Early Fluid Resuscitation With Balanced HES 130/0.4 [6%]... | NCT01012648

Studies
Early Fluid Resuscitation With Balanced HES 130/0.4 [6%] in Severe Burn Injury

NCT01012648

Sponsor

University of Zurich

Status

Unknown status

Last Update Posted

Mar 16, 2011Estimated

Enrollment

48Estimated

Phase

Phase 4

Conditions

Burns

Interventions

Fluid resuscitation
HES 130/0.4 (6%), Voluven balanced vs. Lactated Ringer's solution

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Jan 2013Estimated

Completion Date

Jan 2013Estimated

First Submitted Date

Oct 29, 2009

First Submission Date that Met QC Criteria

Nov 12, 2009

First Posted Date

Nov 13, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 15, 2011

Last Update Posted Date

Mar 16, 2011Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fluid resuscitation	Drug	Volume resuscitation
HES 130/0.4 (6%), Voluven balanced vs. Lactated Ringer's solution	Drug	Volume Resuscitation

Measure	Description	Time Frame
Reduced amount of fluids given		3 days

Eligibility Module

Eligibility Criteria

Inclusion criteria:

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

Exclusion criteria:

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")

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
01 Studienregister MasterAdmins	Contact	+41 (0)44 255 11 11

Overall Officials

Name	Affiliation	Role
Markus Béchir, M.D:	UniversitaetsSpital Zuerich	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Surgical ICU	Recruiting	Zurich		8091	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24365167	Derived	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.

ID	Term
D013213	Starch
D004040	Dietary Carbohydrates
D002241	Carbohydrates
D005936	Glucans