Fluid Resuscitation With HES 200/0.5 10% in Severe Burn I... | NCT01120730

Studies
Fluid Resuscitation With HES 200/0.5 10% in Severe Burn Injury

NCT01120730

Sponsor

University of Zurich

Status

Completed

Last Update Posted

May 11, 2010Estimated

Enrollment

28Actual

Phase

Phase 3

Conditions

Survival
Renal Failure

Interventions

fluid resuscitation
Fluid resuscitation

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

ID	Type	Description	Link
97/x	Other Identifier	kantonale Ethikkommision

Status Module

Record Verification Date

May 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1997

Primary Completion Date

Sep 1998Actual

Completion Date

Mar 2009Actual

First Submitted Date

Apr 28, 2010

First Submission Date that Met QC Criteria

May 7, 2010

First Posted Date

May 11, 2010Estimated

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

May 7, 2010

Last Update Posted Date

May 11, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

HES 200/0.5 10% is equal to ringers lactat solution.

Detailed Description

30 Patients were enrolled to the study, either to the hyperoncotic HES 200/0.5 (10%) group or to the crystalloids only group. After a treatment protocol of 72 hours we collected data about complications like pulmonary failure and abdominal compartment syndrome. Furthermore, we addressed the question of incidence of mortality and renal failure.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HES	Active Comparator	Fluid resuscitation with HES	Drug: fluid resuscitation
ringers lactat	Placebo Comparator	Standard treatment	Drug: Fluid resuscitation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
fluid resuscitation	Drug	fluid resuscitation with HES	HES
Fluid resuscitation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intensive care unit mortality	28 days	28 days

Secondary Outcomes

Measure	Description	Time Frame
fluid amount during the first 72 hours	Fluid resuscitation after burn	28 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All burn victims with burned surface area bigger than 20%

Exclusion Criteria:

Pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Markus Béchir, md	University of Zurich	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Zurich		Zurich		8091	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20584291	Derived	Bechir M, Puhan MA, Neff SB, Guggenheim M, Wedler V, Stover JF, Stocker R, Neff TA. Early fluid resuscitation with hyperoncotic hydroxyethyl starch 200/0.5 (10%) in severe burn injury. Crit Care. 2010;14(3):R123. doi: 10.1186/cc9086. Epub 2010 Jun 28.

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications