Early Fluid Resuscitation With Balanced HES 130/0.4 [6%] in Severe Burn Injury
1 other identifier
interventional
48
1 country
1
Brief Summary
RCT colloids versus cristalloids only in severe burn victims.
- Trial with medicinal product
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Nov 2009
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2009
CompletedStudy Start
First participant enrolled
November 1, 2009
CompletedFirst Posted
Study publicly available on registry
November 13, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedMarch 16, 2011
March 1, 2011
3.2 years
October 29, 2009
March 15, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Reduced amount of fluids given
3 days
Interventions
Volume resuscitation
Volume Resuscitation
Eligibility Criteria
You may qualify if:
- Deep burn injury more than 15% of total body surface area (2nd and 3rd degree burns)
- Informed consent (via deferred consent, if necessary, according to Swiss HMG § 55 and 56).
- Patients or relatives can understand the study information and the provided information in German language
You may not qualify if:
- Patients expected to succumb within the next 24 to 36 hours, i.e. whole body burn trauma, palliative care situation
- Pregnancy
- No informed consent
- Known allergic reaction to HES
- Patients or patient's relatives, who do not understand the German language and therefore the study information, can not be provided in a legally correct manner.
- Patients with contraindications for balanced 6% HES 130/0.4, i.e. heart failure, pulmonary edema, intracerebral bleeding, acute renal failure, severe hypernatraemia and other severe electrolyte imbalances, severe von-Willebrand Syndrome and acute liver failure (see "Arzneimittelkompendium der Schweiz® - Documed")
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Surgical ICU
Zurich, 8091, Switzerland
Related Publications (1)
Bechir M, Puhan MA, Fasshauer M, Schuepbach RA, Stocker R, Neff TA. Early fluid resuscitation with hydroxyethyl starch 130/0.4 (6%) in severe burn injury: a randomized, controlled, double-blind clinical trial. Crit Care. 2013 Dec 23;17(6):R299. doi: 10.1186/cc13168.
PMID: 24365167DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Markus Béchir, M.D:
UniversitaetsSpital Zuerich
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 29, 2009
First Posted
November 13, 2009
Study Start
November 1, 2009
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
March 16, 2011
Record last verified: 2011-03