Condition category
Injury, Occupational Diseases, Poisoning
Date applied
15/06/2009
Date assigned
24/07/2009
Last edited
17/12/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 2

Trial website

Contact information

Type

Scientific

Primary contact

Prof Michael James

ORCID ID

Contact details

Department of Anaesthesia
University of Cape Town
Anzio Road
Observatory
Western Cape
Cape Town
7925
South Africa
+27 (0)21 406 6143
mike.james@uct.ac.za

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Comparison of crystalloid-blood resuscitation with crystalloid-colloid-blood resuscitation in severe trauma patients: a randomised double-blind trial

Acronym

FIRST (Fluids In Resuscitation of Severe Trauma)

Study hypothesis

Colloid (hydroxyethyl starch HES 130/0.4 in saline) used for trauma resuscitation is superior to crystalloid (0.9% saline) solutions in terms of volumes required for resuscitation and consequent morbidity, particularly the recovery of gastrointestinal function and the incidence of complications.

Ethics approval

University of Cape Town Research Ethics Committee approved on the 23rd January 2007 (ref: 217/2006)

Study design

Randomised single centre double-blind interventional study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Available in English/Afrikaans/Xhosa from mike.james@uct.ac.za

Condition

Severe blunt or penetrating trauma

Intervention

1. Intravenous fluid administration to haemodynamic and physiological endpoints as required, 0.9% saline
2. HES 130/0.4 in saline (VoluvenĀ®)
Time taken to achieve haemodynamic goals is recorded. Duration of treatment is until study endpoint (return of bowel function) is satisfied; follow-up for 30 days from enrolment or death.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Volumes of fluids required to meet resuscitation goals over the first 24 hours from study entry
2. Time (days) until recovery of bowel function as determined by tolerance of oral of parenteral feeding

Secondary outcome measures

1. Days free of gastrointestinal dysfunction during first 30 days
2. Median and maximal sequential organ failure assessment (SOFA) score
3. Length of stay in Intensive Care Unit (LOS in ICU)
4. Fluid volumes used during initial surgical procedures
5. Time to initial achievement of resuscitation target values
6. Intra-abdominal pressure following resuscitation
7. Time to first passage of stool

Overall trial start date

06/12/2007

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients suffering severe trauma requiring at least 3 litres of estimated resuscitation fluid admitted to Groote Shuur Hospital Trauma Unit
2. Penetrating or blunt trauma (separately randomised)
3. Aged greater than 18 years and less than 60 years, either sex

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

140

Participant exclusion criteria

1. Fluid overload pulmonary oedema
2. Known allergy to hydroxyethyl starch
3. Known pre-existing renal failure with oliguria including anuria, severe intracranial bleeding, severe hypernatremia or severe hyperchloremia on admission
4. Severe head injury from which they are unlikely to recover
5. Severe crush injury
6. Unrecordable blood pressure unresponsive to 2 l fluid loading
7. Clinically obvious cardiac tamponade
8. Neurogenic shock (high spinal)
9. Known acquired immune deficiency syndrome (AIDS) or AIDS related complex
10. Patients receiving dialysis treatment
11. Patients admitted greater than 6 hours following injury
12. Patients who have already received non-study colloids
13. Patients taking part in another clinical trial at the same time
14. Patients refusing consent

Recruitment start date

06/12/2007

Recruitment end date

31/12/2009

Locations

Countries of recruitment

South Africa

Trial participating centre

Department of Anaesthesia
Cape Town
7925
South Africa

Sponsor information

Organisation

University of Cape Town (South Africa)

Sponsor details

Department of Anaesthesia
Anzio Road
Observatory
Western Cape
7925
South Africa

Sponsor type

University/education

Website

http://www.uct.ac.za/

Funders

Funder type

University/education

Funder name

University of Cape Town (South Africa) - supported by an unrestricted educational grant from Fresenius Kabi Deutschland GmbH (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 results in http://bja.oxfordjournals.org/content/early/2011/08/19/bja.aer229

Publication citations

Additional files

Editorial Notes