Risk Factors Related to Postoperative Acute Kidney Injury in Elderly Patients Undergoing Joint Replacement

NCT04132921 | Unknown DMC

• 1 other identifier: XYFY2020-KL050-01
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Incidence and outcome of AKI after joint replacement

  AKI can be diagnosed if one of the following conditions is true: (1) Serum creatinine increases by ≥26.5 μmol/L (0.3 mg / dl) within 48 h; (2)Serum creatinine rises more than 1.5 times of the baseline value, and is significantly or presumably the above situation occurred within 7 days;

  Within 7 days after surgery

Secondary Outcomes (4)

• Possible risk factors for AKI after joint replacement

  1 day before surgery

• Intraoperative fluid volume and infusion type

  during sugery and within 7days after surgery

• Hemodynamic changes

  during sugery and within 7days after sugery

• Factors related to anesthesia

  during sugery and within 7days after sugery

Study Arms (2)

Patients with AKI

Patients with AKI after joint replacement

Patients without AKI

Patients without AKI after joint replacement

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Xuzhou Medical University: lead

Study Sites (1)

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

RECRUITING

Related Publications (5)

• 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.

  PMID: 27028450 RESULT

• 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.

  PMID: 26466051 RESULT

• 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.

  PMID: 30144029 RESULT

• 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.

  PMID: 27792044 RESULT

• Magder SA. The highs and lows of blood pressure: toward meaningful clinical targets in patients with shock. Crit Care Med. 2014 May;42(5):1241-51. doi: 10.1097/CCM.0000000000000324.

  PMID: 24736333 RESULT

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Jin Dong Liu, M.S

  The Affiliated Hospital of Xuzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jindong Liu, M.S

CONTACT

+86-13951355136; liujindong1818@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The Affiliated Hospital of Xuzhou Medical University

Study Record Dates

• First Submitted: October 11, 2019
• First Posted: October 21, 2019
• Study Start: October 25, 2019
• Primary Completion: June 1, 2020
• Study Completion: November 1, 2020
• Last Updated: August 11, 2020

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)