An observational study in Lactate Blood Increase, Trauma Blunt and Trauma, Secondary, sponsored by Arrowhead Regional Medical Center. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2022-11-10.
Sponsored by Arrowhead Regional Medical Center · Observational
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.
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.
50 studies on the registry are indexed under Hyperlactatemia; 7 are open to participants now.
This study's enrollment of 164 is above the median of 136 across 17 observational studies indexed under Hyperlactatemia.
Browse Hyperlactatemia studies →Arrowhead Regional Medical Center is the lead sponsor of 15 studies on the registry; 1 is open to participants now.
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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.
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Exclusion Criteria:
Patients with a lactate level below 2
Procedure: Orthopedic Surgery
Patients with a lactate level above 2
Procedure: 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
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.
Time frame: 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
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.
Intraoperative complications
Incidence of known adverse events associated with orthopedic operation
Time frame: 28 days
Length of total hospital stay
The time spent hospitalized in days.
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.
Discharge disposition
Once discharge was initiated did the individual get discharged home, skilled nursing facility, acute care facility.
Time frame: Time frame of collection until the event occurred was 180 days.
Plan to share: No
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Arrowhead Regional Medical Center