Abdominal HypertensionPhase 4CISTNCT00890383
Colloids in Severe Trauma
A Phase 4 study testing tetrastarch (Voluven) in people with Abdominal Hypertension and Abdominal Compartment Syndrome, run by University of the Philippines at 2 sites in Philippines.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Abdominal Hypertension, Abdominal Compartment Syndrome, Severe Trauma
- What is being tested?
- tetrastarch (Voluven)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesPhilippines
- Study dates
- May 2009to Nov 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Philippines2 sites
Jose Reyes Memorial Medical Center
Manila, National Capital Region
East Avenue Medical Center
Quezon City, NCR
About this study
Official title: Colloids in Severe Trauma: A Multi-Center Pilot Study of "Crystalloid Only" or "Crystalloid + Colloid" Volume Resuscitation in Trauma Patients (CIST)
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.
Read more
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.
- Being tested
- tetrastarch (Voluven)
- Keywords
- trauma resuscitation, abdominal hypertension, abdominal compartment syndrome
- Medical subject headings
- Intra-Abdominal Hypertension, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tetrastarch (Voluven)Drug
Also called Voluven
Goals directed volume therapy for severe trauma resuscitation
| Study group | Role | What they receive |
|---|---|---|
| Crystalloid only | No intervention | patients will receive crystalloid fluids only for volume therapy of severe trauma |
| Colloid + Crystalloid arm | Active comparator | Goal directed volume therapy for severe trauma resuscitation Receives: Drug: tetrastarch (Voluven) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraabdominal hypertension
Measured: 30 days
Secondary outcomes (1)
abdominal compartment syndrome
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the Philippines
- Sponsor type
- University, hospital or other
- Collaborators
- Fresenius Kabi
- Investigators
- Rafael J Consunji, MD MPH, Principal investigator, University of the Philippines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00890383
- Sponsor's protocol ID
- GCS Sur 2007-030
- Acronym
- CIST
- Status last verified
- Nov 2009
- First submitted
- 28 Apr 2009
- Last updated
- 25 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colloids in Severe Trauma: A Multi-Center Pilot Study of "Crystalloid Only" or "Crystalloid + Colloid" Volume Resuscitation in Trauma Patients (CIST)
- ClinicalTrials.gov ID
- NCT00890383
- Acronym / sponsor ID
- CIST / GCS Sur 2007-030
- Keywords
- trauma resuscitation, abdominal hypertension, abdominal compartment syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of the PhilippinesUniversity, hospital or other
- Collaborators
- Fresenius Kabi
- Study start
- May 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 29 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crystalloid only | No intervention | –patients will receive crystalloid fluids only for volume therapy of severe trauma |
| Colloid + Crystalloid arm | Active comparator | Drug: tetrastarch (Voluven)Goal directed volume therapy for severe trauma resuscitation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tetrastarch (Voluven)Also: VoluvenGoals directed volume therapy for severe trauma resuscitation | Drug | Colloid + Crystalloid arm |
Primary outcome
Intraabdominal hypertension
Time frame: 30 days
1 secondary outcome
abdominal compartment syndrome
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2009.
Related trials for Abdominal Hypertension
Not yet recruitingObservational study
Intra-Abdominal Pressure, Respiratory Mechanics, and Ventilator Liberation After Emergency Major Laparotomy
Intra-Abdominal Hypertension, Respiratory Mechanics
Not yet recruitingObservational study
Cumulative Intra-Abdominal Pressure Burden and Acute Kidney Injury After Emergency Abdominal Surgery
Acute Kidney Injury, Intra-Abdominal Hypertension
Not yet recruiting
Post-exercise Blood Pressure With Inorganic Nitrate
Obese Individuals, Central Adiposity
RecruitingObservational study
Intra-Abdominal Pressure Changes During Continuous Renal Replacement Therapy in Critically Ill Patients
Intra-Abdominal Hypertension, Critical Illness
Recruiting
Culturally Adapted Dietary Clinical Trial in PR
Diabetes Mellitus, Type 2, Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rafael J Consunji, MD MPH principal investigator
University of the Philippines
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tetrastarch (Voluven) in people with Abdominal Hypertension and Abdominal Compartment Syndrome, run by University of the Philippines at 2 sites in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraabdominal hypertension (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2009.