Acute Kidney InjuryNCT05595694
Acute Kidney Injury After Elective Total Joint Arthroplasty
An observational study of Acute Kidney Injury, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Total joint arthroplasty (TJA) is a common orthopedic procedure to treat patients with end-stage knee arthritis. Over 4,000 TJA were performed in the Hong Kong public hospitals in the past 12 months (July 2020 - June 2021) and the demand for this procedure is ever increasing with time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 1,077 participants
- Where
- 1 siteHong Kong
- Study dates
- 31 Oct 2022to 25 Jan 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients underwent elective primary and revision TJA in Queen Mary Hospital, Hong Kong from from January 2018 to December 2021.
Who may be able to join
- Patients data in our database who underwent elective primary and revision TJA in Queen Mary Hospital, Hong Kong from from January 2018 to December 2021.
Who cannot join
- Patients with rheumatoid arthritis.
- Missing of essential data.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence and Duration of Acute Kidney Injury After Elective Total Joint Arthroplasty With The Use of Perioperative Celecoxib as One of the Multimodal Analgesia Regime: A Retrospective Case Control Study
Total joint arthroplasty (TJA) is a common orthopedic procedure to treat patients with end-stage knee arthritis. Over 4,000 TJA were performed in the Hong Kong public hospitals in the past 12 months (July 2020 - June 2021) and the demand for this procedure is ever increasing with time. TJA are rehabilitative surgeries with an aim to accelerate patient ambulation and minimize hospital stay. To facilitate this process, multi-disciplinary enhanced recovery after surgery (ERAS) programs are implemented. This involves surgeons, anaesthetists, physiotherapists and nurses who follow an integrated care pathway to allow early patient mobilization and hospital discharge. The program reduces the hospital length of stay and this can reduce the risk of complications and mortality. One of the major challenges in TJA is postoperative pain. TJA is a very painful procedure with up to 50% of patients have moderate to severe pain (numeric rating scale >4) immediately after surgery. This can delay patient mobilization and hinder postoperative recovery. Severe postoperative pain is also associated with an increased risk of infection, myocardial ischaemia, respiratory complications and the development of chronic pain. Therefore, an effective multimodal analgesia is an essential component in the ERAS program. It combines different oral analgesics to limit opioid use and its related side effects. Celecoxib has been shown to reduce pain and opioid use after TJA. It is therefore recommended to be used routinely. However, its potential nephrotoxic property has led to its judicious use, especially in patients with preoperative chronic renal failure. Postoperative acute kidney injury (AKI) is an independent risk factor for mortality, cardiovascular complications and hospital length of stay6. However, the studies assessing the incidence of AKI following TJA are scarce, and with conflicting results.
Therefore, the aim of our study is to retrospectively review the incidence and duration of AKI following elective TJA in a tertiary institution. We will evaluate the effect of celecoxib in our multimodal analgesia regimen on the risk of postoperative AKI and determine the risk factors associated.
- Conditions
- Acute Kidney Injury
- Being tested
- No intervention
- 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.
No interventionOther
This is a retrospective review of 1320 patients in our database who underwent elective primary and revision TJA in Queen Mary Hospital, Hong Kong from from January 2018 to December 2021. No intervention was involved.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute kidney injury
Daily serum creatinine level from postoperative day 0 up to day 5
Measured: From postoperative day 0 to day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start31 Oct 2022
- Primary completion31 Dec 2022
- Study completion25 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 1,077 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Chan Chi-Wing, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05595694
- Sponsor's protocol ID
- UW22-230
- Status last verified
- Nov 2023
- First submitted
- 23 Oct 2022
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Duration of Acute Kidney Injury After Elective Total Joint Arthroplasty With The Use of Perioperative Celecoxib as One of the Multimodal Analgesia Regime: A Retrospective Case Control Study
- ClinicalTrials.gov ID
- NCT05595694
- Acronym / sponsor ID
- UW22-230
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,077 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 25 Jan 2023 (actual)
- First posted
- 27 Oct 2022 (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 joint arthroplasty (TJA) is a common orthopedic procedure to treat patients with end-stage knee arthritis. Over 4,000 TJA were performed in the Hong Kong public hospitals in the past 12 months (July 2020 - June 2021) and the demand for this procedure is ever increasing with time. TJA are rehabilitative surgeries with an aim to accelerate patient ambulation and minimize hospital stay. To facilitate this process, multi-disciplinary enhanced recovery after surgery (ERAS) programs are implemented. This involves surgeons, anaesthetists, physiotherapists and nurses who follow an integrated care pathway to allow early patient mobilization and hospital discharge. The program reduces the hospital length of stay and this can reduce the risk of complications and mortality. One of the major challenges in TJA is postoperative pain. TJA is a very painful procedure with up to 50% of patients have moderate to severe pain (numeric rating scale >4) immediately after surgery. This can delay patient mobilization and hinder postoperative recovery. Severe postoperative pain is also associated with an increased risk of infection, myocardial ischaemia, respiratory complications and the development of chronic pain. Therefore, an effective multimodal analgesia is an essential component in the ERAS program. It combines different oral analgesics to limit opioid use and its related side effects. Celecoxib has been shown to reduce pain and opioid use after TJA. It is therefore recommended to be used routinely. However, its potential nephrotoxic property has led to its judicious use, especially in patients with preoperative chronic renal failure. Postoperative acute kidney injury (AKI) is an independent risk factor for mortality, cardiovascular complications and hospital length of stay6. However, the studies assessing the incidence of AKI following TJA are scarce, and with conflicting results.
Therefore, the aim of our study is to retrospectively review the incidence and duration of AKI following elective TJA in a tertiary institution. We will evaluate the effect of celecoxib in our multimodal analgesia regimen on the risk of postoperative AKI and determine the risk factors associated.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients underwent elective primary and revision TJA in Queen Mary Hospital, Hong Kong from from January 2018 to December 2021.
Key inclusion criteria (1 listed)
- Patients data in our database who underwent elective primary and revision TJA in Queen Mary Hospital, Hong Kong from from January 2018 to December 2021.
Key exclusion criteria (2 listed)
- Patients with rheumatoid arthritis.
- Missing of essential data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThis is a retrospective review of 1320 patients in our database who underwent elective primary and revision TJA in Queen Mary Hospital, Hong Kong from from January 2018 to December 2021. No intervention was involved. | Other | – |
Primary outcome
Incidence of acute kidney injury
Time frame: From postoperative day 0 to day 5
Daily serum creatinine level from postoperative day 0 up to day 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Individual participant dataSharing planned: No
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WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
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Acute Kidney Injury, Hypotension (MeSH: D007022)
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.
The record lists no contact. Use the official record to reach the sponsor.
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 The University of Hong Kong at 1 site in Hong Kong.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 1 Dec 2023. 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 Hong Kong. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of acute kidney injury (time frame: From postoperative day 0 to day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Dec 2023.