2024-514804-14-00招募中4 期
HALT : Influence of Human Albumin supplementation on kidney dysfunction after Liver Transplantation
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 8
- 主要终点
- Occurrence of Acute Kindey Injury during the first 7 days after liver transplantation (KDIGO criteria)
研究概览
简要总结
To verify whether albumin administration to achieve serum concentration above 30g/L (treated group) and its maintenance within plasmatic physiologic range (>30 g/L) for five days diminishes rate of AKI at Day 7 after liver transplantation as compared to restrained albumin administration (when serum concentration is at 20 g/L or below (control)).
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •IC1 - Male and female patients equal or above 18 yrs old.
- •IC2 - Recipients of primary liver allografts from a deceased donor (including after cardiac death) and as a single organ (liver only).
- •IC3 - Capability of understanding the purpose and risks of the study.
- •IC4 - Written informed consent
排除标准
- •NIC1 - Fulminant hepatitis
- •NIC2 - Kidney injury at baseline (eGFR < 50 ml/min in MDRD) including hepatorenal syndrome
- •NIC3 - Use of an induction agent Basiliximab at liver transplantation
- •NIC4 - Protected person (adults legally protected, under judicial protection, guardianship, or supervision), person deprived of their liberty
研究组 & 干预措施
HUMAN ALBUMIN SOLUTION
Test
干预措施: HUMAN ALBUMIN SOLUTION (Drug)
结局指标
主要结局
Occurrence of Acute Kindey Injury during the first 7 days after liver transplantation (KDIGO criteria)
Occurrence of Acute Kindey Injury during the first 7 days after liver transplantation (KDIGO criteria)
次要结局
- Postoperative calcineurin inhibitors-induced neurotoxicity at D28
- Occurrence of postoperative infections at D28
- Acute graft rejection (biopsy proved) at D28
- Occurrence of early graft dysfunction (Olthoff criteria)
- Duration of mechanical ventilation at D28
- Occurrence of reintubation at D28
- Duration of Intensive Care Unit length of stay up to D28
- Occurence of Intensive Care Unit readmission after discharge of Intensive Care Unit up to D28
- Mortality within the first 28 days following surgery
- Defined as a lymphocyte count less than 1.2× 103 cells/µL
- Using flow cytometry
- Using the Seahorse analyzer measuring mitochondrial respiration
- Occurrence and Severity of each Acute Kindey Injury during the first 7 days after liver transplantation (KDIGO Criteria)
- Hospital length of stay after liver transplantation defined by standardized checklist of discharged criteria
- Postoperative Tacrolimus-induced neurotoxicity at D28
- Discontinuation of anticalcineurin inhibitor at D28.
- Measured using expression of HLA-DR on peripheral monocytes, plasmatic levels of IL-10, MDSC, RNA seq analysis on peripheral blood mononuclear cell
- Plasmatic levels of IL-6
研究者
HOUSSEL-DEBRY pauline
Scientific
Centre Hospitalier Universitaire De Rennes
研究点 (8)
Loading locations...
相似试验
招募中
2 期
Safety and efficacy of a human albumin solution with restored structural profile in patients with decompensated cirrhosisdecompensated cirrhosis2024-515484-54-00Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico88
撤回
3 期
An European multinational study of a personalized approach of human albumin administration in patients with cirrhosis of the liver and complications2022-501006-34-00Odense University Hospital, European Foundation For The Study Of Chronic Liver Failure180
招募中
3 期
ALBU-CHIP - Efficacy of human 20% albumin solution + Ringer Lactate versus Ringer Lactate for fluid replacement strategy during cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy : a randomized clinical trial2024-510943-76-00Assistance Publique Hopitaux De Paris140
进行中（未招募）
不适用
Measurement of Mass Change in Serum Albumin Compared to Serum Lactic Acid as Predictive Tool for Sepsis Prognosis in Non Surgical ICU PatientsNCT07289906Ain Shams University40
招募中
不适用
Albumin-bound Paclitaxel-based Second-line Treatment Regimens for Locally Advanced or Metastatic G/GEJ AdenocarcinomaGastric CancerNCT07389876Fudan University250