patients with major burns
Conditions
Interventions
Trade Name: Volulyte 6% Solution for Infusion
Pharmaceutical Form: Solution for infusion
Trade Name: Albunorm 5%, 50g/l, solution for infusion
Pharmace
Sponsors
Fresenius Kabi Deutschland GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients =18 years of age 2. 15%= Burn TBSA Injury =60% 3. Signed written informed consent from patient or legal representative Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1. Patient age >80 years 2. Delay of patient randomisation >8 hours post-burn 3. Known pregnancy (for female patients with childbearing potential a pregnancy test must be obtained as soon as possible after enrolment and in case of pregnancy, a patient must be excluded from this clinical study) 4. Known renal failure with oliguria or anuria not related to hypovolaemia (e.g. patients receiving dialysis treatment) 5. Known or suspected hypersensitivity to hydroxyethyl starch (such as rash), including its ingredients (including corn) and related drugs 6. Known or suspected allergy to human albumin preparations, including its ingredients and related drugs 7. High voltage electrical conduction injury 8. Known severe liver disease 9. Known fluid overload (hyperhydration), especially in cases of pulmonary oedema and congestive cardiac failure (patients presenting with a fluid overload on admission due to initial fluid therapy may be included at the discretion of the investigator) 10. Intracranial bleeding (known active or suspicion of intracranial bleeding) 11. Participation in another interventional clinical study within 30 days prior to enrolment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This explorative 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 HSA 50g/L) on outcome with particular regard to fluid balance at 24 hours after burns injury (primary variable). ;Secondary Objective: Key secondary objectives are to compare the development of oedema, urine output, haemodynamics, bladder pressure, the use of vasoactive and inotropic drugs, and fluid balance at different time points throughout the study. Furthermore, the study will obtain patient outcome data as well as safety data.;Primary end point(s): Cumulative fluid balance;Timepoint(s) of evaluation of this end point: at 24 hours after burns injury | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key secondary endpoints: - Cumulative fluid balance (input-output) - Oedema monitoring: patient’s weight, circumference measurement of unburned limb - Urine output - Haemodynamics: HR, BP, MAP, CVP - Bladder pressure - Vasoactive and inotropic drugs ; Timepoint(s) of evaluation of this end point: Cumulative fluid balance (input-output): at 8 hours after burns injury, at 24 hours after randomisation, and until day 7 (144±12 hours after burns injury); Oedema monitoring: once daily until day 7 after burns injury; Urine output: hourly until 24 hours after burns injury, at 24 hours after randomisation and, therafter, once daily until day 7 after burns injury; Haemodynamics: hourly until 24 hours after burns injury, at 24 hours after randomisation and, therafter, 4 times daily until day 7 after burns injury; Bladder pressure: once daily until day 7 after burns injury; Vasoactive and inotropic drugs: until 24 hours after randomisation; | — |
Countries
United Kingdom
Contacts
Public ContactBC Pharmaceuticals Clinical Affairs
Fresenius Kabi Deutschland GmbH
Outcome results
None listed