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临床试验/EUCTR2021-001806-32-SE
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

发起方
Sahlgrenska University Hospital

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