NCT01689506

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 21, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

June 26, 2014

Status Verified

June 1, 2014

Enrollment Period

9 months

First QC Date

September 18, 2012

Last Update Submit

June 25, 2014

Conditions

Burns

Outcome Measures

Primary Outcomes (1)

  • Cumulative fluid balance (input-output)

    at 24 hours after burns injury

Secondary Outcomes (6)

  • Cumulative fluid balance (input-output)

    at 8 hours after burns injury, at 24 hours after randomisation, and until day 7 after burns injury

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

    once daily until day 7 after burns injury

  • Urine output

    hourly until 24 hours after burns injury, at 24 hours after randomization and, thereafter, once daily until day 7 after burns injury

  • Haemodynamics

    hourly until 24 hours after burns injury, at 24 hours after randomization and, thereafter, 4 times daily until day 7 after burns injury

  • Bladder pressure

    once daily until day 7 after burns injury

  • +1 more secondary outcomes

Study Arms (2)

Volulyte

EXPERIMENTAL

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

Drug: Volulyte

Human Serum Albumin

ACTIVE COMPARATOR

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

Drug: Human Serum Albumin

Interventions

VolulyteDRUG

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.

Also known as: 6 % hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution
Volulyte
Human Serum AlbuminDRUG

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

Human Serum Albumin

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female patients ≥18 years of age
  • %≥ Burn Total Body Surface Area Injury ≤60%
  • Signed written informed consent from patient or legal representative

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Birmingham, B15 2WB, United Kingdom

Location

MeSH Terms

Conditions

Burns

Interventions

Hydroxyethyl Starch DerivativesSerum Albumin, Human

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

StarchDietary CarbohydratesCarbohydratesGlucansPolysaccharidesSerum AlbuminAlbuminsProteinsAmino Acids, Peptides, and ProteinsBlood Proteins

Study Officials

  • Naiem Moiemen, PhD MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2012

First Posted

September 21, 2012

Study Start

December 1, 2012

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

June 26, 2014

Record last verified: 2014-06

Locations

GB(1)