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A trial of crystalloid versus colloid fluid solutions for the resuscitation of patients with severe injuries
ISRCTN ISRCTN42061860
DOI 10.1186/ISRCTN42061860
ClinicalTrials.gov identifier
EudraCT number
Public title A trial of crystalloid versus colloid fluid solutions for the resuscitation of patients with severe injuries
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)
Serial number at source N/A
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.
Lay summary Lay summary under review 2
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
Countries of recruitment South Africa
Disease/condition/study domain Severe blunt or penetrating trauma
Participants - 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
Participants - 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
Anticipated start date 06/12/2007
Anticipated end date 31/12/2009
Status of trial Completed
Patient information material Available in English/Afrikaans/Xhosa from mike.james@uct.ac.za
Target number of participants 140
Interventions 1. Intravenous fluid administration to haemodynamic and physiological endpoints as required, 0.9% saline
2. HES 130/0.4 in saline (Voluven®)
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.
Primary outcome measure(s) 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 measure(s) 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
Sources of funding University of Cape Town (South Africa) - supported by an unrestricted educational grant from Fresenius Kabi Deutschland GmbH (Germany)
Trial website
Publications 1. 2011 results in http://bja.oxfordjournals.org/content/early/2011/08/19/bja.aer229
Contact name Prof  Michael  James
  Address Department of Anaesthesia
University of Cape Town
Anzio Road
Observatory
Western Cape
  City/town Cape Town
  Zip/Postcode 7925
  Country South Africa
  Tel +27 (0)21 406 6143
  Fax +27 (0)21 447 5206
  Email mike.james@uct.ac.za
Sponsor University of Cape Town (South Africa)
  Address Department of Anaesthesia
Anzio Road
Observatory
  City/town Western Cape
  Zip/Postcode 7925
  Country South Africa
  Sponsor website: http://www.uct.ac.za/
Date applied 15/06/2009
Last edited 17/12/2012
Date ISRCTN assigned 24/07/2009
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