Fluid Resuscitation in Patients Suffering From Burns Injury

Fresenius Kabi

Status and phase: Terminated; Phase 4

Conditions: Burns

Treatments: Drug: Volulyte; Drug: Human Serum Albumin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01689506

2011-005734-18 (EudraCT Number)

VOLU-011-C P4

Details and patient eligibility

About

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.

Full 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).

Enrollment: 11 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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11 participants in 2 patient groups

Volulyte

Experimental group

Description:

Volulyte 6%-supplemented arm: 6 % hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (solution for infusion)

Treatment:

Drug: Volulyte

Human Serum Albumin

Active Comparator group

Description:

5% Albumin-supplemented arm: Human Serum Albumin (HSA 50g/L, solution for infusion)

Treatment:

Drug: Human Serum Albumin