Fluid Resuscitation in Patients Suffering From Burns Injury

• Status: Terminated
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fresenius Kabi
• Treatments: Hydroxyethyl Starch Derivatives; Pharmaceutical Solutions

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)