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Completed

NCT Number: NCT04058015

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

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

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Key information

Conditions

Abdominal Injury Abdominal Injuries Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperglycemia Hyperglycemia Stress Metabolic Diseases Nutritional and Metabolic Diseases Thoracic Injuries Thoracic Injury Wounds and Injuries

Age range

20 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stress-induced hyperglycemia

Other

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

Diabetic hyperglycemia

Other

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

Diabetic normoglycemia

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

Other

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

Primary outcomes

  1. in-hospital mortality

    Time frame: up to 6 months

    The primary outcome of the study was in-hospital mortality.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 15, 2019
Registry last updated
Aug 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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