Predicting multiple organ shutdown after major injury in the emergency setting
| ISRCTN | ISRCTN16661943 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16661943 |
| Protocol serial number | N/A |
| Sponsor | Sam Ratulangi University |
| Funder | Investigator initiated and funded |
- Submission date
- 26/07/2016
- Registration date
- 09/11/2016
- Last edited
- 28/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English summary of protocol
Background and study aims
Major trauma accounts for a significant number of deaths worldwide, and is one of the most frequent causes of death in people under the age of 40. When a person sustains trauma (injury) to multiple parts of the body (multitrauma) they are at risk of their organs shutting down if their condition is not managed effectively in hospital. Multiple organ dysfunction syndrome (MODS), is a serious condition where two or more organ systems stop working properly. Being able to identify a patient’s risk of developing MODS following multitrauma would be very beneficial and help improve the patient’s chance of survival. The aim of this study is to find out whether completing a number of standard medical assessments of multitrauma patients can help to predict their chance of developing MODS.
Who can participate?
Adults who have suffered from trauma in multiple body regions.
What does the study involve?
Mutlitrauma patients who have been admitted to the Emergency Department of a participating hospital are assessed by the research team. This involves taking blood samples, physically examining the patients and assessing the extent of their trauma. These assessments are repeated every 24 hours until the patient is discharged from hospital in order to find out if there is a link between the results of these tests and the development of MODS.
What are the possible benefits and risks of participating?
Participants benefit from having the possibility of them developing MODS being identified sooner so they can be treated sooner. There are no notable risks involved with participating.
Where is the study run from?
1. Department of surgery, Univeristy of Sam Ratulangi (Indonesia)
2. Department of surgery, University Diponegoro (Indonesia)
3. Departement of surgery, University Udayana (Indonesia)
4. Departement of surgery, University Hasanuddin (Indonesia)
When is the study starting and how long is it expected to run for?
September 2014 to December 2015
Who is funding the study?
Investigator initiated and funded (Indonesia)
Who is the main contact?
Dr Leo Rendy
dept@rskandou.com
Contact information
Scientific
Sam Ratulangi University
Department of surgery
Gedung bedah swadana
Jl. Raya Tanawangko 56
Malalayang 1
Manado
16161
Indonesia
 ORCID ID |
0000-0003-2485-6017 |
|---|---|
| Phone | +662 431 3469191 |
| dept@rskandou.com |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Multi-centre cohort study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Multiple organ dysfunction syndrome (MODS) prediction score in multitrauma patients |
| Study objectives | Injury severity score, revised trauma score, shock, hemoglobin, white blood cells, platelet, and lactate level may predict the occurrence of multiple organ dysfunction syndrome after multitrauma. |
| Ethics approval(s) | Ethical board of Kandou hospital, ref: 076/EC-UPKT/VII/2015 |
| Health condition(s) or problem(s) studied | Multiple organ dysfunction syndrome |
| Intervention | New trauma patients admitted to the emergency department of a participating hospital undergo a range of assessments. This involves: 1. Having extra blood samples taken when they undergo blood tests as part of standard care so that the researchers can measure lactate level, blood cell count, and blood gas analysis 2. Undergoing a primary trauma assessment, which involves evaluation of airway, breathing, and circulation (pulse rate, oxygen saturation, blood pressure), disability (mental status whether alert, pain response, verbal response, or no response), and exposure (release clothes and jewelry, exposure of injured area, having been given a blanket to prevent hypothermia). 3. RTS (revised trauma score) and ISS (Injury severity scale) determined, which involves assessing heart rate, respiratory rate, and Glasgow coma scale and an adjuct examination to precisely determine degree of injury in 6 body regions. Every 24 hours until patients are discharged from hospital, their physical function is assessed through clinical observations (heart rate, urine output, level of consciousness) and further blood samples are taken, looking for signs of MODS development until discharge from hospital. |
| Intervention type | Not Specified |
| Primary outcome measure(s) |
Multiple organ dysfunction syndrome (MODS) incidence is measured using sequential organ failure assessment (SOFA) scoring system every day until patients discharged from hospital. |
| Key secondary outcome measure(s) |
Mortality is measured during hospitalization and 6 month follow up. |
| Completion date | 01/12/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 100 |
| Key inclusion criteria | 1. Age between 16 and 65 years old 2. Multitrauma patients (trauma in multiple body regions) 3. Injury severity score (ISS) ≥16 4. No chronic illness as comorbidities, no previous major trauma with or without surgery |
| Key exclusion criteria | 1. Minor trauma 2. Previous major trauma |
| Date of first enrolment | 01/11/2014 |
| Date of final enrolment | 01/10/2015 |
Locations
Countries of recruitment
- Indonesia
Study participating centres
Gedung Bedah swadana RSUP Kandou
Manado
95115
Indonesia
Jl. Dr. Soetomo 18
Jawa Tengah
50271
Indonesia
Denpasar
Bali
80114
Indonesia
Tamalanrea Indah
Makassar
Kota Makassar
Sulawesi Selatan
90245
Indonesia
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2017 | 28/01/2019 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
28/01/2019: Publication reference added
