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Colloids in Severe Trauma (CIST)

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ClinicalTrials.gov Identifier: NCT00890383
Recruitment Status : Completed
First Posted : April 29, 2009
Last Update Posted : November 25, 2009
Sponsor:
Collaborator:
Fresenius Kabi
Information provided by:
University of the Philippines

Tracking Information
First Submitted Date  ICMJE April 28, 2009
First Posted Date  ICMJE April 29, 2009
Last Update Posted Date November 25, 2009
Study Start Date  ICMJE May 2009
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2009)
Intraabdominal hypertension [ Time Frame: 30 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2009)
abdominal compartment syndrome [ Time Frame: 30 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Colloids in Severe Trauma
Official Title  ICMJE Colloids in Severe Trauma: A Multi-Center Pilot Study of "Crystalloid Only" or "Crystalloid + Colloid" Volume Resuscitation in Trauma Patients (CIST)
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Abdominal Hypertension
  • Abdominal Compartment Syndrome
  • Severe Trauma
Intervention  ICMJE Drug: tetrastarch (Voluven)
Goals directed volume therapy for severe trauma resuscitation
Other Name: Voluven
Study Arms  ICMJE
  • 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
    Intervention: Drug: tetrastarch (Voluven)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: April 28, 2009)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2009
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Philippines
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00890383
Other Study ID Numbers  ICMJE GCS Sur 2007-030
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not 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
Study Sponsor  ICMJE University of the Philippines
Collaborators  ICMJE Fresenius Kabi
Investigators  ICMJE
Principal Investigator: Rafael J Consunji, MD MPH University of the Philippines
PRS Account University of the Philippines
Verification Date November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP