Septic ArthritisNCT04284423
Study of Synovial Lactate Level as Marker of Septic Arthritis
An observational study of Septic Arthritis, run by Khoo Teck Puat Hospital at 1 site in Singapore.
Trial summary
Lactate levels are rapidly available and may potentially aid in diagnosing septic arthritis in a native joint. This study will determine the utility of synovial lactate in discriminating septic from aseptic arthritis. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Septic Arthritis
- What is being tested?
- joint fluid lactate
- How many people
- 200 participants
- Where
- 1 siteSingapore
- Study dates
- 8 Feb 2020to 1 Oct 2021
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients 21 years or older with tender swollen joints undergoing arthrocentesis will be enrolled in the study. Exclusion criteria will be overlying cellulitis, affected prosthetic joints and age under 21.
Who may be able to join
- Age 21 and older
- Suspected infected joint
Who cannot join
- Age under 21
- Prosthetic joint affected
- Overlying cellulitis
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Khoo Teck Puat Hospital
Singapore, 768828
Po Y Huang, MD, 83545302, huangp988@gmail.com
About this study
Lactate levels are rapidly available and may potentially aid in diagnosing septic arthritis in a native joint. This study will determine the utility of synovial lactate in discriminating septic from aseptic arthritis.
Read the detailed description
A painful, swollen joint can be caused by variety of conditions. Distinguishing bacterial arthritis and other causes of arthritis is essential to reducing significant morbidity and mortality. In most cases, septic arthritis is monoarticular and occurs most commonly in large peripheral joints, such as the knee.
Current recommended diagnostic tools include clinical suspicion after examination followed by testing of synovial fluid from the affected joint. The gold standard is often gram stain or synovial fluid culture. The early markers such as synovial WBC, polymorphonuclear white blood cells are not accurate in predicting the diagnosis of septic arthritis. This leads to diagnostic dilemmas, inappropriate admissions, and unnecessary costs pending the results of synovial fluid cultures.
The current emergency department protocol for the diagnosis of septic arthritis states that if none of the following criteria is met, it is unlikely to be septic arthritis:
- synovial fluid white cell count more than 50 000/uL; or
- synovial fluid neutrophil more than 75%; or
- positive gram stain.
However, it has been noted that septic arthritis can have white cell counts lower than 50 000/uL which means that the current protocol cannot safely rule out septic arthritis. A neutrophil percentage of at least 90% has a reported specificity ranging from 68 to 83% while our current protocol uses a cut off of 75% which has a low specificity resulting in many unnecessary admissions. A high neutrophil percentage is also seen in inflammatory joint conditions, and therefore may not be adequate to distinguish infective from non-infective joint pain. A recent review of existing studies in 2011 stated "Future ED-based diagnostic trials are needed to evaluate the role of clinical gestalt and the efficacy of nontraditional synovial markers such as lactate".
The most recent pertinent study was published in Acta Orthopædica Belgica 2014. This was a small retrospective study comparing septic arthritis to aseptic arthritis in samples taken from the emergency department between 2006 and 2013. In the final analysis, lactate was identified as the most accurate early marker in predicting a positive synovial fluid culture. The reported sensitivity was 74.5% with a specificity of 87.2%. This study is limited by its retrospective nature, small sample sizes, and lack of information regarding the prevalence of disease in the local population.
A metanalysis in the Journal of the American Medical Association 2007 cited two studies that reported a prevalence of septic joint in the study population of 8% and 27%. The prevalence of septic joint in our local population is unknown. This study will reveal the incidence of septic joints in the emergency department population.
Review of data from the Khoo Teck Puat Hospital electronic medical records from six months in 2018 reveal 91 synovial joint samples tested for gram stain, culture, or cell count. The investigators expect it will take one year to obtain 200 samples.
- Conditions
- Septic Arthritis
- Being tested
- joint fluid lactate
- Medical subject headings
- Arthritis, Infectious
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
joint fluid lactateDiagnostic test
Analysis of lactate level in joint fluid to determine presence of septic joint
What is being measured
The primary outcome is the main question the study is designed to answer.
Lactate level of synovial fluid
Lactate levels of joint fluid of suspected infected knee joint. The gold standard for infected joint will be performance of washout procedure or positive gram stain or culture.
Measured: The duration of study is one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start8 Feb 2020
- Primary completion1 Feb 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Septic ArthritisStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khoo Teck Puat Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04284423
- Sponsor's protocol ID
- 2019/00501
- Other IDs
- 2019
- Status last verified
- Feb 2020
- First submitted
- 30 Dec 2019
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Margaretten ME, Kohlwes J, Moore D, Bent S. Does this adult patient have septic arthritis? JAMA. 2007 Apr 4;297(13):1478-88. doi: 10.1001/jama.297.13.1478.
PubMed 17405973Lenski M, Scherer MA. The significance of interleukin-6 and lactate in the synovial fluid for diagnosing native septic arthritis. Acta Orthop Belg. 2014 Mar;80(1):18-25.
PubMed 24873080Carpenter CR, Schuur JD, Everett WW, Pines JM. Evidence-based diagnostics: adult septic arthritis. Acad Emerg Med. 2011 Aug;18(8):781-96. doi: 10.1111/j.1553-2712.2011.01121.x.
PubMed 21843213
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Synovial Lactate Level as Marker of Septic Arthritis
- ClinicalTrials.gov ID
- NCT04284423
- Acronym / sponsor ID
- 2019/00501
- Conditions
- Septic Arthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Khoo Teck Puat HospitalUniversity, hospital or other
- Study start
- 8 Feb 2020 (actual)
- Primary completion
- 1 Feb 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 25 Feb 2020 (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.
Lactate levels are rapidly available and may potentially aid in diagnosing septic arthritis in a native joint. This study will determine the utility of synovial lactate in discriminating septic from aseptic arthritis.
Detailed description
A painful, swollen joint can be caused by variety of conditions. Distinguishing bacterial arthritis and other causes of arthritis is essential to reducing significant morbidity and mortality. In most cases, septic arthritis is monoarticular and occurs most commonly in large peripheral joints, such as the knee.
Current recommended diagnostic tools include clinical suspicion after examination followed by testing of synovial fluid from the affected joint. The gold standard is often gram stain or synovial fluid culture. The early markers such as synovial WBC, polymorphonuclear white blood cells are not accurate in predicting the diagnosis of septic arthritis. This leads to diagnostic dilemmas, inappropriate admissions, and unnecessary costs pending the results of synovial fluid cultures.
The current emergency department protocol for the diagnosis of septic arthritis states that if none of the following criteria is met, it is unlikely to be septic arthritis:
- synovial fluid white cell count more than 50 000/uL; or
- synovial fluid neutrophil more than 75%; or
- positive gram stain.
However, it has been noted that septic arthritis can have white cell counts lower than 50 000/uL which means that the current protocol cannot safely rule out septic arthritis. A neutrophil percentage of at least 90% has a reported specificity ranging from 68 to 83% while our current protocol uses a cut off of 75% which has a low specificity resulting in many unnecessary admissions. A high neutrophil percentage is also seen in inflammatory joint conditions, and therefore may not be adequate to distinguish infective from non-infective joint pain. A recent review of existing studies in 2011 stated "Future ED-based diagnostic trials are needed to evaluate the role of clinical gestalt and the efficacy of nontraditional synovial markers such as lactate".
The most recent pertinent study was published in Acta Orthopædica Belgica 2014. This was a small retrospective study comparing septic arthritis to aseptic arthritis in samples taken from the emergency department between 2006 and 2013. In the final analysis, lactate was identified as the most accurate early marker in predicting a positive synovial fluid culture. The reported sensitivity was 74.5% with a specificity of 87.2%. This study is limited by its retrospective nature, small sample sizes, and lack of information regarding the prevalence of disease in the local population.
A metanalysis in the Journal of the American Medical Association 2007 cited two studies that reported a prevalence of septic joint in the study population of 8% and 27%. The prevalence of septic joint in our local population is unknown. This study will reveal the incidence of septic joints in the emergency department population.
Review of data from the Khoo Teck Puat Hospital electronic medical records from six months in 2018 reveal 91 synovial joint samples tested for gram stain, culture, or cell count. The investigators expect it will take one year to obtain 200 samples.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 21 years or older with tender swollen joints undergoing arthrocentesis will be enrolled in the study. Exclusion criteria will be overlying cellulitis, affected prosthetic joints and age under 21.
Key inclusion criteria (2 listed)
- Age 21 and older
- Suspected infected joint
Key exclusion criteria (3 listed)
- Age under 21
- Prosthetic joint affected
- Overlying cellulitis
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 |
|---|---|---|
| joint fluid lactateAnalysis of lactate level in joint fluid to determine presence of septic joint | Diagnostic test | – |
Primary outcome
Lactate level of synovial fluid
Time frame: The duration of study is one year.
Lactate levels of joint fluid of suspected infected knee joint. The gold standard for infected joint will be performance of washout procedure or positive gram stain or culture.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Background: PubMed 17405973Margaretten ME, Kohlwes J, Moore D, Bent S. Does this adult patient have septic arthritis? JAMA. 2007 Apr 4;297(13):1478-88. doi: 10.1001/jama.297.13.1478.
- Background: PubMed 24873080Lenski M, Scherer MA. The significance of interleukin-6 and lactate in the synovial fluid for diagnosing native septic arthritis. Acta Orthop Belg. 2014 Mar;80(1):18-25.
- Background: PubMed 21843213Carpenter CR, Schuur JD, Everett WW, Pines JM. Evidence-based diagnostics: adult septic arthritis. Acad Emerg Med. 2011 Aug;18(8):781-96. doi: 10.1111/j.1553-2712.2011.01121.x.
- 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.
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 Septic Arthritis, run by Khoo Teck Puat Hospital at 1 site in Singapore.
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 3 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 25 Feb 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 Singapore. 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 Po Y Huang, MD (+6583545302, huangp988@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lactate level of synovial fluid (time frame: The duration of study is one year.). 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 NCT04284423, which also lists 3 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 25 Feb 2020.