Prospective randomised controlled open-label explorative multi-centre

• Research type

  Research Study

• Full title

  Prospective randomised controlled open-label explorative multi-centre pilot trial of Volulyte®-supplemented versus Albumin-supplemented fluid resuscitation for major burns

• IRAS ID

  103520

• Contact name

  Naiem Moiemen

• Sponsor organisation

  Fresenius Kabi Deutschland GmbH

• Eudract number

  2011-005734-18

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Severe burn injuries are associated with loss of bodflud including loss of blood plasma resulting in the alteration of bodflud balance and internal circulatory issues. At the moment there is no consensus on the best type oflud for burns resuscitation other than it should contain replacement isotonic electrolytes (salts and sugars) which would have been lost from the body. Some UK burns centres use albumin at various different concentrations. Hydroxyethyl starch (HES) infusion solutions have been used for more than 30 years as plasma substitutes to replace the loss of blood volume. Volulyte© (6% HES 130/0.4 in an isotonic electrolyte solution) was developed to optimize the efficacy of the solution in burnflud resuscitation and reduction on blood clotting. Volulyte© is currently approved in many European member states for the treatment of low blood volume. In this study the aim is to compare twflud resuscitation regimes treatments for severe burn injuries: treatment Volulyte© - supplemented versus treatment Albumin-supplemented. These treatments help with thflud balance in the body system whilst recovery is taking place. Both products have been approved and used in this way worldwide for many years.The albumin-supplemented arm will be the controlled arm and is considered as the typical standard care based on Hartmann??s infusion (Lactate Ringer??s solution) as per modified Parkland regime (to calculate the volume oflud to administer over the first 24 hours post-burn) and 5% human serum albumin where required. The main objective of the study is to compare thflud balance at 24 hours after burn injury. The patients will be randomised (after assessment of eligibility and written consent form collection) within 8 hours of sustaining the burns injury to either the Volulyte©-supplemented arm or to the Albumin-supplemented arm. Both groups will receive the Ringer's Lactate solution up to 24 hours post injury and either Hartmann's and Volulyte© boluses in the Volulyte©-supplemented arm or just Hartmann's boluses for the first 8 hours in the Albumin-supplemented arm with the addition of Albumin boluses from 8 hours up to 24 hours. Beyond 24 hours post injury, thflud management will be according to standard of care for each site. Patients will be closely monitored for the first 7 days with follow up on Day 30 and Day 90 following the injury. This study will be conducted in up to 6 burns units in the UK and approximately 70 patients will be asked to participate in the study.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  12/SC/0393

• Date of REC Opinion

  23 Jul 2012

• REC opinion

  Favourable Opinion