Lactate Monitoring in Traumatic Long Bone Fractures Requiring Emergent Surgical Intervention

NCT05611398 | Completed

• 1 other identifier: 19-51
• Study Type: observational
• Target: 164
• Locations: 1 country
• Sites: 1

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.

Conditions

Lactate Blood Increase; Trauma Blunt; Trauma, Secondary; Injury Traumatic

Outcome Measures

Primary Outcomes (5)

• 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.

  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 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

  28 days

• Length of total hospital stay

  The time spent hospitalized in days.

  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 of collection until the event occurred was 180 days.

Study Arms (2)

Lactate Level Under 2 mmol/L

Patients with a lactate level below 2

Procedure: Orthopedic Surgery

Lactate Level Over 2 mmol/L

Patients with a lactate level above 2

Procedure: Orthopedic Surgery

Interventions

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

Lactate Level Over 2 mmol/L; Lactate Level Under 2 mmol/L

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arrowhead Regional Medical Center: lead

Study Sites (1)

Arrowhead Regional Medical Center

Colton, California, 92324, United States

Location

Related Publications (4)

• 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.

  PMID: 31991329 BACKGROUND

• 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.

  PMID: 28979747 BACKGROUND

• 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.

  PMID: 30551632 BACKGROUND

• 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.

  PMID: 8619454 BACKGROUND

MeSH Terms

Conditions

Hyperlactatemia; Wounds, Nonpenetrating; Compassion Fatigue; Wounds and Injuries

Interventions

Orthopedic Procedures

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Fatigue; Fatigue; Behavioral Symptoms; Behavior; Occupational Stress; Stress, Psychological

Intervention Hierarchy (Ancestors)

Therapeutics; Surgical Procedures, Operative

Study Officials

• Aldin Malkoc, MD

  Arrowhead Regional Medical Center

  STUDY CHAIR

• Michael Neeki, DO

  Arrowhead Regional Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: November 10, 2022
• Study Start: January 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: November 10, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)