Predicting multiple organ shutdown after major injury in the emergency setting

ISRCTN ISRCTN16661943
DOI https://doi.org/10.1186/ISRCTN16661943
Secondary identifying numbers N/A
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Dr Leo Rendy
Scientific

Sam Ratulangi University
Department of surgery
Gedung bedah swadana
Jl. Raya Tanawangko 56
Malalayang 1
Manado
16161
Indonesia

ORCiD logoORCID ID 0000-0003-2485-6017
Phone +662 431 3469191
Email dept@rskandou.com

Study information

Study designMulti-centre cohort study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeScreening
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleMultiple organ dysfunction syndrome (MODS) prediction score in multitrauma patients
Study objectivesInjury 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) studiedMultiple organ dysfunction syndrome
InterventionNew 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 typeNot Specified
Primary outcome measureMultiple organ dysfunction syndrome (MODS) incidence is measured using sequential organ failure assessment (SOFA) scoring system every day until patients discharged from hospital.
Secondary outcome measuresMortality is measured during hospitalization and 6 month follow up.
Overall study start date01/09/2014
Completion date01/12/2015

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants100
Key inclusion criteria1. 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 criteria1. Minor trauma
2. Previous major trauma
Date of first enrolment01/11/2014
Date of final enrolment01/10/2015

Locations

Countries of recruitment

  • Indonesia

Study participating centres

Department of surgery, Univeristy of Sam Ratulangi
Jl. Raya Tanawangko
Gedung Bedah swadana RSUP Kandou
Manado
95115
Indonesia
Department of surgery, University Diponegoro
Fakultas Kedokteran Universitas Diponegoro (UNDIP)
Jl. Dr. Soetomo 18
Jawa Tengah
50271
Indonesia
Departement of surgery, University Udayana
Jl. Kesehatan no.1
Denpasar
Bali
80114
Indonesia
Departement of surgery, University Hasanuddin
Jl. Perintis Kemerdekaan KM. 10
Tamalanrea Indah
Makassar
Kota Makassar
Sulawesi Selatan
90245
Indonesia

Sponsor information

Sam Ratulangi University
University/education

Kandou General Hospital
Departement of Surgery
Jl. raya tanawangko
Manado
95115
Indonesia

Phone +624313469191
Email mail@rskandou.com
Website http://faked.unsrat.ac.id/psilbedah
ROR logo "ROR" https://ror.org/01cn6ph21

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date01/12/2016
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in high impact trauma or surgery journals
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

Editorial Notes

28/01/2019: Publication reference added