Colloids in Severe Trauma

NCT00890383 | Completed Phase 4 DMC

• 1 other identifier: GCS Sur 2007-030
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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 result, these controversies have been the subject of numerous clinical trials, evidence-based guidelines and systematic reviews. With the publication of the landmark SAFE Study the equipoise between the 2 treatments (which were representative solutions for colloid and crystalloids respectively), 4% albumin and saline, was established. This has however been brought into further doubt by the paucity of data on the use of hydroxyethylstarches (HES), which are less costly and have less side effects than albumin, in trauma. More recent findings by Gruen and colleagues have shown that as much as 5% of all trauma deaths are the result of fluid overload based on the North American fluid management model for trauma (pure crystalloid fluid management). A meta-analysis done by Kern and Shoemaker found that supranormal fluid resuscitation with crystalloids is beneficial when given before the onset of organ failure in critically ill surgical patients. Balogh and colleagues found out that when supranormal fuid resuscitation with crystalloids was applied to victims of severe trauma, this resulted in a statistically significant increase in the incidence of mortality, multiple organ failure, intra-abdominal hypertension (IAH) and abdominal compartment syndrome (ACS). More recently, Kirkpatrick and colleagues reviewed and defined a 'secondary' ACS as a direct result of fluid resuscitation. They concluded that "excess resuscitation with crystalloid fluids might be harming patients and contributing to an increased occurrence of ACS." This study will serve as a pilot to test the hypothesis that there will be significant differences in clinical outcomes for patients with severe trauma treated with colloid (HES) plus crystalloid and crystalloid only fluid management regimens, most notably the incidence of IAH and ACS. It is hoped that the hybrid colloid (HES) plus crystalloid fluid management regimen will provide a means to avoid the untoward fluid overload and/or other complications of pure crystalloid fluid management and the costs/complications of albumin administration.

Conditions

Abdominal Hypertension; Abdominal Compartment Syndrome; Severe Trauma

Keywords

trauma resuscitation; abdominal hypertension; abdominal compartment syndrome

Outcome Measures

Primary Outcomes (1)

• Intraabdominal hypertension

  30 days

Secondary Outcomes (1)

• abdominal compartment syndrome

  30 days

Study Arms (2)

Crystalloid only

NO INTERVENTION

patients will receive crystalloid fluids only for volume therapy of severe trauma

Colloid + Crystalloid arm

ACTIVE COMPARATOR

Goal directed volume therapy for severe trauma resuscitation

Drug: tetrastarch (Voluven)

Interventions

tetrastarch (Voluven) DRUG

Goals directed volume therapy for severe trauma resuscitation

Also known as: Voluven

Colloid + Crystalloid arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-65 years
• Body weight: more than 40 kg
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of the Philippines: lead
• Fresenius Kabi: collaborator

Study Sites (2)

Jose Reyes Memorial Medical Center

Manila, National Capital Region, Philippines

Location

East Avenue Medical Center

Quezon City, NCR, Philippines

Location

MeSH Terms

Conditions

Intra-Abdominal Hypertension; Wounds and Injuries

Interventions

HES 130-0.4

Condition Hierarchy (Ancestors)

Compartment Syndromes; Muscular Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Rafael J Consunji, MD MPH

  University of the Philippines

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 28, 2009
• First Posted: April 29, 2009
• Study Start: May 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: November 25, 2009

Record last verified: 2009-11

Locations

PH (2)