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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04132921
Other study ID # XYFY2020-KL050-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 25, 2019
Est. completion date November 1, 2020

Study information

Verified date October 2019
Source Xuzhou Medical University
Contact Jindong Liu, M.S
Phone +86-13951355136
Email liujindong1818@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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 .


Recruitment information / eligibility

Status Recruiting
Enrollment 1500
Est. completion date November 1, 2020
Est. primary completion date June 1, 2020
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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;

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China The Affiliated Hospital of Xuzhou Medical University Xuzhou Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
Xuzhou Medical University

Country where clinical trial is conducted

China, 

References & 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 coho — View Citation

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. Review. — View 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. — View 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 — View 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, — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Possible risk factors for AKI after joint replacement Patient's age, gender, height, weight 1 day before surgery
Secondary Intraoperative fluid volume and infusion type Record the total amount of infusion and infusion type of during surgery during sugery and within 7days after surgery
Secondary Hemodynamic changes Focus on the fluctuation of mean arterial pressure during sugery and within 7days after sugery
Secondary Factors related to anesthesia Record the type and dose of anesthetic used in the procedure during sugery and within 7days after sugery
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