EUCTR2021-001806-32-SE招募中1 期
Influence of Argipressin on blood loss and inflammatory response during hepatic resection; a double blinded, randomized, placebo-controlled trial
Sahlgrenska University Hospital0 个研究点目标入组 248 人开始时间: 2021年11月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 248
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
- •1.Participant planned for hepatic resection (open or laparoscopic, regardless of indication for surgery).
- •2.Age =18 years.
- •3.ASA class I-III.
- •4.Signed informed consent form
- •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 124
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 124
排除标准
- •1.Participant does not understand the given information, and/ or cannot give written informed consent.
- •2.Simultaneous operation of tumor with other localization, or surgery for superficial single hepatic tumor less than 2 cm, expected to be of short duration and with minimal blood loss.
- •3.Terminal kidney failure (estimated preoperative GFR< 15 ml/min)
- •4.Pregnancy or lactation.
- •5.Known allergy to Empressin®.
- •6.Patient included in other interventional study, interacting with the endpoints in the present study, or previous randomization in this study.
- •7.Hyponatremia (S-Na < 130 mmol/L)
- •8.Patient considered ineligible for other surgical or medical reason.
- •9.Present infection
- •Patients with systemic inflammatory disease, inflammatory bowel disease or preoperative corticosteroid treatment will not be eligible for the subgroups (extended testing) where cytokines and interleukins are investigated
研究者
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