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.

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).

Volulyte 6%-supplemented arm: 6 % hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (solution for infusion)

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.

5% Human Serum Albumin will be intravenously infused in order to achieve and maintain predefined hemodynamics goals with no daily dose limit.

hourly until 24 hours after burns injury, at 24 hours after randomization and, thereafter, once daily until day 7 after burns injury

hourly until 24 hours after burns injury, at 24 hours after randomization and, thereafter, 4 times daily until day 7 after burns injury

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)

Plastic and Burns Department, University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Queen Elizabeth Medical Centre

University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Queen Elizabeth Medical Centre