E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
patients with major burns |
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E.1.1.1 | Medical condition in easily understood language |
patients suffering from burns injury |
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E.1.1.2 | Therapeutic area | Diseases [C] - Injuries, poisonings, and occupational diseases [C21] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
This explorative 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 HSA 50g/L) on outcome with particular regard to fluid balance at 24 hours after burns injury (primary variable). |
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E.2.2 | Secondary objectives of the trial |
Key secondary objectives are to compare the development of oedema, urine output, haemodynamics, bladder pressure, the use of vasoactive and inotropic drugs, and fluid balance at different time points throughout the study. Furthermore, the study will obtain patient outcome data as well as safety data. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female patients ≥18 years of age
2. 15%≥ Burn TBSA Injury ≤60%
3. Signed written informed consent from patient or legal representative
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E.4 | Principal exclusion criteria |
1. Patient age >80 years
2. Delay of patient randomisation >8 hours post-burn
3. Known pregnancy (for female patients with childbearing potential a pregnancy test must be obtained as soon as possible after enrolment and in case of pregnancy, a patient must be excluded from this clinical study)
4. Known renal failure with oliguria or anuria not related to hypovolaemia (e.g. patients receiving dialysis treatment)
5. Known or suspected hypersensitivity to hydroxyethyl starch (such as rash), including its ingredients (including corn) and related drugs
6. Known or suspected allergy to human albumin preparations, including its ingredients and related drugs
7. High voltage electrical conduction injury
8. Known severe liver disease
9. Known fluid overload (hyperhydration), especially in cases of pulmonary oedema and congestive cardiac failure (patients presenting with a fluid overload on admission due to initial fluid therapy may be included at the discretion of the investigator)
10. Intracranial bleeding (known active or suspicion of intracranial bleeding)
11. Participation in another interventional clinical study within 30 days prior to enrolment
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
at 24 hours after burns injury |
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E.5.2 | Secondary end point(s) |
Key secondary endpoints:
- Cumulative fluid balance (input-output)
- Oedema monitoring: patient’s weight, circumference measurement of unburned limb
- Urine output
- Haemodynamics: HR, BP, MAP, CVP
- Bladder pressure
- Vasoactive and inotropic drugs
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Cumulative fluid balance (input-output):
at 8 hours after burns injury, at 24 hours after randomisation, and
until day 7 (144±12 hours after burns injury);
Oedema monitoring:
once daily until day 7 after burns injury;
Urine output:
hourly until 24 hours after burns injury, at 24 hours after randomisation and, therafter, once daily until day 7 after burns injury;
Haemodynamics:
hourly until 24 hours after burns injury, at 24 hours after randomisation and, therafter, 4 times daily until day 7 after burns injury;
Bladder pressure:
once daily until day 7 after burns injury;
Vasoactive and inotropic drugs:
until 24 hours after randomisation;
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |