A trial of crystalloid versus colloid fluid solutions for the resuscitation of patients with severe injuries

Not Applicable

Completed

Conditions: Severe blunt or penetrating trauma
Injury, Occupational Diseases, Poisoning
Severe trauma

Registration Number: ISRCTN42061860

Lead Sponsor: niversity of Cape Town (South Africa)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 140

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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