TraumaNCT05549986
Discriminant Ability of the Shock Index, Modified Shock Index, and Reverse Shock Index Multiplied by the Glasgow Coma Scale on Mortality in Adult Trauma Patients: A PATOS Study
An observational study of Trauma and Shock, Traumatic, run by Mackay Memorial Hospital.
Trial summary
We evaluated a cohort of adult trauma patients transported to emergency departments. The first vital signs were used to calculate the SI, MSI, and rSIG. The areas under the receiver operating characteristic curves (AUROCs) and test results were used to compare the discriminant performance of the indices on short-term… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Trauma, Shock, Traumatic, Morality
- What is being tested?
- Observational
- How many people
- 105,641 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 31 Dec 2020
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study included adult patients (≥18 years) EMS-transported from January 2016 to December 2020. Patients with missing entries of age, sex, triage, SBP, DBP, HR, or GCS were excluded. Entries with missing records of in-hospital mortality or 30-day mortality were excluded from the short-term mortality cohort analyses. Patients without a Modified Rankin Scale (MRS) record at discharge were excluded from the functional outcome cohort analyses.
Who may be able to join
- Adult patients (≥18 years) EMS-transported from January 2016 to December 2020
Who cannot join
- Patients with missing entries of age, sex, triage, SBP, DBP, HR, or GCS were excluded.
- Entries with missing records of in-hospital mortality or 30-day mortality were excluded from the short-term mortality cohort analyses.
- Patients without a Modified Rankin Scale (MRS) record at discharge were excluded from the functional outcome cohort analyses.
About this study
We evaluated a cohort of adult trauma patients transported to emergency departments. The first vital signs were used to calculate the SI, MSI, and rSIG. The areas under the receiver operating characteristic curves (AUROCs) and test results were used to compare the discriminant performance of the indices on short-term mortality and poor functional outcome. A subgroup analysis of geriatric patients, traumatic brain injury, penetrating injury, and non-penetrating injury was performed.
- Conditions
- Trauma, Shock, Traumatic, Morality
- Being tested
- Observational
- Keywords
- Shock index(SI), Modified Shock Index (MSI), Reverse Shock Index Multiplied by the Glasgow Coma Scale (rSIG), Mortality, Pan-Asian Trauma Outcomes Study (PATOS)
- Medical subject headings
- Wounds and Injuries, Shock, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Observational
| Study group | Role | What they receive |
|---|---|---|
| Mortality group | Patients encountered in-hospital mortality or 30-day mortality Receives: Other: Observational | |
| Survival group | Patients did not encounter in-hospital mortality or 30-day mortality Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discriminant power of SI, MSI, and rSIG on short-term mortality for adult traumatic patients
AUROC in associated with short-term mortality with SI, MSI, rSIG
Measured: 30 days
Secondary outcomes (1)
Discriminant power of SI, MSI, and rSIG on functional outcome for adult traumatic patients
AUROC in associated with functional outcome with SI, MSI, rSIG
Measured: We defined no symptoms, no significant disability, slight disability, and moderate disability (MRS 0-3) as favorable functional outcomes and moderately severe disability, severe disability, and death (MRS 4-6) as poor functional outcomes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start1 Jan 2016
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TraumaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 105,641 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tse-Hao Chen, Mackay Memorial Hospital
- Investigators
- Tse-Hao Chen, M.D., Principal investigator, Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05549986
- Sponsor's protocol ID
- 21MMHIS389e
- Status last verified
- Sep 2022
- First submitted
- 29 Aug 2022
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen TH, Wu MY, Do Shin S, Jamaluddin SF, Son DN, Hong KJ, Jen-Tang S, Tanaka H, Hsiao CH, Hsieh SL, Chien DK, Tsai W, Chang WH, Chiang WC; PATOS Clinical Research Network. Discriminant ability of the shock index, modified shock index, and reverse shock index multiplied by the Glasgow coma scale on mortality in adult trauma patients: a PATOS retrospective cohort study. Int J Surg. 2023 May 1;109(5):1231-1238. doi: 10.1097/JS9.0000000000000287.
PubMed 37222717
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discriminant Ability of the Shock Index, Modified Shock Index, and Reverse Shock Index Multiplied by the Glasgow Coma Scale on Mortality in Adult Trauma Patients: A PATOS Study
- ClinicalTrials.gov ID
- NCT05549986
- Acronym / sponsor ID
- 21MMHIS389e
- Conditions
- Trauma, Shock, Traumatic, Morality
- Keywords
- Shock index(SI), Modified Shock Index (MSI), Reverse Shock Index Multiplied by the Glasgow Coma Scale (rSIG), Mortality, Pan-Asian Trauma Outcomes Study (PATOS)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105,641 participants (actual)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 22 Sep 2022 (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.
We evaluated a cohort of adult trauma patients transported to emergency departments. The first vital signs were used to calculate the SI, MSI, and rSIG. The areas under the receiver operating characteristic curves (AUROCs) and test results were used to compare the discriminant performance of the indices on short-term mortality and poor functional outcome. A subgroup analysis of geriatric patients, traumatic brain injury, penetrating injury, and non-penetrating injury was performed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mortality group | – | Other: ObservationalPatients encountered in-hospital mortality or 30-day mortality |
| Survival group | – | Other: ObservationalPatients did not encounter in-hospital mortality or 30-day mortality |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study included adult patients (≥18 years) EMS-transported from January 2016 to December 2020. Patients with missing entries of age, sex, triage, SBP, DBP, HR, or GCS were excluded. Entries with missing records of in-hospital mortality or 30-day mortality were excluded from the short-term mortality cohort analyses. Patients without a Modified Rankin Scale (MRS) record at discharge were excluded from the functional outcome cohort analyses.
Key inclusion criteria (1 listed)
- Adult patients (≥18 years) EMS-transported from January 2016 to December 2020
Key exclusion criteria (3 listed)
- Patients with missing entries of age, sex, triage, SBP, DBP, HR, or GCS were excluded.
- Entries with missing records of in-hospital mortality or 30-day mortality were excluded from the short-term mortality cohort analyses.
- Patients without a Modified Rankin Scale (MRS) record at discharge were excluded from the functional outcome cohort analyses.
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 |
|---|---|---|
| ObservationalObservational | Other | Mortality group, Survival group |
Primary outcome
Discriminant power of SI, MSI, and rSIG on short-term mortality for adult traumatic patients
Time frame: 30 days
AUROC in associated with short-term mortality with SI, MSI, rSIG
1 secondary outcome
Discriminant power of SI, MSI, and rSIG on functional outcome for adult traumatic patients
Time frame: We defined no symptoms, no significant disability, slight disability, and moderate disability (MRS 0-3) as favorable functional outcomes and moderately severe disability, severe disability, and death (MRS 4-6) as poor functional outcomes
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 22 Sep 2022.
- Derived from this study: PubMed 37222717Chen TH, Wu MY, Do Shin S, Jamaluddin SF, Son DN, Hong KJ, Jen-Tang S, Tanaka H, Hsiao CH, Hsieh SL, Chien DK, Tsai W, Chang WH, Chiang WC; PATOS Clinical Research Network. Discriminant ability of the shock index, modified shock index, and reverse shock index multiplied by the Glasgow coma scale on mortality in adult trauma patients: a PATOS retrospective cohort study. Int J Surg. 2023 May 1;109(5):1231-1238. doi: 10.1097/JS9.0000000000000287.
- Individual participant dataSharing planned: No
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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.
Tse-Hao Chen, M.D. principal investigator
Mackay Memorial Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma and Shock, Traumatic, run by Mackay Memorial Hospital.
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 3 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 22 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Discriminant power of SI, MSI, and rSIG on short-term mortality for adult traumatic patients (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05549986, which also lists 1 linked publication.
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 22 Sep 2022.