NCT00842803Unknown不适用
Post-Operative Use of Salt Poor Albumin Solution in Resuscitation of Orthotopic Liver Transplant Recipients Status 1-2. A Prospective Randomized Controlled Trial.
McGill University Health Centre/Research Institute of the McGill University Health Centre1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2010年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Post Transplant Liver Function Test (PTLFT)
研究概览
简要总结
The purpose of the study is to examine if outcome after liver transplantation is improved by using albumin infusion post-transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Canadian Transplant status 1 or 2
- •Patients at the Royal Victoria Hospital, Montreal, Canada
排除标准
- •Emergency liver transplant (canadian transplant status 3 or 4)
- •patients who have received more than 300cc of albumin within 48 hours prior to transplant
- •patients who underwent previous solid organ transplant
- •multi-organs transplant recipients
- •patients who had previous adverse reaction to human albumin solution
- •patients who have religious restriction to receiving human blood products.
- •patients or surrogate unable to give consent to the study
研究组 & 干预措施
Albumin group
Experimental
Patients in this arm will receive albumin infusions 3 times a day for the first 7 days post-operative
干预措施: Albumin infusion (25% albumin) (Drug)
结局指标
主要结局
Post Transplant Liver Function Test (PTLFT)
时间窗: Post-operative Day1 through 7 and Day 15,30, 45
次要结局
- Functional 6 minutes walking test(Post-operative)
- Calculated creatinine clearance(Post-operative day 1, 7, 15, 30, 45)
- Length of hospital stay(post-operative)
- ICU length of stay(post-operative)
- duration of mechanical ventilation(post-operative)
- duration of renal replacement therapy(postoperative)
- ICU readmission rate(post-operative)
- Post-operative infection rate(Post-operative)
- Functional hand grip Jamar Dynamometer hand grip test(Post-op day 7, 15, 30)
- reintubation rate(post-operative)
- Need to re-operation unrelated to technical complication(post-operative)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
SUbstition of PERioperative Albumin Deficiency DisordersHypoalbuminemiaNCT03167645Technical University of Munich600
已完成
4 期
Efficacy of Albumin for Acute Encephalopathy in Patients With CirrhosisHepatic EncephalopathyNCT00886925Hospital Universitari Vall d'Hebron Research Institute56
Unknown
不适用
Effect of Synbiotic on Postoperative Complications After Liver TransplantationLiver DiseaseNCT02938871Hospital de Clinicas de Porto Alegre76
Unknown
不适用
Omega 3 Lipid Emulsions and Liver TransplantationIschemia Re-perfusion InjuryNCT01957943Mansoura University114
终止
4 期
The INFECIR-2 Albumin Prevention StudyPneumoniaAdvanced Chronic Liver DiseaseUrinary InfectionOther Bacterial DiseasesCholangitisNCT02034279EASL - CLIF Consortium136