Blood Lactic Acid IncreasedNCT04291989
Optimal Blood Sampling Site for Point of Care Lactate Assessment
A study testing Optimal Blood Sampling Site for Point of Care Lactate Assessment using the handled Lactate-Pro 2 device in people with Blood Lactic Acid Increased and Hip Fractures, run by University Hospitals, Leicester at 1 site in United Kingdom.
Trial summary
The study was to compare blood Lactate levels between ear lobe and finger against venous forearm blood sample using the electronic hand held lactate device in hip fracture patients with good cognitive function (AMT >/= 7) Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Lactic Acid Increased, Hip Fractures
- What is being tested?
- Optimal Blood Sampling Site for Point of Care Lactate Assessment using the handled Lactate-Pro 2 device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Jul 2018to 20 Mar 2019
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female, aged 18 years or above.
- Diagnosed with an acute hip fracture.
- Have a mental test score of 7/10 or greater on assessment during admission.
- Participant is willing to consent to the study.
Who cannot join
- The participant will not enter the study if
- There are Injuries other than isolated hip fracture
- Age <18 years
- They are not willing to consent for the study
- They have a mental test score less than 7/10 at the time of admission.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Leicester Royal Infirmary
Leicester, Please Select, LE1 5WW
About this study
The study was to compare blood Lactate levels between ear lobe and finger against venous forearm blood sample using the electronic hand held lactate device in hip fracture patients with good cognitive function (AMT >/= 7)
Read the detailed description
Following a hip fracture, surgical treatment is advocated to improve pain and mobility. Most patients are elderly and a majority of them are frail. Current best practice tariff and National Institute for health and care excellence guidelines recommends that all those patients who undergo an operation should be performed within 36 hours from the time of injury to optimise recovery and function. The patients need to be medically optimised to undergo a major operation to have their hip fracture fixed. The adequacy of resuscitation is monitored by several clinical and biochemical markers. One of the important markers of resuscitation is serum lactate levels. This is used routinely in polytrauma patients. (Moran and Forward, 2012) The initial interest in lactate in hip fracture patients was based on the philosophy that a hip fracture in a frail elderly patient may be equivalent to a polytrauma in a young fit patient. Subsequently, high serum lactate levels on admission in hip fracture patients have been shown to be associated with higher mortality1. However, at present, this is not routinely monitored in hip fracture patients. Measurement of serum lactate levels presents logistics difficulties, as the blood sample has to be taken to an analyser and analysed within 20 minutes. Hence the investigators want to use a point of care electronic hand held device - the Lactate Pro 2. The investigators have already tested this device against the laboratory analysers and it has been proven to be accurate. However in preliminary testing the investigators found a significant difference between fingertip and earlobe samples in volunteers. The volunteers do not represent our population of interest, which are hip fracture patients. The investigators aim is to determine which sample site; earlobe or fingertip, for Lactate Pro 2 testing best matches venous forearm samples upon which the association of higher mortality with high lactate was based.
Any risk to the patients participating in this study would be very small. The inclusion criteria to participate in this research study is a patient who has had a recent hip fracture awaiting surgery with a Mental Test score of 7/10 or above and is able to consent.
- Conditions
- Blood Lactic Acid Increased, Hip Fractures
- Being tested
- Optimal Blood Sampling Site for Point of Care Lactate Assessment using the handled Lactate-Pro 2 device
- Keywords
- BLOOD LACTATE, EARLOBE SAMPLE, FINGER PRICK SAMPLE
- Medical subject headings
- Hyperlactatemia, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimal Blood Sampling Site for Point of Care Lactate Assessment using the handled Lactate-Pro 2 deviceDevice
This study aims to compare lactate levels using the Lactate Pro 2 device from the same patient at the same time with blood samples taken from three locations - fingertip, earlobe and forearm venepuncture
| Study group | Role | What they receive |
|---|---|---|
| Earlobe and Finger Prick versus venous blood lactate sampling | Experimental | Compare blood Lactate levels between ear lobe and finger against venous forearm blood sample using the electronic hand held lactate device in hip fracture patients with good cognitive function (AMT >/= 7) Receives: Device: Optimal Blood Sampling Site for Point of Care Lactate Assessment using the handled Lactate-Pro 2 device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Finger prick blood sample and earlobe prick blood sample compared to forearm venepuncture blood sample to measure blood Lactate levels in mmol/l using the point of care Lactate-Pro2 device
Which of the two sample sites - finger or earlobe most closely matches the forearm venepuncture blood sample for measuring blood lactate levels?
Measured: The investigators aim to recruit 50 acute hip fracture patients over a time period of upto 6 months for our study. The outcome will be measured only once and recorded at the point of care for each patient.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start18 Jul 2018
- Primary completion20 Mar 2019
- Study completion20 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Lactic Acid IncreasedStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study aims to compare lactate levels from the same patient at the same time with blood samples taken from three locations - fingertip, earlobe and forearm venepuncture
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals, Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- GANAPATHY RAMAN R Perianayagam, FRCS (Orth), Principal investigator, University Hospitals, Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04291989
- Sponsor's protocol ID
- Edge I.D - 90666
- Status last verified
- Feb 2020
- First submitted
- 26 Feb 2020
- Last updated
- 2 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant date for primary outcomes will be made available
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Blood Sampling Site for Point of Care Lactate Assessment
- ClinicalTrials.gov ID
- NCT04291989
- Acronym / sponsor ID
- Edge I.D - 90666
- Conditions
- Blood Lactic Acid Increased, Hip Fractures
- Keywords
- BLOOD LACTATE, EARLOBE SAMPLE, FINGER PRICK SAMPLE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospitals, LeicesterUniversity, hospital or other
- Study start
- 18 Jul 2018 (actual)
- Primary completion
- 20 Mar 2019 (actual)
- Study completion
- 20 Mar 2019 (actual)
- First posted
- 2 Mar 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.
The study was to compare blood Lactate levels between ear lobe and finger against venous forearm blood sample using the electronic hand held lactate device in hip fracture patients with good cognitive function (AMT >/= 7)
Detailed description
Following a hip fracture, surgical treatment is advocated to improve pain and mobility. Most patients are elderly and a majority of them are frail. Current best practice tariff and National Institute for health and care excellence guidelines recommends that all those patients who undergo an operation should be performed within 36 hours from the time of injury to optimise recovery and function. The patients need to be medically optimised to undergo a major operation to have their hip fracture fixed. The adequacy of resuscitation is monitored by several clinical and biochemical markers. One of the important markers of resuscitation is serum lactate levels. This is used routinely in polytrauma patients. (Moran and Forward, 2012) The initial interest in lactate in hip fracture patients was based on the philosophy that a hip fracture in a frail elderly patient may be equivalent to a polytrauma in a young fit patient. Subsequently, high serum lactate levels on admission in hip fracture patients have been shown to be associated with higher mortality1. However, at present, this is not routinely monitored in hip fracture patients. Measurement of serum lactate levels presents logistics difficulties, as the blood sample has to be taken to an analyser and analysed within 20 minutes. Hence the investigators want to use a point of care electronic hand held device - the Lactate Pro 2. The investigators have already tested this device against the laboratory analysers and it has been proven to be accurate. However in preliminary testing the investigators found a significant difference between fingertip and earlobe samples in volunteers. The volunteers do not represent our population of interest, which are hip fracture patients. The investigators aim is to determine which sample site; earlobe or fingertip, for Lactate Pro 2 testing best matches venous forearm samples upon which the association of higher mortality with high lactate was based.
Any risk to the patients participating in this study would be very small. The inclusion criteria to participate in this research study is a patient who has had a recent hip fracture awaiting surgery with a Mental Test score of 7/10 or above and is able to consent.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study aims to compare lactate levels from the same patient at the same time with blood samples taken from three locations - fingertip, earlobe and forearm venepuncture
| Arm | Type | Receives |
|---|---|---|
| Earlobe and Finger Prick versus venous blood lactate sampling | Experimental | Device: Optimal Blood Sampling Site for Point of Care Lactate Assessment using the handled Lactate-Pro 2 deviceCompare blood Lactate levels between ear lobe and finger against venous forearm blood sample using the electronic hand held lactate device in hip fracture patients with good cognitive function (AMT >/= 7) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or Female, aged 18 years or above.
- Diagnosed with an acute hip fracture.
- Have a mental test score of 7/10 or greater on assessment during admission.
- Participant is willing to consent to the study.
Key exclusion criteria (5 listed)
- The participant will not enter the study if
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 |
|---|---|---|
| Optimal Blood Sampling Site for Point of Care Lactate Assessment using the handled Lactate-Pro 2 deviceThis study aims to compare lactate levels using the Lactate Pro 2 device from the same patient at the same time with blood samples taken from three locations - fingertip, earlobe and forearm venepuncture | Device | Earlobe and Finger Prick versus venous blood lactate sampling |
Primary outcome
Finger prick blood sample and earlobe prick blood sample compared to forearm venepuncture blood sample to measure blood Lactate levels in mmol/l using the point of care Lactate-Pro2 device
Time frame: The investigators aim to recruit 50 acute hip fracture patients over a time period of upto 6 months for our study. The outcome will be measured only once and recorded at the point of care for each patient.
Which of the two sample sites - finger or earlobe most closely matches the forearm venepuncture blood sample for measuring blood lactate levels?
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 2 Mar 2020.
- Individual participant dataSharing planned: Yes. De-identified individual participant date for primary outcomes will be made available
Related trials for Blood Lactic Acid Increased
Active, not recruiting
A Validation Study of the Lab Clasp Device: A Point of Care Sepsis Risk Monitor
Sepsis, Sepsis Bacterial
RecruitingObservational study
Effect of Preoperative Prewarming on Serum Lactate Levels in Patients Undergoing Elective Nephrectomy
Nephrectomy / Methods, Intraoperative Hypothermia
Recruiting
Electric Cardiometry-Guided Standard Versus Restricted Fluid Therapy In Robotic Prostaectomy
Prostate Cancer, Surgery
Recruiting
Role of Elevated Lactate Levels on Lipid and Carbohydrate Metabolism.
Hyperlactatemia, Metabolic Syndrome (MetS)
Not yet recruitingObservational study
Submental Tissue Oxygenation and Arterial Lactate in Major Surgery
Microcirculatory Dysfunction, Tissue Hypoperfusion
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.
GANAPATHY RAMAN R Perianayagam, FRCS (Orth) principal investigator
University Hospitals, Leicester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimal Blood Sampling Site for Point of Care Lactate Assessment using the handled Lactate-Pro 2 device in people with Blood Lactic Acid Increased and Hip Fractures, run by University Hospitals, Leicester at 1 site in United Kingdom.
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 4 inclusion and 5 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 2 Mar 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 United Kingdom. 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?
Finger prick blood sample and earlobe prick blood sample compared to forearm venepuncture blood sample to measure blood Lactate levels in mmol/l using the point of care Lactate-Pro2 device (time frame: The investigators aim to recruit 50 acute hip fracture patients over a time period of upto 6 months for our study. The outcome will be measured only once and recorded at the point of care for each patient.). 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 2 Mar 2020.