Fluid Resuscitation in Patients Suffering From Burns Injury

Overview

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.

Full Title of Study: “Prospective Randomised Controlled Open-label Explorative Multi-centre Pilot Trial of Volulyte®-Supplemented Versus Albumin-supplemented Fluid Resuscitation for Major Burns”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2013

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).

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

  • Experimental: Volulyte
    • Volulyte 6%-supplemented arm: 6 % hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (solution for infusion)
  • Active Comparator: Human Serum Albumin
    • 5% Albumin-supplemented arm: Human Serum Albumin (HSA 50g/L, solution for infusion)

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Cumulative fluid balance (input-output)
    • Time Frame: 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
    • Time Frame: once daily until day 7 after burns injury
  • Urine output
    • Time Frame: hourly until 24 hours after burns injury, at 24 hours after randomization and, thereafter, once daily until day 7 after burns injury
  • Haemodynamics
    • Time Frame: 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
    • Time Frame: once daily until day 7 after burns injury
  • Use of vasoactive and inotropic drugs
    • Time Frame: until 24 hours after randomisation

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fresenius Kabi
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Naiem Moiemen, PhD MD, Principal Investigator, Plastic and Burns Department, University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Queen Elizabeth Medical Centre

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