Status:
COMPLETED
Colloids in Severe Trauma
Lead Sponsor:
University of the Philippines
Collaborating Sponsors:
Fresenius Kabi
Conditions:
Abdominal Hypertension
Abdominal Compartment Syndrome
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Background: Fluid resuscitation is a cornerstone of the initial management of the critically injured trauma patient yet there are numerous controversies surrounding this very common practice. As a re...
Eligibility Criteria
Inclusion
- Age: 18-65 years
- Body weight: more than 40 kg
- Trauma patients with onset of trauma ≤ 48h prior to assessment for inclusion in study, clinically judged to be in hemorrhagic shock by the attending surgeon and with 2 or more of the following characteristics:
- Penetrating or blunt etiology with hemodynamic instability at ER or intra-operatively
- Severely injured with Injury Severity Score (ISS) \> 15
- Hypotension defined as either ≥ 10mmHg change in SBP or MAP ≤ 65 mmHg or needing vasopressors (dopamine ≥ 5 mcg/kg/min or norepinephrine at any dose) at the time of admission/referral
- Hypoperfusion defined as base deficit ≥ 4 mmol/L
Exclusion
- Known severe congestive heart failure (EF ≤ 35%)
- Known chronic renal, liver or pancreatic disease
- Known severe respiratory diseases e.g., TB, COPD, asthma
- Known coagulopathy or bleeding tendency
- Known allergy to Hydroxyethyl starch
- Participation in a clinical drug trial within the last 2 months
- Known Pregnancy or lactation
- Severe traumatic brain injury GCS \< 9
- Advanced cancer (stage IV or metastatic disease)
- Patients receiving immunosuppressive drugs
- Do-not-resuscitate status
- Advanced directives restricting implementation of the protocol
- Skeletal deformity, scarring, infection, gross contamination or previous surgery at the CVP insertion site
- Severe hypoxemia if the CVP is to be inserted in the subclavian area
- Known active gastrointestinal hemorrhage
- Concomitant drug poisoning
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2009
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00890383
Start Date
May 1 2009
End Date
November 1 2009
Last Update
November 25 2009
Active Locations (2)
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1
Jose Reyes Memorial Medical Center
Manila, National Capital Region, Philippines
2
East Avenue Medical Center
Quezon City, NCR, Philippines