BurnsPhase 4NCT01012648
Early Fluid Resuscitation With Balanced HES 130/0.4 [6%] in Severe Burn Injury
A Phase 4 study testing Fluid resuscitation and HES 130/0.4 (6%), Voluven balanced vs. Lactated Ringer's solution in people with Burns, run by University of Zurich at 1 site in Switzerland.
Trial summary
RCT colloids versus cristalloids only in severe burn victims. Trial with medicinal product Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Burns
- What is being tested?
- Fluid resuscitation and HES 130/0.4 (6%), Voluven balanced vs. Lactated Ringer's solution
- How many people
- 48 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2009to Jan 2013
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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")
Trial locations and contacts
1 site in 1 country.
01 Studienregister MasterAdmins contact
Switzerland1 site, 1 recruiting
- Recruiting
Surgical ICU
Zurich, 8091
Markus Béchir, M.D.
Markus Béchir, M.D.
About this study
RCT colloids versus cristalloids only in severe burn victims.
- Trial with medicinal product
- Conditions
- Burns
- Being tested
- Fluid resuscitation, HES 130/0.4 (6%), Voluven balanced vs. Lactated Ringer's solution
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid resuscitationDrug
Volume resuscitation
HES 130/0.4 (6%), Voluven balanced vs. Lactated Ringer's solutionDrug
Volume Resuscitation
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduced amount of fluids given
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionJan 2013 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Investigators
- Markus Béchir, M.D:, Principal investigator, UniversitaetsSpital Zuerich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01012648
- Sponsor's protocol ID
- BURN
- Status last verified
- Mar 2011
- First submitted
- 29 Oct 2009
- Last updated
- 16 Mar 2011
- Results posted
- No
Publications
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.
PubMed 24365167
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Fluid Resuscitation With Balanced HES 130/0.4 [6%] in Severe Burn Injury
- ClinicalTrials.gov ID
- NCT01012648
- Acronym / sponsor ID
- BURN
- Conditions
- Burns
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 13 Nov 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.
RCT colloids versus cristalloids only in severe burn victims.
- Trial with medicinal product
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Fluid resuscitationVolume resuscitation | Drug | – |
| HES 130/0.4 (6%), Voluven balanced vs. Lactated Ringer's solutionVolume Resuscitation | Drug | – |
Primary outcome
Reduced amount of fluids given
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2011.
- Derived from this study: PubMed 24365167Bechir 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.
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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.
01 Studienregister MasterAdmins contact
Markus Béchir, M.D: principal investigator
UniversitaetsSpital Zuerich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluid resuscitation and HES 130/0.4 (6%), Voluven balanced vs. Lactated Ringer's solution in people with Burns, run by University of Zurich at 1 site in Switzerland.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 16 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact 01 Studienregister MasterAdmins (+41 (0)44 255 11 11), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduced amount of fluids given (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01012648, which also lists 1 linked publication.
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 16 Mar 2011.