Lactate Monitoring in Traumatic Long Bone Fractures Requiring Emergent Surgical Intervention

Completed

• Conditions: Injury Traumatic; Lactate Blood Increase; Trauma, Secondary; Trauma Blunt
• Interventions: Procedure: Orthopedic Surgery

• Registration Number: NCT05611398
• Lead Sponsor: Arrowhead Regional Medical Center

Brief 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. 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

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.

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2022-01-01
• Study Completion: 2022-01-01
• Study First Submitted: 2022-10-26
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-03
• Last Update Submitted: 2022-11-03
• Study First Posted: 2022-11-10
• Last Update Posted: 2022-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lactate Level Under 2 mmol/L	Orthopedic Surgery	Patients with a lactate level below 2
Lactate Level Over 2 mmol/L	Orthopedic Surgery	Patients with a lactate level above 2

Primary Outcome Measures

Name	Time	Method
Discharge disposition	Time frame of collection until the event occurred was 180 days.	Once discharge was initiated did the individual get discharged home, skilled nursing facility, acute care facility.
Intraoperative complications	28 days	Incidence of known adverse events associated with orthopedic operation
Length of total hospital stay	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.	The time spent hospitalized in days.
Preoperative lactate levels	The estimated period of time over which preoperative lactate levels are measured occur in the initial 2 hours aft	Preoperative lactate levels were defined as the first measured lactate level on admission of an individual who presented as a trauma patient.
Time to surgery from admission	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.	The time that elapsed from admission to the hospital until surgery occurred

Trial Locations

Locations (1)

Arrowhead Regional Medical Center; 🇺🇸 Colton, California, United States