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Fluid Resuscitation in Patients Suffering From Burns Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01689506
Recruitment Status : Terminated (Study stopped due to low recruitment)
First Posted : September 21, 2012
Last Update Posted : June 26, 2014
Sponsor:
Information provided by (Responsible Party):
Fresenius Kabi

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.

Condition or disease Intervention/treatment Phase
Burns Drug: Volulyte Drug: Human Serum Albumin Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomised Controlled Open-label Explorative Multi-centre Pilot Trial of Volulyte®-Supplemented Versus Albumin-supplemented Fluid Resuscitation for Major Burns
Study Start Date : December 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Arm Intervention/treatment
Experimental: Volulyte
Volulyte 6%-supplemented arm: 6 % hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (solution for infusion)
Drug: 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.
Other Name: 6 % hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution

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




Primary Outcome Measures :
  1. Cumulative fluid balance (input-output) [ Time Frame: at 24 hours after burns injury ]

Secondary Outcome Measures :
  1. 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 ]
  2. Oedema monitoring: patient's weight, circumference measurement of unburned limb [ Time Frame: once daily until day 7 after burns injury ]
  3. 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 ]
  4. 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 ]
  5. Bladder pressure [ Time Frame: once daily until day 7 after burns injury ]
  6. Use of vasoactive and inotropic drugs [ Time Frame: until 24 hours after randomisation ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01689506


Locations
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United Kingdom
University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Queen Elizabeth Medical Centre
Birmingham, United Kingdom, B15 2WB
Sponsors and Collaborators
Fresenius Kabi
Investigators
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Principal Investigator: Naiem Moiemen, PhD MD Plastic and Burns Department, University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Queen Elizabeth Medical Centre
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Responsible Party: Fresenius Kabi
ClinicalTrials.gov Identifier: NCT01689506    
Other Study ID Numbers: VOLU-011-C P4
2011-005734-18 ( EudraCT Number )
First Posted: September 21, 2012    Key Record Dates
Last Update Posted: June 26, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Burns
Wounds and Injuries