A Phase 4 interventional study of Volulyte and Human Serum Albumin in Burns, sponsored by Fresenius Kabi. Terminated at 1 site in United Kingdom. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-06-26.
Sponsored by Fresenius Kabi · Phase 4, Interventional, and Treatment
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).
719 studies on the registry are indexed under Burns; 145 are open to participants now.
This study's enrollment of 11 is below the median of 40 across 524 interventional studies indexed under Burns.
Browse Burns studies →Fresenius Kabi is the lead sponsor of 51 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Volulyte 6%-supplemented arm: 6 % hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (solution for infusion)
Drug: Volulyte
5% Albumin-supplemented arm: Human Serum Albumin (HSA 50g/L, solution for infusion)
Drug: Human Serum Albumin
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.
Also known as: 6 % hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution
5% Human Serum Albumin will be intravenously infused in order to achieve and maintain predefined hemodynamics goals with no daily dose limit.
Cumulative fluid balance (input-output)
Time frame: at 24 hours after burns injury
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
This study is terminated, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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Fresenius Kabi