跳至主要内容
临床试验/NCT06321874
NCT06321874已完成不适用

Exploring Postoperative Effects of Hyperoxic Intermittent Stimuli on Reticulocytes Levels in Abdominal Surgery: A Randomized Single-blind Study

Jules Bordet Institute2 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2011年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
49
试验地点
2
主要终点
Percentage change in reticulocyte count

研究概览

简要总结

The aims of the research is to determine whether a Hyperoxic intermittent stimuli protocol can increase reticulocyte counts, signififying a rise in EPO production, in patients undergoing abdominal surgery

详细描述

For anemia treatment in cancer patients, human recombinant erythropoietin is often used. However, its application is constrained due to high costs, side effects, and limited availability in some regions. This research and clinical exploration aim to identify an tool alternative to transfusion.

Randomization was conducted post-surgery in a 1:1 ratio across groups: Normobaric Oxygen Paradox (NOP) group, and a control (CTR) group. The NOP group received 60% oxygen for two hours on days 1, 3, and 5 post-surgery using a venti-mask. The CTR group did not receive oxygen therapy during the post-operatory period starting from day 1. All patients could receive oxygen during the surgery and the first 24 hours post-surgery (day 0) as needed. The belonging to one group or the other was blinded to the laboratory staff.

Pre-surgery, all patients were administered an oral benzodiazepine. General anesthesia was employed, potentially combined with epidural techniques and standard anesthesia monitors were used. The choice of anesthesia technique was at the discretion of the anesthetist. During surgery, patients received 40-50% FiO2 ventilation and were extubated at the surgery's end. Post-surgery, patients were admitted to the ICU for at least 24 hours, receiving oxygen if saturation dropped below 98%. The oxygen protocol commenced 24 hours after ICU admission (day 1). The transfusion threshold was set at 8 g/dl with clinical signs.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Care Provider)

盲法说明

The belonging to one group or the other was blinded to the laboratory staff.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients undergoing abdominal oncological surgery

排除标准

  • GFR<60 ml/minute and/ or creatinine serum level > 2mg/dl
  • Transfusion of red blood cells per or postoperatively
  • Bleeding requiring repeated transfusions during or after surgery
  • Severe respiratory syndrome necessitating continuous oxygen
  • Intolerance to oxygen mask

结局指标

主要结局

Percentage change in reticulocyte count

时间窗: 6 days

Percentage change in reticulocyte count from baseline to day six within each group

次要结局

  • haemoglobin levels mesure(6 days)
  • haematocrit levels mesure(6 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Effects of Oxygen After Abdominal Oncological Surgery | 临床试验