Condition category
Signs and Symptoms
Date applied
26/07/2016
Date assigned
09/11/2016
Last edited
11/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Leo Rendy

ORCID ID

http://orcid.org/0000-0003-2485-6017

Contact details

Sam Ratulangi University
Department of surgery
Gedung bedah swadana
Jl. Raya Tanawangko 56
Malalayang 1
Manado
16161
Indonesia
+662 431 3469191
dept@rskandou.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Multiple organ dysfunction syndrome (MODS) prediction score in multitrauma patients

Acronym

Study hypothesis

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

Ethical board of Kandou hospital, ref: 076/EC-UPKT/VII/2015

Study design

Multi-centre cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

Multiple organ dysfunction syndrome (MODS) incidence is measured using sequential organ failure assessment (SOFA) scoring system every day until patients discharged from hospital.

Secondary outcome measures

Mortality is measured during hospitalization and 6 month follow up.

Overall trial start date

01/09/2014

Overall trial end date

01/12/2015

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Minor trauma
2. Previous major trauma

Recruitment start date

01/11/2014

Recruitment end date

01/10/2015

Locations

Countries of recruitment

Indonesia

Trial participating centre

Department of surgery, Univeristy of Sam Ratulangi
Jl. Raya Tanawangko Gedung Bedah swadana RSUP Kandou
Manado
95115
Indonesia

Trial participating centre

Department of surgery, University Diponegoro
Fakultas Kedokteran Universitas Diponegoro (UNDIP) Jl. Dr. Soetomo 18
Jawa Tengah
50271
Indonesia

Trial participating centre

Departement of surgery, University Udayana
Jl. Kesehatan no.1 Denpasar
Bali
80114
Indonesia

Trial participating centre

Departement of surgery, University Hasanuddin
Jl. Perintis Kemerdekaan KM. 10 Tamalanrea Indah Makassar Kota Makassar
Sulawesi Selatan
90245
Indonesia

Sponsor information

Organisation

Sam Ratulangi University

Sponsor details

Kandou General Hospital
Departement of Surgery
Jl. raya tanawangko
Manado
95115
Indonesia
+624313469191
mail@rskandou.com

Sponsor type

University/education

Website

http://faked.unsrat.ac.id/psilbedah

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in high impact trauma or surgery journals

Intention to publish date

01/12/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes