Fluid Resuscitation in Patients Suffering From Burns Injury

NCT ID: NCT01689506

Last Updated: 2014-06-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2013-09-30

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).

Conditions

Burns

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Volulyte

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

Group Type: EXPERIMENTAL

Volulyte

Intervention Type: DRUG

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

Group Type: ACTIVE_COMPARATOR

Human Serum Albumin

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

6 % hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fresenius Kabi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Naiem Moiemen, PhD MD

Role: PRINCIPAL_INVESTIGATOR

Plastic and Burns Department, University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Queen Elizabeth Medical Centre

Locations

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

Birmingham, , United Kingdom

Countries

United Kingdom

Other Identifiers

2011-005734-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

VOLU-011-C P4

Identifier Type: -

Identifier Source: org_study_id