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

Burns Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01012648
• Other study ID #: BURN
• Status: Recruiting
• Phase: Phase 4
• First received: October 29, 2009
• Last updated: March 15, 2011
• Start date: November 2009
• Est. completion date: January 2013

Study information

• Verified date: March 2011
• Source: University of Zurich
• Contact: 01 Studienregister MasterAdmins
• Phone: +41 (0)44 255 11 11
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

RCT colloids versus cristalloids only in severe burn victims.

• Trial with medicinal product

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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")

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burns

Intervention

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

Locations

Country	Name	City	State
Switzerland	Surgical ICU	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduced amount of fluids given		3 days	No