Clinical trial NCT04132921: Risk Factors Related to Postoperative Acute Kidney Injury in Elderly Patients Undergoing Joint Replacement
Official title: Risk Factors Related to Postoperative Acute Kidney Injury in Elderly Patients Undergoing Joint Replacement
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Kidney Injury
Lead sponsor: Xuzhou Medical University
Sponsor class: OTHER
First posted: 2019-10-21
Enrollment: 1500
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients who had undergone joint replacement between January 2014 and October 2019 were included . Patients developed AKI were deemed as cases, and those without AKI were included in the control group.

Brief summary: Total hip arthroplasty refers to the replacement of the femoral head and acetabulum damaged by disease or trauma with an artificial hip joint, thereby restoring joint activity and original function. Acute kidney injury is a common complication after total hip arthroplasty. Previous studies have shown that the incidence of acute kidney injury after hip replacement is as high as 21.9%. Acute kidney injury has become a global safety issue, and the occurrence of acute kidney injury can lead to an increase in hospital stay, medical costs and increased risk of death.There is currently no global survey of the incidence of AKI, and only a number of studies have been conducted on specific patient groups (eg, inpatients, intensive care units \[ICU\] patients or children) due to differences in study design and definition of acute kidney injury.

Detailed description: The incidence and prevalence of different studies vary widely, ranging from 0.32% to 44.30%. There are few studies on the risk factors associated with acute kidney injury after total hip arthroplasty, and early acute kidney injury is often overlooked due to the limitations of the current KDIGO-based diagnostic method. Therefore, it is particularly important for clinicians to understand the risk factors for postoperative acute kidney injury .

Eligibility criteria: Inclusion Criteria:

* Patients age 65 or older
* One-sided joint replacement;
* ASA score grade I-III

Exclusion Criteria:

* Emergency surgery patients;
* Patients with severe liver and kidney dysfunction;
* Missing related data;
* Serious systemic diseases before surgery;

Primary outcomes:
measure: Incidence and outcome of AKI after joint replacement
timeFrame: Within 7 days after surgery
Secondary outcomes:
measure: Possible risk factors for AKI after joint replacement
timeFrame: 1 day before surgery
measure: Intraoperative fluid volume and infusion type
timeFrame: during sugery and within 7days after surgery
measure: Hemodynamic changes
timeFrame: during sugery and within 7days after sugery
measure: Factors related to anesthesia
timeFrame: during sugery and within 7days after sugery
Other outcomes:
Locations:
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
Study officials:
affiliation: The Affiliated Hospital of Xuzhou Medical University
name: Jin Dong Liu, M.S
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bjerregaard LS, Jorgensen CC, Kehlet H; Lundbeck Foundation Centre for Fast-Track Hip and Knee Replacement Collaborative Group. Serious renal and urological complications in fast-track primary total hip and knee arthroplasty; a detailed observational cohort study. Minerva Anestesiol. 2016 Mar 30. Online ahead of print.
citation: Yang L, Xing G, Wang L, Wu Y, Li S, Xu G, He Q, Chen J, Chen M, Liu X, Zhu Z, Yang L, Lian X, Ding F, Li Y, Wang H, Wang J, Wang R, Mei C, Xu J, Li R, Cao J, Zhang L, Wang Y, Xu J, Bao B, Liu B, Chen H, Li S, Zha Y, Luo Q, Chen D, Shen Y, Liao Y, Zhang Z, Wang X, Zhang K, Liu L, Mao P, Guo C, Li J, Wang Z, Bai S, Shi S, Wang Y, Wang J, Liu Z, Wang F, Huang D, Wang S, Ge S, Shen Q, Zhang P, Wu L, Pan M, Zou X, Zhu P, Zhao J, Zhou M, Yang L, Hu W, Wang J, Liu B, Zhang T, Han J, Wen T, Zhao M, Wang H; ISN AKF 0by25 China Consortiums. Acute kidney injury in China: a cross-sectional survey. Lancet. 2015 Oct 10;386(10002):1465-71. doi: 10.1016/S0140-6736(15)00344-X.
citation: Maheshwari K, Turan A, Mao G, Yang D, Niazi AK, Agarwal D, Sessler DI, Kurz A. The association of hypotension during non-cardiac surgery, before and after skin incision, with postoperative acute kidney injury: a retrospective cohort analysis. Anaesthesia. 2018 Oct;73(10):1223-1228. doi: 10.1111/anae.14416. Epub 2018 Aug 24.
citation: Salmasi V, Maheshwari K, Yang D, Mascha EJ, Singh A, Sessler DI, Kurz A. Relationship between Intraoperative Hypotension, Defined by Either Reduction from Baseline or Absolute Thresholds, and Acute Kidney and Myocardial Injury after Noncardiac Surgery: A Retrospective Cohort Analysis. Anesthesiology. 2017 Jan;126(1):47-65. doi: 10.1097/ALN.0000000000001432.
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