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Colloids in Severe Trauma (CIST)

Primary Purpose

Abdominal Hypertension, Abdominal Compartment Syndrome, Severe Trauma

Status
Completed
Phase
Phase 4
Locations
Philippines
Study Type
Interventional
Intervention
tetrastarch (Voluven)
Sponsored by
University of the Philippines
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Hypertension focused on measuring trauma resuscitation, abdominal hypertension, abdominal compartment syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Jose Reyes Memorial Medical Center
  • East Avenue Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Crystalloid only

Colloid + Crystalloid arm

Arm Description

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

Goal directed volume therapy for severe trauma resuscitation

Outcomes

Primary Outcome Measures

Intraabdominal hypertension

Secondary Outcome Measures

abdominal compartment syndrome

Full Information

First Posted
April 28, 2009
Last Updated
November 23, 2009
Sponsor
University of the Philippines
Collaborators
Fresenius Kabi
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1. Study Identification

Unique Protocol Identification Number
NCT00890383
Brief Title
Colloids in Severe Trauma
Acronym
CIST
Official Title
Colloids in Severe Trauma: A Multi-Center Pilot Study of "Crystalloid Only" or "Crystalloid + Colloid" Volume Resuscitation in Trauma Patients (CIST)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of the Philippines
Collaborators
Fresenius Kabi

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Hypertension, Abdominal Compartment Syndrome, Severe Trauma
Keywords
trauma resuscitation, abdominal hypertension, abdominal compartment syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Crystalloid only
Arm Type
No Intervention
Arm Description
patients will receive crystalloid fluids only for volume therapy of severe trauma
Arm Title
Colloid + Crystalloid arm
Arm Type
Active Comparator
Arm Description
Goal directed volume therapy for severe trauma resuscitation
Intervention Type
Drug
Intervention Name(s)
tetrastarch (Voluven)
Other Intervention Name(s)
Voluven
Intervention Description
Goals directed volume therapy for severe trauma resuscitation
Primary Outcome Measure Information:
Title
Intraabdominal hypertension
Time Frame
30 days
Secondary Outcome Measure Information:
Title
abdominal compartment syndrome
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rafael J Consunji, MD MPH
Organizational Affiliation
University of the Philippines
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jose Reyes Memorial Medical Center
City
Manila
State/Province
Metro Manila
Country
Philippines
Facility Name
East Avenue Medical Center
City
Quezon City
State/Province
NCR
Country
Philippines

12. IPD Sharing Statement

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Colloids in Severe Trauma

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