NCT04640701

Brief Summary

Obesity is a national epidemic that affects all aspects of health care, including trauma care. According to the Centers for Disease Control and Prevention, 1% of US adults 20 years old and older are obese (body mass index \[BMI\], calculated as weight in kilograms divided by height in meters squared, \> 30), and 69% are overweight (BMI \> 25) (1, 2). Obesity is a major health concern because of its established relationship with serious medical diseases and increased likelihood of comorbid conditions (eg, diabetes mellitus, hyperlipidemia, heart disease, pulmonary disease) (3). As the number of obese adults continues to increase, the potential number of obese trauma patients with severe injury and complications will also increase (3). Management of prehospital and in-hospital trauma care, including complications associated with airway management, surgical procedures, and radiological imaging, of obese patients can be challenging. However, published reports on how obesity complicates hospital stays after trauma are conflicting (4, 5). Several studies have indicated that obese trauma patients are more likely than non-obese patients to have longer stays in the intensive care unit (ICU) and hospital, more days of mechanical ventilation, more complications, and comorbid conditions, and higher mortality (6,7,8). Other studies have indicated no differences between obese and nonobese patients in mortality, length of stay in the ICU and the hospital, duration of mechanical ventilation, complications, or comorbid conditions (9). Accordingly, the main aim of this study is to investigate and compare hospital course, clinical outcomes, disposition, and the cost of treatment between geriatric obese and non-obese patients hospitalized for treatment of traumatic injuries.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 12, 2016

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2019

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

November 23, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 13, 2022

Completed
Last Updated

March 24, 2026

Status Verified

August 1, 2023

Enrollment Period

5.8 years

First QC Date

August 12, 2019

Last Update Submit

March 20, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Obesity's effect on the outcomes of geriatric trauma patients

    Type of Injury (length of stay)

    January1st 2006 and June 30th 2016

Secondary Outcomes (3)

  • Body mass index

    January1st 2006 and June 30th 2016

  • Length of stay

    January1st 2006 and June 30th 2016

  • Injury severity score

    January1st 2006 and June 30th 2016

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Records of trauma patients who were admitted to MHS between January1st 2006 and June 30th 2016

You may qualify if:

  • Male and female patient's ≥ 60 years of age.
  • Blunt and penetration injury.

You may not qualify if:

  • Pregnant and breastfeeding women.
  • Patients \< 60 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michael Truitt, M.D.

    The Methodist Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 12, 2019

First Posted

November 23, 2020

Study Start

July 12, 2016

Primary Completion

May 13, 2022

Study Completion

May 13, 2022

Last Updated

March 24, 2026

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations