Fluid Resuscitation in Patients Suffering From Burns Injury

Burns Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01689506
• Other study ID #: VOLU-011-C P4
• Secondary ID: 2011-005734-18
• Status: Terminated
• Phase: Phase 4
• First received: September 18, 2012
• Last updated: June 25, 2014
• Start date: December 2012
• Est. completion date: September 2013

Study information

• Verified date: June 2014
• Source: Fresenius Kabi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burns

Intervention

Drug:
• Volulyte
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.
• Human Serum Albumin
5% Human Serum Albumin will be intravenously infused in order to achieve and maintain predefined hemodynamics goals with no daily dose limit.

Locations

Country	Name	City	State
United Kingdom	University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Queen Elizabeth Medical Centre	Birmingham

Sponsors (1)

Lead Sponsor	Collaborator
Fresenius Kabi

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative fluid balance (input-output)		at 24 hours after burns injury	No
Secondary	Cumulative fluid balance (input-output)		at 8 hours after burns injury, at 24 hours after randomisation, and until day 7 after burns injury	No
Secondary	Oedema monitoring: patient's weight, circumference measurement of unburned limb		once daily until day 7 after burns injury	No
Secondary	Urine output		hourly until 24 hours after burns injury, at 24 hours after randomization and, thereafter, once daily until day 7 after burns injury	No
Secondary	Haemodynamics		hourly until 24 hours after burns injury, at 24 hours after randomization and, thereafter, 4 times daily until day 7 after burns injury	No
Secondary	Bladder pressure		once daily until day 7 after burns injury	No
Secondary	Use of vasoactive and inotropic drugs		until 24 hours after randomisation	No