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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04058015
Other study ID # 201900726B0
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 3, 2019
Est. completion date August 9, 2019

Study information

Verified date June 2019
Source Chang Gung Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 802
Est. completion date August 9, 2019
Est. primary completion date July 1, 2019
Accepts healthy volunteers No
Gender All
Age group 20 Years to 100 Years
Eligibility 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 Design


Intervention

Other:
Stress-induced hyperglycemia
Stress-induced hyperglycemia (SIH)was defined as a serum glucose = 200 mg/dL in the patients without Diabetes mellitus.
Diabetic hyperglycemia
Diabetic hyperglycemia (DH) which indicated a serum glucose = 200 mg/dL in patients with Diabetes mellitus.
Diabetic normoglycemia
Diabetic normoglycemia (DN), which was defined when there was a serum glucose < 200 mg/dL in the patients with Diabetes mellitus.
Non-diabetic normoglycemia
Non-diabetic normoglycemia (NDN) indicating a serum glucose < 200 mg/dL in patients who were absent of Diabetes mellitus.

Locations

Country Name City State
Taiwan Kaohsiung Chang Gung Memorial Hospital Kaohsiung

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary in-hospital mortality The primary outcome of the study was in-hospital mortality. up to 6 months
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