Clinical Trials Directory

Trials / Completed

CompletedNCT05611398

Lactate Monitoring in Traumatic Long Bone Fractures Requiring Emergent Surgical Intervention

Analysis of Lactate Monitoring Requirement in Emergent Surgical Interventions in Noncritical Traumatic Long Bone Fractures

Status
Completed
Phase
Study type
Observational
Enrollment
164 (actual)
Sponsor
Arrowhead Regional Medical Center · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREOrthopedic SurgeryA 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

Timeline

Start date
2021-01-01
Primary completion
2022-01-01
Completion
2022-01-01
First posted
2022-11-10
Last updated
2022-11-10

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05611398. Inclusion in this directory is not an endorsement.