Colloids in Severe Trauma

Abdominal Compartment Syndrome Clinical Trial

— CIST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00890383
• Other study ID #: GCS Sur 2007-030
• Status: Completed
• Phase: Phase 4
• First received: April 28, 2009
• Last updated: November 23, 2009
• Start date: May 2009
• Est. completion date: November 2009

Study information

• Verified date: November 2009
• Source: University of the Philippines
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines: Bureau of Food and Drugs
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Compartment Syndrome
• Abdominal Hypertension
• Compartment Syndromes
• Intra-Abdominal Hypertension
• Severe Trauma
• Wounds and Injuries

Intervention

Drug:
• tetrastarch (Voluven)
Goals directed volume therapy for severe trauma resuscitation

Locations

Country	Name	City	State
Philippines	Jose Reyes Memorial Medical Center	Manila	Metro Manila
Philippines	East Avenue Medical Center	Quezon City	NCR

Sponsors (2)

Lead Sponsor	Collaborator
University of the Philippines	Fresenius Kabi

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraabdominal hypertension		30 days	Yes
Secondary	abdominal compartment syndrome		30 days	Yes