Prospective Randomised Controlled Open-label Explorative Multi-centre Pilot Trial of Volulyte®-Supplemented Versus Albumin-supplemented Fluid Resuscitation for Major Burns
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Cumulative fluid balance (input-output)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Volulyte
Volulyte 6%-supplemented arm: 6 % hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (solution for infusion)
干预措施: Volulyte (Drug)
Human Serum Albumin
5% Albumin-supplemented arm: Human Serum Albumin (HSA 50g/L, solution for infusion)
干预措施: Human Serum Albumin (Drug)
结局指标
主要结局
Cumulative fluid balance (input-output)
时间窗: at 24 hours after burns injury
次要结局
- 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)
- Bladder pressure(once daily until day 7 after burns injury)
- Use of vasoactive and inotropic drugs(until 24 hours after randomisation)
- Haemodynamics(hourly until 24 hours after burns injury, at 24 hours after randomization and, thereafter, 4 times daily until day 7 after burns injury)