Abdominal InjuryNCT04058015
Outcome of Patients With Thoraco-abdominal Injury and Stress-induced Hyperglycemia or Diabetic Hyperglycemia
An observational study of Abdominal Injury and Thoracic Injury, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Abdominal Injury, Thoracic Injury, Hyperglycemia
- What is being tested?
- Stress-induced hyperglycemia, Diabetic hyperglycemia and Diabetic normoglycemia
- How many people
- 802 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Jun 2019to 9 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- adult patients with moderate to severe thoracoabdominal injuries
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Admission Hyperglycemia in Patients With Moderate to Severe Thoracoabdominal Injuries is Associated With Higher Mortality Rate Than Non-Diabetic Normoglycemic Patients
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
Read the 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.
- Conditions
- Abdominal Injury, Thoracic Injury, Hyperglycemia, Hyperglycemia Stress
- Being tested
- Stress-induced hyperglycemia, Diabetic hyperglycemia, Diabetic normoglycemia, Non-diabetic normoglycemia
- Keywords
- admission hyperglycemia, stress-induced hyperglycemia, diabetic hyperglycemia, diabetes mellitus, thoracoabdominal trauma, mortality
- Medical subject headings
- Abdominal Injuries, Thoracic Injuries, Hyperglycemia, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress-induced hyperglycemiaOther
Stress-induced hyperglycemia (SIH)was defined as a serum glucose ≥ 200 mg/dL in the patients without Diabetes mellitus.
Diabetic hyperglycemiaOther
Diabetic hyperglycemia (DH) which indicated a serum glucose ≥ 200 mg/dL in patients with Diabetes mellitus.
Diabetic normoglycemiaOther
Diabetic normoglycemia (DN), which was defined when there was a serum glucose < 200 mg/dL in the patients with Diabetes mellitus.
Non-diabetic normoglycemiaOther
Non-diabetic normoglycemia (NDN) indicating a serum glucose < 200 mg/dL in patients who were absent of Diabetes mellitus.
| Study group | Role | What they receive |
|---|---|---|
| adult patients with thoracoabdominal injuries | adult patients with moderate to severe thoracoabdominal injuries Receives: Other: Stress-induced hyperglycemia; Other: Diabetic hyperglycemia; Other: Diabetic normoglycemia; Other: Non-diabetic normoglycemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
in-hospital mortality
The primary outcome of the study was in-hospital mortality.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start3 Jun 2019
- Primary completion1 Jul 2019
- Study completion9 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal InjuryStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 802 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- TSANG-TANG Hsieh, Study chair, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04058015
- Sponsor's protocol ID
- 201900726B0
- Status last verified
- Jun 2019
- First submitted
- 13 Aug 2019
- Last updated
- 15 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Admission Hyperglycemia in Patients With Moderate to Severe Thoracoabdominal Injuries is Associated With Higher Mortality Rate Than Non-Diabetic Normoglycemic Patients
- ClinicalTrials.gov ID
- NCT04058015
- Acronym / sponsor ID
- 201900726B0
- Conditions
- Abdominal Injury, Thoracic Injury, Hyperglycemia, Hyperglycemia Stress
- Keywords
- admission hyperglycemia, stress-induced hyperglycemia, diabetic hyperglycemia, diabetes mellitus, thoracoabdominal trauma, mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 802 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 9 Aug 2019 (actual)
- First posted
- 15 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adult patients with thoracoabdominal injuries | – | Other: Stress-induced hyperglycemia, Other: Diabetic hyperglycemia, Other: Diabetic normoglycemia, Other: Non-diabetic normoglycemiaadult patients with moderate to severe thoracoabdominal injuries |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (1 listed)
- adult patients with moderate to severe thoracoabdominal injuries
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stress-induced hyperglycemiaStress-induced hyperglycemia (SIH)was defined as a serum glucose ≥ 200 mg/dL in the patients without Diabetes mellitus. | Other | adult patients with thoracoabdominal injuries |
| Diabetic hyperglycemiaDiabetic hyperglycemia (DH) which indicated a serum glucose ≥ 200 mg/dL in patients with Diabetes mellitus. | Other | adult patients with thoracoabdominal injuries |
| Diabetic normoglycemiaDiabetic normoglycemia (DN), which was defined when there was a serum glucose < 200 mg/dL in the patients with Diabetes mellitus. | Other | adult patients with thoracoabdominal injuries |
| Non-diabetic normoglycemiaNon-diabetic normoglycemia (NDN) indicating a serum glucose < 200 mg/dL in patients who were absent of Diabetes mellitus. | Other | adult patients with thoracoabdominal injuries |
Primary outcome
in-hospital mortality
Time frame: up to 6 months
The primary outcome of the study was in-hospital mortality.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
TSANG-TANG Hsieh study chair
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Injury and Thoracic Injury, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
in-hospital mortality (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2019.