An interventional study of Optimal Blood Sampling Site for Point of Care Lactate Assessment using the handled Lactate-Pro 2 device in Blood Lactic Acid Increased and Hip Fractures, sponsored by University Hospitals, Leicester. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-02.
Sponsored by University Hospitals, Leicester · Not applicable, Interventional, and Diagnostic
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)
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.
50 studies on the registry are indexed under Hyperlactatemia; 7 are open to participants now.
This study's enrollment of 50 is above the median of 38 across 32 interventional studies indexed under Hyperlactatemia.
Browse Hyperlactatemia studies →University Hospitals, Leicester is the lead sponsor of 68 studies on the registry; 12 are open to participants now.
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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)
Device: Optimal Blood Sampling Site for Point of Care Lactate Assessment using the handled Lactate-Pro 2 device
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
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?
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.
Plan to share: Yes — De-identified individual participant date for primary outcomes will be made available
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: for 6 months after publication of the study
Access criteria: Data access will be reviewed by an external review panel. Requestors will be required to sign a Data Access Agreement form.
No publications or documents are linked to this record.
Ran from Jul 2018 to primary completion in Mar 2019, 8 months.
Of 17 interventional studies with no phase under Hyperlactatemia, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 12. This study's 8 months is close to that.
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This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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University Hospitals, Leicester