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Fluid Resuscitation in Patients Suffering From Burns Injury

Information source: Fresenius Kabi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Burns

Intervention: Volulyte (Drug); Human Serum Albumin (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Fresenius Kabi

Official(s) and/or principal investigator(s):
Naiem Moiemen, PhD MD, Principal Investigator, Affiliation: Plastic and Burns Department, University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Queen Elizabeth Medical Centre

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.

Clinical Details

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

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

Primary outcome: Cumulative fluid balance (input-output)

Secondary outcome:

Cumulative fluid balance (input-output)

Oedema monitoring: patient's weight, circumference measurement of unburned limb

Urine output

Haemodynamics

Bladder pressure

Use of vasoactive and inotropic drugs

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).

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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)

Locations and Contacts

University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Queen Elizabeth Medical Centre, Birmingham B15 2WB, United Kingdom
Additional Information

Starting date: December 2012
Last updated: June 25, 2014

Page last updated: August 23, 2015

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