Colloids in Severe Trauma

NCT ID: NCT00890383

Last Updated: 2009-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2009-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Crystalloid only

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Colloid + Crystalloid arm

Goal directed volume therapy for severe trauma resuscitation

Group Type: ACTIVE_COMPARATOR

tetrastarch (Voluven)

Intervention Type: DRUG

Goals directed volume therapy for severe trauma resuscitation

Interventions

tetrastarch (Voluven)

Goals directed volume therapy for severe trauma resuscitation

Intervention Type: DRUG

Other Intervention Names

Voluven

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fresenius Kabi

INDUSTRY

Sponsor Role: collaborator

University of the Philippines

OTHER

Sponsor Role: lead

Responsible Party

Dept. of Surgery, College of Medicine, University of the Philippines, Manila

Principal Investigators

Rafael J Consunji, MD MPH

Role: PRINCIPAL_INVESTIGATOR

University of the Philippines

Locations

Jose Reyes Memorial Medical Center

Manila, National Capital Region, Philippines

East Avenue Medical Center

Quezon City, NCR, Philippines

Countries

Philippines

Other Identifiers

GCS Sur 2007-030

Identifier Type: -

Identifier Source: org_study_id