NCT04058015

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
802

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 3, 2019

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2019

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2019

Completed
Last Updated

August 15, 2019

Status Verified

June 1, 2019

Enrollment Period

28 days

First QC Date

August 13, 2019

Last Update Submit

August 13, 2019

Conditions

Keywords

admission hyperglycemiastress-induced hyperglycemiadiabetic hyperglycemiadiabetes mellitusthoracoabdominal traumamortality

Outcome Measures

Primary Outcomes (1)

  • in-hospital mortality

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

    up to 6 months

Study Arms (1)

adult patients with thoracoabdominal injuries

adult patients with moderate to severe thoracoabdominal injuries

Other: Stress-induced hyperglycemiaOther: Diabetic hyperglycemiaOther: Diabetic normoglycemiaOther: Non-diabetic normoglycemia

Interventions

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

adult patients with thoracoabdominal injuries

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

adult patients with thoracoabdominal injuries

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

adult patients with thoracoabdominal injuries

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

adult patients with thoracoabdominal injuries

Eligibility Criteria

Age20 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This retrospective study reviewed data from trauma patients registered between January 1, 2009 and December 31, 2018. The inclusion criteria were age ≥20 years Adult patients with moderate to severe thoracoabdominal injuries (n = 802) were grouped into four exclusive subgroups: (1) SIH, which was defined as a serum glucose ≥ 200 mg/dL in the patients without DM (n = 52); (2) DH, which indicated a serum glucose ≥ 200 mg/dL in patients with DM (n = 79); (3), DN, which was defined when there was a serum glucose \< 200 mg/dL in the patients with DM (n = 50); and (4) NDN, indicating a serum glucose \< 200 mg/dL in patients who were absent of DM (n = 621)

You may qualify if:

  • adult patients with moderate to severe thoracoabdominal injuries

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

Location

MeSH Terms

Conditions

Abdominal InjuriesThoracic InjuriesHyperglycemiaDiabetes Mellitus

Condition Hierarchy (Ancestors)

Wounds and InjuriesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • TSANG-TANG Hsieh

    Chang Gung Memorial Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2019

First Posted

August 15, 2019

Study Start

June 3, 2019

Primary Completion

July 1, 2019

Study Completion

August 9, 2019

Last Updated

August 15, 2019

Record last verified: 2019-06

Locations