ISRCTN26993825进行中（未招募）未知
Palliative long-term abdominal drains versus repeated drainage in untreatable ascites due to advanced cirrhosis: A randomised controlled trial (REDUCe 2 study)
niversity of Sussex0 个研究点目标入组 310 人开始时间: 2022年8月15日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 310
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current participant inclusion criteria as of 01/11/2023:
- •Patient inclusion criteria:
- •1. Aged 18 years old and over
- •2. Refractory ascites due to cirrhosis (with the need for one or more LVP per month), defined as per International Ascites Club criteria (5-6):
- •3. Diuretic-resistant ascites: ascites that cannot be mobilized or the early recurrence of which cannot be prevented because of a lack of response to sodium restriction and diuretic treatment (spironolactone 400 mg and furosemide 160 mg) and or Diuretic-intractable ascites: ascites that cannot be mobilized or the early recurrence of which cannot be prevented because of the development of diuretic-induced complications that preclude the use of an effective diuretic dosage
- •4. Registered with a GP in the community Trusts served by the participating centres.
- •Previous participant inclusion criteria:
- •Patient inclusion criteria:
- •1. Aged 18 years old and over
- •2. Refractory ascites (with the need for one or more LVP per month), defined as per International Ascites Club criteria (5-6):
- •3. Diuretic-resistant ascites: ascites that cannot be mobilized or the early recurrence of which cannot be prevented because of a lack of response to sodium restriction and diuretic treatment (spironolactone 400 mg and furosemide 160 mg) and or Diuretic-intractable ascites: ascites that cannot be mobilized or the early recurrence of which cannot be prevented because of the development of diuretic-induced complications that preclude the use of an effective diuretic dosage
- •4. Registered with a GP in the community Trusts served by the participating centres.
排除标准
- •Patient exclusion criteria:
- •1. Loculated and or chylous ascites
- •2. Evidence of active infection that in the investigator’s opinion would preclude insertion of LTAD (for example, bacterial peritonitis) – such patients would need to receive appropriate treatment and could then be reconsidered
- •3. A candidate for liver transplantation and or TIPS
- •4. Psychosocial issues which in the opinion of the medical team will preclude study participation
- •5. Pregnancy - all women of childbearing age must have a negative pregnancy test
研究者
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