Fluid Resuscitation in Patients Suffering From Burns Injury

Phase 4TerminatedNCT01689506

Fresenius Kabi11 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Burns

Interventions

VolulyteDRUG

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 AlbuminDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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)

Locations (1)

University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Queen Elizabeth Medical Centre

Birmingham, United Kingdom

Outcomes

Primary Outcomes

Cumulative fluid balance (input-output)

Time frame: at 24 hours after burns injury

Secondary Outcomes

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

Data from ClinicalTrials.gov

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