Fluid Resuscitation in Patients Suffering From Burns Injury

Study Overview
=================
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).

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

Conditions
-----------------
Burns

Intervention / Treatment
-----------------
* Drug: Volulyte
* Drug: Human Serum Albumin


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Volulyte<br>Volulyte 6%-supplemented arm: 6 % hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (solution for infusion) | Drug: Volulyte<br>* 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.<br>* Other names: 6 % hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution;|
| Active Comparator: Human Serum Albumin<br>5% Albumin-supplemented arm: Human Serum Albumin (HSA 50g/L, solution for infusion) | Drug: Human Serum Albumin<br>* 5% Human Serum Albumin will be intravenously infused in order to achieve and maintain predefined hemodynamics goals with no daily dose limit.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |