Lactate Monitoring in Traumatic Long Bone Fractures Requiring Emergent Surgical Intervention

NCT ID: NCT05611398

Last Updated: 2022-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

164 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-01-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lactate Blood Increase Trauma Blunt Trauma, Secondary Injury Traumatic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Lactate Level Under 2 mmol/L

Patients with a lactate level below 2

Orthopedic Surgery

Intervention Type PROCEDURE

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

Lactate Level Over 2 mmol/L

Patients with a lactate level above 2

Orthopedic Surgery

Intervention Type PROCEDURE

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

Interventions

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Orthopedic 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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* All patients aged 18 years or higher with long bone fractures with Injury Severity Score \<16

Exclusion Criteria

* 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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arrowhead Regional Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aldin Malkoc, MD

Role: STUDY_CHAIR

Arrowhead Regional Medical Center

Michael Neeki, DO

Role: PRINCIPAL_INVESTIGATOR

Arrowhead Regional Medical Center

Locations

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Arrowhead Regional Medical Center

Colton, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 31991329 (View on PubMed)

Frouzan 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.

Reference Type BACKGROUND
PMID: 28979747 (View on PubMed)

Ekegren 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.

Reference Type BACKGROUND
PMID: 30551632 (View on PubMed)

Bakker 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.

Reference Type BACKGROUND
PMID: 8619454 (View on PubMed)

Other Identifiers

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19-51

Identifier Type: -

Identifier Source: org_study_id

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