EUCTR2011-005734-18-GB进行中（未招募）1 期
Prospective randomised controlled open-label explorative multi-centre pilot trial of Volulyte®-supplemented versus Albumin-supplemented fluid resuscitation for major burns
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 9
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •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
研究者
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