Severe blunt or penetrating trauma Injury, Occupational Diseases, Poisoning Severe trauma
Conditions
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. Durat
follow-up for 30 days from enrolment or death.
Sponsors
University of Cape Town (South Africa)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
South Africa
Outcome results
None listed