Lactate Blood IncreaseNCT05611398
Lactate Monitoring in Traumatic Long Bone Fractures Requiring Emergent Surgical Intervention
An observational study of Lactate Blood Increase and Trauma Blunt, run by Arrowhead Regional Medical Center at 1 site in United States.
Trial summary
Serum lactate has been utilized as a standard in guiding management of orthopedic injuries. Elevated preoperative lactate has been associated with a higher likelihood of postoperative complications. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lactate Blood Increase, Trauma Blunt, Trauma, Secondary
- What is being tested?
- Orthopedic Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 164 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to 1 Jan 2022
- Phase
- Observational
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study was completed at the Arrowhead Regional Medical Center (ARMC) in San Bernardino County, California. The ARMC is a 456-bed acute-care teaching facility and ACS-verified level I trauma center. The ARMC emergency department (ED) is one of the busiest in the state of California with more than 100,000 visits and over 3,000 adult trauma cases annually.
Who may be able to join
- All patients aged 18 years or higher with long bone fractures with Injury Severity Score <16
Who cannot join
- Non-long bone fracture surgeries performed within the first 72 hours
- Patients who underwent external fixation prior to surgery
- Patients with inconsistent or incomplete chart data Patients with polytrauma and life-threatening injuries.
Trial locations and contacts
1 site in 1 country.
United States1 site
Arrowhead Regional Medical Center
Colton, California, 92324
About this study
Official title: Analysis of Lactate Monitoring Requirement in Emergent Surgical Interventions in Noncritical Traumatic Long Bone Fractures
Serum lactate has been utilized as a standard in guiding management of orthopedic injuries. Elevated preoperative lactate has been associated with a higher likelihood of postoperative complications. However, lactate's role in guiding operative timing in non-critical long-bone fractures has not been previously explored. This study investigates lactate's role in guiding surgical timing and predicting complications secondary to delayed definitive correction in non-critical long-bone fractures with Injury Severity Score <16.
Read the detailed description
Trauma is among the leading causes of death, disability, and hospitalizations each year worldwide. The majority of traumatic injuries are orthopedic in nature, making up nearly one million hospital encounters each year. According to the Center for Disease Control and Prevention, fractures are among the top 20 first-line diagnosis presenting to the emergency department. In recent years, the epidemiology of long bone fractures has been changing, with an increased incidence of fragility fractures in the elderly and high energy injuries affecting young adults. Fall-related fractures account for 61% of emergency orthopedic surgical procedures. Management of these orthopedic fractures is complex, and certain predictors such as lactate have been suggested to play a role in outcomes.
In the setting of trauma, the metabolic response of insufficient tissue perfusion is anaerobic glycolysis, with serum lactate as the final byproduct. Serum lactate serves as a circulating biomarker for organ oxygen supply and demand mismatch and is often used as a surrogate for tissue hypoxia. Normal blood lactate levels range from 0.5 to 2.2 mmol/L, with some variability in the upper limitation. Studies show early lactate clearance may be an important and independent prognostic variable in guiding management protocol for the resuscitation of trauma patients. Furthermore, several studies have presented more evidence that lactate levels can be considered a sensitive marker for patients in shock and during resuscitation with strong correlation with morbidity and mortality levels.
The goal of this study is to further investigate the role of serum lactate levels in guiding surgical timing and complications resulting from delay to the definitive surgical intervention in noncritical, traumatic patients with sustained long bone fractures.
- Being tested
- Orthopedic Surgery
- Medical subject headings
- Hyperlactatemia, Wounds, Nonpenetrating, Compassion Fatigue, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthopedic SurgeryProcedure or surgery
A complete retrospective chart review was performed for all the patients' records and included all patients aged 18 years or higher who presented to Arrowhead Regional Medical Center with long bone fractures with Injury Severity Score <16 and their repair and lactate levels at the time of surgery
| Study group | Role | What they receive |
|---|---|---|
| Lactate Level Under 2 mmol/L | Patients with a lactate level below 2 Receives: Procedure: Orthopedic Surgery | |
| Lactate Level Over 2 mmol/L | Patients with a lactate level above 2 Receives: Procedure: Orthopedic Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative lactate levels
Preoperative lactate levels were defined as the first measured lactate level on admission of an individual who presented as a trauma patient.
Measured: The estimated period of time over which preoperative lactate levels are measured occur in the initial 2 hours aft
Time to surgery from admission
The time that elapsed from admission to the hospital until surgery occurred
Measured: Time to surgery from admission in the hospital is defined as the event until initial orthopedic surgery occurred after admission. The time frame of measurement was 28 days until the event occurred.
Intraoperative complications
Incidence of known adverse events associated with orthopedic operation
Measured: 28 days
Length of total hospital stay
The time spent hospitalized in days.
Measured: Length of total hospital stay from admission in the hospital is defined as the time frame between admission and discharge. The time frame of collection until the event occurred was 180 days.
Discharge disposition
Once discharge was initiated did the individual get discharged home, skilled nursing facility, acute care facility.
Measured: Time frame of collection until the event occurred was 180 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start1 Jan 2021
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lactate Blood IncreaseStudies 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
- Retrospective
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arrowhead Regional Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aldin Malkoc, MD, Study chair, Arrowhead Regional Medical CenterMichael Neeki, DO, Principal investigator, Arrowhead Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05611398
- Sponsor's protocol ID
- 19-51
- Status last verified
- Nov 2022
- First submitted
- 26 Oct 2022
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jarman MP, Weaver MJ, Haider AH, Salim A, Harris MB. The National Burden of Orthopedic Injury: Cross-Sectional Estimates for Trauma System Planning and Optimization. J Surg Res. 2020 May;249:197-204. doi: 10.1016/j.jss.2019.12.023. Epub 2020 Jan 25.
PubMed 31991329Frouzan A, Masoumi K, Delirroyfard A, Mazdaie B, Bagherzadegan E. Diagnostic accuracy of ultrasound in upper and lower extremity long bone fractures of emergency department trauma patients. Electron Physician. 2017 Aug 1;9(8):5092-5097. doi: 10.19082/5092. eCollection 2017 Aug.
PubMed 28979747Ekegren CL, Edwards ER, de Steiger R, Gabbe BJ. Incidence, Costs and Predictors of Non-Union, Delayed Union and Mal-Union Following Long Bone Fracture. Int J Environ Res Public Health. 2018 Dec 13;15(12):2845. doi: 10.3390/ijerph15122845.
PubMed 30551632Bakker J, Gris P, Coffernils M, Kahn RJ, Vincent JL. Serial blood lactate levels can predict the development of multiple organ failure following septic shock. Am J Surg. 1996 Feb;171(2):221-6. doi: 10.1016/S0002-9610(97)89552-9.
PubMed 8619454