Fluid Resuscitation in Patients Suffering From Burns Injury

Prospective Randomised Controlled Open-label Explorative Multi-centre Pilot Trial of Volulyte®-Supplemented Versus Albumin-supplemented Fluid Resuscitation for Major Burns

This clinical study compares two fluid resuscitation treatments in patients suffering from burns injury. The treatments are Volulyte® and Human Serum Albumin (HSA) which will be administered as infusion solutions. It will be evaluated whether Volulyte® is effective and safe, and provides any benefit.

Study Overview

• Status: Terminated
• Conditions: Burns
• Intervention / Treatment: Drug: Volulyte; Drug: Human Serum Albumin

Detailed Description

Severe burns injury presents a unique resuscitation problem due to simultaneous loss of electrolyte and protein-rich exudate from the burn wound itself and leakage of fluid and protein from the circulation into the interstitial compartment. In the post shock phase of burn resuscitation, patients frequently suffer oedema of unburned tissues and organs and a positive fluid balance of many litres. This pilot study will compare two burns fluid resuscitation regimes (supplementation with 6% HES 130/0.4 in an isotonic electrolyte solution, Volulyte 6%, versus supplementation with Human Serum Albumin, HSA 50g/L) on patient outcome with particular regard to fluid balance at 24 hours after burns injury (primary variable).

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 4

Contacts and Locations

Study Locations

• United Kingdom
  • Birmingham, United Kingdom, B15 2WB
    • University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Queen Elizabeth Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female patients ≥18 years of age
• 15%≥ Burn Total Body Surface Area Injury ≤60%
• Signed written informed consent from patient or legal representative

Exclusion Criteria:

• Patient age >80 years
• Delay of patient randomisation >8 hours post-burn
• Known pregnancy
• Known renal failure with oliguria or anuria not related to hypovolaemia (e.g. patients receiving dialysis treatment)
• High voltage electrical conduction injury
• Known severe liver disease
• Known fluid overload (hyperhydration), especially in cases of pulmonary oedema and congestive cardiac failure
• Intracranial bleeding (known active or suspicion of intracranial bleeding)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Volulyte; Volulyte 6%-supplemented arm: 6 % hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (solution for infusion)	Drug: Volulyte; 6 % hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution will be intravenously infused in order to achieve and maintain predefined hemodynamics goals and may be given up to a total daily dose of 50 mL/kg body weight/day.; Other Names: 6 % hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution
Active Comparator: Human Serum Albumin; 5% Albumin-supplemented arm: Human Serum Albumin (HSA 50g/L, solution for infusion)	Drug: Human Serum Albumin; 5% Human Serum Albumin will be intravenously infused in order to achieve and maintain predefined hemodynamics goals with no daily dose limit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cumulative fluid balance (input-output)	at 24 hours after burns injury

Secondary Outcome Measures

Outcome Measure	Time Frame
Cumulative fluid balance (input-output)	at 8 hours after burns injury, at 24 hours after randomisation, and until day 7 after burns injury
Oedema monitoring: patient's weight, circumference measurement of unburned limb	once daily until day 7 after burns injury
Urine output	hourly until 24 hours after burns injury, at 24 hours after randomization and, thereafter, once daily until day 7 after burns injury
Haemodynamics	hourly until 24 hours after burns injury, at 24 hours after randomization and, thereafter, 4 times daily until day 7 after burns injury
Bladder pressure	once daily until day 7 after burns injury
Use of vasoactive and inotropic drugs	until 24 hours after randomisation

Collaborators and Investigators

• Sponsor: Fresenius Kabi
• Investigators: Principal Investigator: Naiem Moiemen, PhD MD, Plastic and Burns Department, University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Queen Elizabeth Medical Centre

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: September 18, 2012
• First Submitted That Met QC Criteria: September 18, 2012
• First Posted (Estimate): September 21, 2012

Study Record Updates

• Last Update Posted (Estimate): June 26, 2014
• Last Update Submitted That Met QC Criteria: June 25, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: VOLU-011-C P4; 2011-005734-18 (EudraCT Number)