Burns
Conditions
Brief summary
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.
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
DRUGVolulyte
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.
Sponsors
Fresenius Kabi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative fluid balance (input-output) | at 24 hours after burns injury |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Cumulative fluid balance (input-output) | at 8 hours after burns injury, at 24 hours after randomisation, and 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 |
| Haemodynamics | hourly until 24 hours after burns injury, at 24 hours after randomization and, thereafter, 4 times daily until day 7 after burns injury |
Countries
United Kingdom
Outcome results
None listed