Arthroplasty, Replacement, KneedexpolviNCT02642731
Kidney Biomarkers of Acute Kidney Injury in Patients With Knee Arthroplasty
An observational study of Arthroplasty, Replacement, Knee and Acute Kidney Injury, run by Kuopio University Hospital at 1 site in Finland.
Trial summary
Sensitive renal markers have been studied abundantly in connection with open heart, liver and transplantation surgery; however in major orthopaedic surgery their use is anecdotal. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Arthroplasty, Replacement, Knee, Acute Kidney Injury
- How many people
- 30 participants
- Where
- 1 siteFinland
- Study dates
- Sep 2013to Dec 2015
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients coming to elective knee arthroplasty
Who may be able to join
- informed consent
- allergy to NSAIDs
Who cannot join
- no informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Kidney Biomarkers of Acute Kidney Injury in Patients With Knee Arthroplasty- a Pilot Study
Sensitive renal markers have been studied abundantly in connection with open heart, liver and transplantation surgery; however in major orthopaedic surgery their use is anecdotal. The aim of the present study is to evaluate use of sensitive renal markers, NGAL (Neutrophil gelatinase associated lipocalin ), KIM-1 (Kidney injury molecule- 1), LFABP (liver-type fatty acid-binding protein), and IL-18 (interleukin -18), in patients coming for elective TKA (total knee arthroplasty) as a pilot study before large study concerning acute kidney injury in orthopaedic surgery.
Read the detailed description
Acute renal deterioration is a serious adverse event in elective surgery. Serum creatinine based diagnostics of acute kidney injury may delay diagnosis and produce false negative results since serum creatinine is affected by diet, muscle mass, used hydration therapy. In recent times new markers have been developed and tested in order to find sensitive, fast and reliable marker of renal deterioration.
- Keywords
- total knee arthroplasty, Kidney function, Renal markers
- 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 for elective TKA | patients with normal or near normal plasma creatinine who come for elective total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal function
S-creatinine, Cystatin C, estimated GFR
Measured: time zero hours to 48 hours
Secondary outcomes (1)
Concentraton of sensitive renal markers
U-NGAL, P-NGAL, U-KIM-1, U-IL-18
Measured: time zero hours to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2015 (estimated)
- Study startSep 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, KneeStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merja Kokki, Kuopio University Hospital
- Investigators
- Merja Kokki, MD, PhD, Principal investigator, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02642731
- Sponsor's protocol ID
- 2013-03-07
- Acronym
- dexpolvi
- Status last verified
- Feb 2018
- First submitted
- 25 Dec 2015
- Last updated
- 27 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kidney Biomarkers of Acute Kidney Injury in Patients With Knee Arthroplasty- a Pilot Study
- ClinicalTrials.gov ID
- NCT02642731
- Acronym / sponsor ID
- dexpolvi / 2013-03-07
- Keywords
- total knee arthroplasty, Kidney function, Renal markers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 30 Dec 2015 (estimated)
- 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.
Sensitive renal markers have been studied abundantly in connection with open heart, liver and transplantation surgery; however in major orthopaedic surgery their use is anecdotal. The aim of the present study is to evaluate use of sensitive renal markers, NGAL (Neutrophil gelatinase associated lipocalin ), KIM-1 (Kidney injury molecule- 1), LFABP (liver-type fatty acid-binding protein), and IL-18 (interleukin -18), in patients coming for elective TKA (total knee arthroplasty) as a pilot study before large study concerning acute kidney injury in orthopaedic surgery.
Detailed description
Acute renal deterioration is a serious adverse event in elective surgery. Serum creatinine based diagnostics of acute kidney injury may delay diagnosis and produce false negative results since serum creatinine is affected by diet, muscle mass, used hydration therapy. In recent times new markers have been developed and tested in order to find sensitive, fast and reliable marker of renal deterioration.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients for elective TKA | – | –patients with normal or near normal plasma creatinine who come for elective total knee arthroplasty |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients coming to elective knee arthroplasty
Key inclusion criteria (2 listed)
- informed consent
- allergy to NSAIDs
Key exclusion criteria (1 listed)
- no informed consent
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
Renal function
Time frame: time zero hours to 48 hours
S-creatinine, Cystatin C, estimated GFR
1 secondary outcome
Concentraton of sensitive renal markers
Time frame: time zero hours to 24 hours
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 27 Feb 2018.
- 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.
Merja Kokki, MD, PhD principal investigator
Kuopio University Hospital
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 Arthroplasty, Replacement, Knee and Acute Kidney Injury, run by Kuopio University Hospital at 1 site in Finland.
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 2 inclusion and 1 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 27 Feb 2018. 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 Finland. 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?
Renal function (time frame: time zero hours to 48 hours). 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 27 Feb 2018.