Acute Kidney InjuryNCT04132921
Risk Factors Related to Postoperative Acute Kidney Injury in Elderly Patients Undergoing Joint Replacement
An observational study of Acute Kidney Injury, run by Xuzhou Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 25 Oct 2019to 1 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- Patients age 65 or older
- One-sided joint replacement;
- ASA score grade I-III
Who cannot join
- Emergency surgery patients;
- Patients with severe liver and kidney dysfunction;
- Missing related data;
- Serious systemic diseases before surgery;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu
Jin Dong Liu, M.S, +86-13951355136, liujindong1818@163.com
About this study
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.
Read the 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 .
- Conditions
- Acute Kidney Injury
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with AKI | Patients with AKI after joint replacement | |
| Patients without AKI | Patients without AKI after joint replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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;
Measured: Within 7 days after surgery
Secondary outcomes (4)
Possible risk factors for AKI after joint replacement
Patient's age, gender, height, weight
Measured: 1 day before surgery
Intraoperative fluid volume and infusion type
Record the total amount of infusion and infusion type of during surgery
Measured: during sugery and within 7days after surgery
Hemodynamic changes
Focus on the fluctuation of mean arterial pressure
Measured: during sugery and within 7days after sugery
Factors related to anesthesia
Record the type and dose of anesthetic used in the procedure
Measured: during sugery and within 7days after sugery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
- Study start25 Oct 2019
- Primary completion1 Jun 2020
- Study completion1 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Dong Liu, Xuzhou Medical University
- Investigators
- Jin Dong Liu, M.S, Principal investigator, The Affiliated Hospital of Xuzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04132921
- Sponsor's protocol ID
- XYFY2020-KL050-01
- Status last verified
- Oct 2019
- First submitted
- 11 Oct 2019
- Last updated
- 11 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27028450Yang 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.
PubMed 26466051Maheshwari 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.
PubMed 30144029Salmasi 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.
PubMed 27792044Magder 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.
PubMed 24736333
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors Related to Postoperative Acute Kidney Injury in Elderly Patients Undergoing Joint Replacement
- ClinicalTrials.gov ID
- NCT04132921
- Acronym / sponsor ID
- XYFY2020-KL050-01
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Xuzhou Medical UniversityUniversity, hospital or other
- Study start
- 25 Oct 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Nov 2020 (estimated)
- First posted
- 21 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with AKI | – | –Patients with AKI after joint replacement |
| Patients without AKI | – | –Patients without AKI after joint replacement |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (3 listed)
- Patients age 65 or older
- One-sided joint replacement;
- ASA score grade I-III
Key exclusion criteria (4 listed)
- Emergency surgery patients;
- Patients with severe liver and kidney dysfunction;
- Missing related data;
- Serious systemic diseases before surgery;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence and outcome of AKI after joint replacement
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;
4 secondary outcomes
Possible risk factors for AKI after joint replacement
Time frame: 1 day before surgery
Intraoperative fluid volume and infusion type
Time frame: during sugery and within 7days after surgery
Hemodynamic changes
Time frame: during sugery and within 7days after sugery
Factors related to anesthesia
Time frame: during sugery and within 7days after sugery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
- Results publication: PubMed 27028450Bjerregaard 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.
- Results publication: PubMed 26466051Yang 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.
- Results publication: PubMed 30144029Maheshwari 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.
- Results publication: PubMed 27792044Salmasi 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.
- Results publication: PubMed 24736333Magder 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin Dong Liu, M.S principal investigator
The Affiliated Hospital of Xuzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by Xuzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jindong Liu, M.S (+86-13951355136, liujindong1818@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and outcome of AKI after joint replacement (time frame: Within 7 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04132921, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2020.