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Colloids in Severe Trauma (CIST)

This study has been completed.
Sponsor:
Collaborator:
Fresenius Kabi
Information provided by:
University of the Philippines
ClinicalTrials.gov Identifier:
NCT00890383
First received: April 28, 2009
Last updated: November 23, 2009
Last verified: November 2009
History of Changes
  Purpose

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 Intervention Phase
Abdominal Hypertension
Abdominal Compartment Syndrome
Severe Trauma
 Drug: tetrastarch (Voluven)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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)

Resource links provided by NLM:

Drug Information available for: Hetastarch
U.S. FDA Resources

Further study details as provided by University of the Philippines:

Primary Outcome Measures:
  • Intraabdominal hypertension [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • abdominal compartment syndrome [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: May 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Voluven

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00890383

Locations
Philippines
Jose Reyes Memorial Medical Center
Manila, Metro Manila, Philippines
East Avenue Medical Center
Quezon City, NCR, Philippines
Sponsors and Collaborators
University of the Philippines
Fresenius Kabi
Investigators
Principal Investigator: Rafael J Consunji, MD MPH University of the Philippines
  More Information

No publications provided

Responsible Party: Dr. Rafael Consunji, Clinical Associate Professor of Surgery and Chief of Surgical ICU, Dept. of Surgery, College of Medicine, University of the Philippines, Manila
ClinicalTrials.gov Identifier: NCT00890383     History of Changes
Other Study ID Numbers: GCS Sur 2007-030
Study First Received: April 28, 2009
Last Updated: November 23, 2009
Health Authority: Philippines: Bureau of Food and Drugs

Keywords provided by University of the Philippines:
trauma resuscitation
abdominal hypertension
abdominal compartment syndrome

Additional relevant MeSH terms:
Compartment Syndromes
Hypertension
Wounds and Injuries
Muscular Diseases
Musculoskeletal Diseases
Vascular Diseases
Cardiovascular Diseases
 Hetastarch
Plasma Substitutes
Blood Substitutes
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013