Clinical trial NCT01689506: Fluid Resuscitation in Patients Suffering From Burns Injury
Official title: Prospective Randomised Controlled Open-label Explorative Multi-centre Pilot Trial of Volulyte®-Supplemented Versus Albumin-supplemented Fluid Resuscitation for Major Burns
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Burns
Lead sponsor: Fresenius Kabi
Sponsor class: INDUSTRY
First posted: 2012-09-21
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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)

Primary outcomes:
measure: Cumulative fluid balance (input-output)
timeFrame: at 24 hours after burns injury
Secondary outcomes:
measure: Cumulative fluid balance (input-output)
timeFrame: at 8 hours after burns injury, at 24 hours after randomisation, and until day 7 after burns injury
measure: Oedema monitoring: patient's weight, circumference measurement of unburned limb
timeFrame: once daily until day 7 after burns injury
measure: Urine output
timeFrame: hourly until 24 hours after burns injury, at 24 hours after randomization and, thereafter, once daily until day 7 after burns injury
measure: Haemodynamics
timeFrame: hourly until 24 hours after burns injury, at 24 hours after randomization and, thereafter, 4 times daily until day 7 after burns injury
measure: Bladder pressure
timeFrame: once daily until day 7 after burns injury
measure: Use of vasoactive and inotropic drugs
timeFrame: until 24 hours after randomisation
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Queen Elizabeth Medical Centre
Study officials:
affiliation: Plastic and Burns Department, University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Queen Elizabeth Medical Centre
name: Naiem Moiemen, PhD MD
role: PRINCIPAL_INVESTIGATOR
References: