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Completed

NCT Number: NCT05611398

Lactate Monitoring in Traumatic Long Bone Fractures Requiring Emergent Surgical Intervention

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.

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Key information

Conditions

Lactate Blood Increase Behavior Behavioral Symptoms Compassion Fatigue Fatigue Hyperlactatemia Injury Traumatic Mental Fatigue Metabolic Diseases Nutritional and Metabolic Diseases Occupational Stress Pathological Conditions, Signs and Symptoms Signs and Symptoms Stress, Psychological Trauma Blunt Trauma, Secondary Wounds and Injuries Wounds, Nonpenetrating

Sex eligibility

All sexes

Study type

Observational

Primary location

Arrowhead Regional Medical Center

Colton, California, 92324, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

orthopedic surgery

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

Primary outcomes

  1. Preoperative lactate levels

    Time frame: 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.

  2. Time to surgery from admission

    Time frame: 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

  3. Intraoperative complications

    Time frame: 28 days

    Incidence of known adverse events associated with orthopedic operation

  4. Length of total hospital stay

    Time frame: 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.

  5. Discharge disposition

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Arrowhead Regional Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 10, 2022
Registry last updated
Nov 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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