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Risk Factors Related to Postoperative Acute Kidney Injury in Elderly Patients Undergoing Total Hip Arthroplasty

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ClinicalTrials.gov Identifier: NCT04132921
Recruitment Status : Not yet recruiting
First Posted : October 21, 2019
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
Jin Dong Liu, Xuzhou Medical University

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.

Condition or disease
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 .

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Study Type : Observational
Estimated Enrollment : 690 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Risk Factors Related to Postoperative Acute Kidney Injury in Elderly Patients Undergoing Total Hip Arthroplasty
Estimated Study Start Date : October 25, 2019
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : November 1, 2020

Group/Cohort
Patients with AKI
Patients with AKI after total hip arthroplasty
Patients without AKI
Patients without AKI after total hip arthroplasty



Primary Outcome Measures :
  1. Incidence and outcome of AKI after Total Hip Arthroplasty [ Time Frame: Within 7 days after surgery ]
    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;


Secondary Outcome Measures :
  1. Possible risk factors for AKI after Total Hip Arthroplasty [ Time Frame: 1 day before surgery ]
    Patient's age, gender, height, weight

  2. Intraoperative fluid volume and infusion type [ Time Frame: during sugery and within 7days after surgery ]
    Record the total amount of infusion and infusion type of during surgery

  3. Hemodynamic changes [ Time Frame: during sugery and within 7days after sugery ]
    Focus on the fluctuation of mean arterial pressure

  4. Factors related to anesthesia [ Time Frame: during sugery and within 7days after sugery ]
    Record the type and dose of anesthetic used in the procedure



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients who had undergone total hip arthroplasty 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.
Criteria

Inclusion Criteria:

  • Patients age 65 or older
  • One-sided total hip arthroplasty;
  • 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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04132921


Contacts
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Contact: Jindong Liu, M.S +86-13951355136 liujindong1818@163.com

Locations
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China, Jiangsu
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Sponsors and Collaborators
Xuzhou Medical University
Investigators
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Principal Investigator: Jin Dong Liu, M.S The Affiliated Hospital of Xuzhou Medical University

Publications of Results:

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Responsible Party: Jin Dong Liu, The Affiliated Hospital of Xuzhou Medical University, Xuzhou Medical University
ClinicalTrials.gov Identifier: NCT04132921     History of Changes
Other Study ID Numbers: XYFY-2019-0018
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acute Kidney Injury
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases