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

Completed

• Conditions: Abdominal Injury; Thoracic Injury; Hyperglycemia; Hyperglycemia Stress
• Interventions: Other: Stress-induced hyperglycemia; Other: Diabetic hyperglycemia; Other: Diabetic normoglycemia; Other: Non-diabetic normoglycemia

• Registration Number: NCT04058015
• Lead Sponsor: Chang Gung Memorial Hospital

Brief 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

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 Timeline

• Status Verified: 2019-06
• Study Start: 2019-06-03
• Primary Completion: 2019-07-01
• Study Completion: 2019-08-09
• Study First Submitted: 2019-08-13
• Study First Submitted QC: 2019-08-13
• Last Update Submitted: 2019-08-13
• Study First Posted: 2019-08-15
• Last Update Posted: 2019-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 802

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
adult patients with thoracoabdominal injuries	Diabetic hyperglycemia	adult patients with moderate to severe thoracoabdominal injuries
adult patients with thoracoabdominal injuries	Stress-induced hyperglycemia	adult patients with moderate to severe thoracoabdominal injuries
adult patients with thoracoabdominal injuries	Non-diabetic normoglycemia	adult patients with moderate to severe thoracoabdominal injuries
adult patients with thoracoabdominal injuries	Diabetic normoglycemia	adult patients with moderate to severe thoracoabdominal injuries

Primary Outcome Measures

Name	Time	Method
in-hospital mortality	up to 6 months	The primary outcome of the study was in-hospital mortality.

Trial Locations

Locations (1)

Kaohsiung Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan