2024年6月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
2
主要终点
Association Between Total Circulatory Arrest Duration and Incidence of Postoperative Acute Kidney Injury

研究概览

简要总结

This retrospective, single-centre observational study evaluates perioperative determinants and clinical outcomes of postoperative acute kidney injury (AKI) in patients undergoing pulmonary endarterectomy (PEA) between 2018 and 2020. AKI is classified according to KDIGO 2012 criteria using both serum creatinine changes and urine output over 48 hours. Preoperative, intraoperative and postoperative variables are assessed using multivariable logistic regression. Intraoperative time variables - including extracorporeal circulation (ECC) duration, deep hypothermic circulatory arrest (DHCA) duration and aortic cross-clamp time - are entered simultaneously to identify which component independently captures renal risk. The study also evaluates a parsimonious multivariable risk-stratification model based on routinely available perioperative data. Secondary outcomes include 30-day mortality, intensive care unit stay, hospital length of stay and renal replacement therapy requirement. Findings from this study may provide insights into perioperative risk stratification and renal monitoring strategies in patients undergoing pulmonary endarterectomy.

详细描述

Pulmonary endarterectomy (PEA) is the established curative treatment for chronic thromboembolic pulmonary hypertension (CTEPH). Despite favourable haemodynamic outcomes, postoperative acute kidney injury (AKI) is a frequent and clinically relevant complication, reported in 7.1% to 57.5% of PEA series.

This retrospective observational study was conducted at a tertiary referral centre for PEA. Of 126 consecutive adult patients screened between January 2018 and December 2020, 117 were included in the primary analysis after applying predefined exclusion criteria and excluding one patient with insufficient postoperative renal data for KDIGO staging.

AKI was defined according to KDIGO 2012 criteria using both serum creatinine and urine output assessed over 48 hours. Four separate multivariable logistic regression models were constructed: Model A assessed preoperative variables; Model B assessed intraoperative time variables including ECC duration, DHCA duration and ACC time entered simultaneously; Model C assessed clinical and postoperative variables; and Model D was a parsimonious combined model incorporating variables identified as independent determinants across Models A through C.

Model discrimination was evaluated using receiver operating characteristic analysis with 95% confidence intervals estimated by non-parametric bootstrapping. Model calibration was assessed using the Hosmer-Lemeshow test, and bootstrap internal validation with 1000 resamples was used to estimate optimism-corrected AUC for the combined model. Linearity of the association between ECC duration and AKI was examined using restricted cubic spline modelling.

ECC duration, rather than DHCA or aortic cross-clamp duration, was the intraoperative time variable independently associated with AKI. Age was the principal preoperative determinant, and early postoperative albumin was independently associated with lower AKI odds. Despite comparable haemodynamic improvement in both groups, 30-day mortality was significantly higher in patients who developed AKI.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18-85 years
  • Underwent pulmonary endarterectomy between 2018 and 2020

排除标准

  • Age below 18 years
  • Pregnant women

结局指标

主要结局

Association Between Total Circulatory Arrest Duration and Incidence of Postoperative Acute Kidney Injury

时间窗: up to 48 hours, postoperatively

The presence or absence of postoperative acute kidney injury (AKI) will be determined according to KDIGO 2012 criteria, based on both changes in serum creatinine and hourly urine output within the first 48 hours after surgery. The primary measure will be the relationship between total circulatory arrest (TCA) duration (in minutes) and the occurrence of AKI, analyzed as a binary variable (yes/no).

次要结局

  • Severity of Acute Kidney Injury According to KDIGO Staging(up to 48 hours, postoperatively)
  • Length of Intensive Care Unit Stay(up to 30 days postoperatively)
  • In-Hospital Mortality(up to 30 days postoperatively)

研究者

发起方
Ebru Girgin Dinc
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ebru Girgin Dinc

M.D., Anesthesiologist

Koşuyolu Kartal Heart Training and Research Hospital

研究点 (2)

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