Fluid Resuscitation in Patients Suffering From Burns Injury

Phase 4

Terminated

• Conditions: Burns
• Interventions: Drug: Volulyte; Drug: Human Serum Albumin

• Registration Number: NCT01689506
• Lead Sponsor: Fresenius Kabi

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).

Study Timeline

• Study First Submitted: 2012-09-18
• Study First Submitted QC: 2012-09-18
• Study First Posted: 2012-09-21
• Study Start: 2012-12
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-25
• Last Update Posted: 2014-06-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Volulyte	Volulyte	Volulyte 6%-supplemented arm: 6 % hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (solution for infusion)
Human Serum Albumin	Human Serum Albumin	5% Albumin-supplemented arm: Human Serum Albumin (HSA 50g/L, solution for infusion)

Primary Outcome Measures

Name	Time	Method
Cumulative fluid balance (input-output)	at 24 hours after burns injury

Secondary Outcome Measures

Name	Time	Method
Cumulative fluid balance (input-output)	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	once daily until day 7 after burns injury
Urine output	hourly until 24 hours after burns injury, at 24 hours after randomization and, thereafter, once daily until day 7 after burns injury
Bladder pressure	once daily until day 7 after burns injury
Use of vasoactive and inotropic drugs	until 24 hours after randomisation
Haemodynamics	hourly until 24 hours after burns injury, at 24 hours after randomization and, thereafter, 4 times daily until day 7 after burns injury

Trial Locations

Locations (1)

University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Queen Elizabeth Medical Centre; 🇬🇧 Birmingham, United Kingdom