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

NCT ID: NCT04058015

Last Updated: 2019-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

802 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-03

Study Completion Date

2019-08-09

Brief Summary

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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

Detailed Description

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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.

Conditions

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Abdominal Injury Thoracic Injury Hyperglycemia Hyperglycemia Stress

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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adult patients with thoracoabdominal injuries

adult patients with moderate to severe thoracoabdominal injuries

Stress-induced hyperglycemia

Intervention Type OTHER

Stress-induced hyperglycemia (SIH)was defined as a serum glucose ≥ 200 mg/dL in the patients without Diabetes mellitus.

Diabetic hyperglycemia

Intervention Type OTHER

Diabetic hyperglycemia (DH) which indicated a serum glucose ≥ 200 mg/dL in patients with Diabetes mellitus.

Diabetic normoglycemia

Intervention Type OTHER

Diabetic normoglycemia (DN), which was defined when there was a serum glucose \< 200 mg/dL in the patients with Diabetes mellitus.

Non-diabetic normoglycemia

Intervention Type OTHER

Non-diabetic normoglycemia (NDN) indicating a serum glucose \< 200 mg/dL in patients who were absent of Diabetes mellitus.

Interventions

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Stress-induced hyperglycemia

Stress-induced hyperglycemia (SIH)was defined as a serum glucose ≥ 200 mg/dL in the patients without Diabetes mellitus.

Intervention Type OTHER

Diabetic hyperglycemia

Diabetic hyperglycemia (DH) which indicated a serum glucose ≥ 200 mg/dL in patients with Diabetes mellitus.

Intervention Type OTHER

Diabetic normoglycemia

Diabetic normoglycemia (DN), which was defined when there was a serum glucose \< 200 mg/dL in the patients with Diabetes mellitus.

Intervention Type OTHER

Non-diabetic normoglycemia

Non-diabetic normoglycemia (NDN) indicating a serum glucose \< 200 mg/dL in patients who were absent of Diabetes mellitus.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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TSANG-TANG Hsieh

Role: STUDY_CHAIR

Chang Gung Memorial Hospital

Locations

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Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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201900726B0

Identifier Type: -

Identifier Source: org_study_id

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