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

Hyperglycemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04058015
• Other study ID #: 201900726B0
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Abdominal Injuries
• Abdominal Injury
• Hyperglycemia
• Hyperglycemia Stress
• Thoracic Injuries
• Thoracic Injury
• Wounds and Injuries

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