CIST: Colloids in Severe Trauma

Sponsor

University of the Philippines (Other)

Overall Status

Completed

CT.gov ID

NCT00890383

Collaborator

Fresenius Kabi (Industry)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

4.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Abdominal Hypertension Abdominal Compartment Syndrome Severe Trauma	Drug: tetrastarch (Voluven)	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Colloids in Severe Trauma: A Multi-Center Pilot Study of "Crystalloid Only" or "Crystalloid + Colloid" Volume Resuscitation in Trauma Patients (CIST)

Study Start Date :

May 1, 2009

Actual Primary Completion Date :

Nov 1, 2009

Actual Study Completion Date :

Nov 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Crystalloid only patients will receive crystalloid fluids only for volume therapy of severe trauma
Active Comparator: Colloid + Crystalloid arm Goal directed volume therapy for severe trauma resuscitation	Drug: tetrastarch (Voluven) Goals directed volume therapy for severe trauma resuscitation Other Names: Voluven

Arm

Intervention/Treatment

No Intervention: Crystalloid only

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

Active Comparator: Colloid + Crystalloid arm

Goal directed volume therapy for severe trauma resuscitation

Drug: tetrastarch (Voluven)

Goals directed volume therapy for severe trauma resuscitation

Other Names:

Voluven

Outcome Measures

Primary Outcome Measures

Intraabdominal hypertension [30 days]

Secondary Outcome Measures

abdominal compartment syndrome [30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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