Outcome of Patients With Thoraco-abdominal Injury and Stress-induced Hyperglycemia or Diabetic Hyperglycemia

August 13, 2019 updated by: Chang Gung Memorial Hospital

Admission Hyperglycemia in Patients With Moderate to Severe Thoracoabdominal Injuries is Associated With Higher Mortality Rate Than Non-Diabetic Normoglycemic Patients

This study aimed to measure the effects of SIH and DH on the mortality outcomes of the adult patients with moderate to severe thoracoabdominal injury

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Because the pathophysiologic response of the patients with a thoracoabdominal injury is different from those who had a traumatic brain injury, this study aimed to measure the effects of hyperglycemia induced by stress or by diabetes on the outcomes of patients with thoracoabdominal injuries in comparison with those who had non-diabetic normoglycemia (NDN). The primary study hypothesis stated that, following thoracoabdominal injuries, the patients with SIH had a worse outcome than patients with DH. The primary outcome was mortality rate of these patients.

Study Type

Observational

Enrollment (Actual)

802

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 83301
        • Kaohsiung Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

This retrospective study reviewed data from trauma patients registered between January 1, 2009 and December 31, 2018. The inclusion criteria were age ≥20 years Adult patients with moderate to severe thoracoabdominal injuries (n = 802) were grouped into four exclusive subgroups: (1) SIH, which was defined as a serum glucose ≥ 200 mg/dL in the patients without DM (n = 52); (2) DH, which indicated a serum glucose ≥ 200 mg/dL in patients with DM (n = 79); (3), DN, which was defined when there was a serum glucose < 200 mg/dL in the patients with DM (n = 50); and (4) NDN, indicating a serum glucose < 200 mg/dL in patients who were absent of DM (n = 621)

Description

Inclusion Criteria:

  • adult patients with moderate to severe thoracoabdominal injuries

Exclusion Criteria:

  • patients with a thoracic and abdominal abbreviated injury scale (AIS) < 3
  • patients who had polytrauma which was defined as there was additional AIS scores ≥ 3 points in other regions of the body
  • patients less than 20 years old
  • patients who had sustained a burn injury

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
adult patients with thoracoabdominal injuries
adult patients with moderate to severe thoracoabdominal injuries
Other: Stress-induced hyperglycemia
Stress-induced hyperglycemia (SIH)was defined as a serum glucose ≥ 200 mg/dL in the patients without Diabetes mellitus.
Other: Diabetic hyperglycemia
Diabetic hyperglycemia (DH) which indicated a serum glucose ≥ 200 mg/dL in patients with Diabetes mellitus.
Other: Diabetic normoglycemia
Diabetic normoglycemia (DN), which was defined when there was a serum glucose < 200 mg/dL in the patients with Diabetes mellitus.
Other: Non-diabetic normoglycemia
Non-diabetic normoglycemia (NDN) indicating a serum glucose < 200 mg/dL in patients who were absent of Diabetes mellitus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
in-hospital mortality
Time Frame: up to 6 months
The primary outcome of the study was in-hospital mortality.
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Study Chair: TSANG-TANG Hsieh, Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 3, 2019

Primary Completion (ACTUAL)

July 1, 2019

Study Completion (ACTUAL)

August 9, 2019

Study Registration Dates

First Submitted

August 13, 2019

First Submitted That Met QC Criteria

August 13, 2019

First Posted (ACTUAL)

August 15, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 15, 2019

Last Update Submitted That Met QC Criteria

August 13, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201900726B0

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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