BurnsPhase 4NCT01689506
Fluid Resuscitation in Patients Suffering From Burns Injury
A Phase 4 study testing Volulyte and Human Serum Albumin in people with Burns, run by Fresenius Kabi at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Burns
- What is being tested?
- Volulyte and Human Serum Albumin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2012to Sep 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Queen Elizabeth Medical Centre
Birmingham, B15 2WB
About this study
Official title: Prospective Randomised Controlled Open-label Explorative Multi-centre Pilot Trial of Volulyte®-Supplemented Versus Albumin-supplemented Fluid Resuscitation for Major Burns
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.
Read the 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
- Being tested
- Volulyte, Human Serum Albumin
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VolulyteDrug
Also called 6 % hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution
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 AlbuminDrug
5% Human Serum Albumin will be intravenously infused in order to achieve and maintain predefined hemodynamics goals with no daily dose limit.
| Study group | Role | What they receive |
|---|---|---|
| Volulyte | Experimental | Volulyte 6%-supplemented arm: 6 % hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (solution for infusion) Receives: Drug: Volulyte |
| Human Serum Albumin | Active comparator | 5% Albumin-supplemented arm: Human Serum Albumin (HSA 50g/L, solution for infusion) Receives: Drug: Human Serum Albumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative fluid balance (input-output)
Measured: at 24 hours after burns injury
Secondary outcomes (6)
Cumulative fluid balance (input-output)
Measured: 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
Measured: once daily until day 7 after burns injury
Urine output
Measured: hourly until 24 hours after burns injury, at 24 hours after randomization and, thereafter, once daily until day 7 after burns injury
Haemodynamics
Measured: 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
Measured: once daily until day 7 after burns injury
Use of vasoactive and inotropic drugs
Measured: until 24 hours after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2012 (estimated)
- Study startDec 2012
- Primary completionSep 2013
- Study completionSep 2013
Why it stopped: Study stopped due to low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Kabi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Naiem Moiemen, PhD MD, Principal investigator, Plastic and Burns Department, University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Queen Elizabeth Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01689506
- Sponsor's protocol ID
- VOLU-011-C P4
- Other IDs
- 2011-005734-18
- Status last verified
- Jun 2014
- First submitted
- 18 Sep 2012
- Last updated
- 26 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomised Controlled Open-label Explorative Multi-centre Pilot Trial of Volulyte®-Supplemented Versus Albumin-supplemented Fluid Resuscitation for Major Burns
- ClinicalTrials.gov ID
- NCT01689506
- Acronym / sponsor ID
- VOLU-011-C P4
- Conditions
- Burns
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study stopped due to low recruitment
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Fresenius KabiIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 21 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Volulyte | Experimental | Drug: VolulyteVolulyte 6%-supplemented arm: 6 % hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (solution for infusion) |
| Human Serum Albumin | Active comparator | Drug: Human Serum Albumin5% Albumin-supplemented arm: Human Serum Albumin (HSA 50g/L, solution for infusion) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VolulyteAlso: 6 % hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution6 % 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. | Drug | Volulyte |
| Human Serum Albumin5% Human Serum Albumin will be intravenously infused in order to achieve and maintain predefined hemodynamics goals with no daily dose limit. | Drug | Human Serum Albumin |
Primary outcome
Cumulative fluid balance (input-output)
Time frame: at 24 hours after burns injury
6 secondary outcomes
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
Oedema monitoring: patient's weight, circumference measurement of unburned limb
Time frame: once daily until day 7 after burns injury
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
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
Bladder pressure
Time frame: once daily until day 7 after burns injury
Use of vasoactive and inotropic drugs
Time frame: until 24 hours after randomisation
Results and safety
The study was stopped early (reason given: Study stopped due to low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naiem Moiemen, PhD MD principal investigator
Plastic and Burns Department, University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Queen Elizabeth Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Volulyte and Human Serum Albumin in people with Burns, run by Fresenius Kabi at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study stopped due to low recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative fluid balance (input-output) (time frame: at 24 hours after burns injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2014.