Octreotide Improves Human Lymphatic Fluid Transport a Translational Trial
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Lymph Pressure
研究概览
简要总结
This study aims to investigate whether octreotide, a medication used off-label to treat chylothorax, has a direct effect on human lymphatic drainage. To study the effects of octreotide, the researchers conducted a pre-clinical experiment using human lymphatic vessels mounted in a myograph chamber and a clinical experiment in which a double-blinded, randomized, cross-over trial was conducted in 16 healthy adults. The results of the study will be used to determine the role of octreotide in the treatment of chylothorax and other lymphatic disorders.
详细描述
This study aimed to investigate whether octreotide, a medication used off-label to treat chylothorax, has a direct effect on human lymphatic drainage. Chylothorax is a condition in which there is an accumulation of lymphatic fluid in the chest cavity, and the mechanism through which octreotide helps to resolve this condition is not well understood. It has been speculated that the drug may reduce lymph production, but this has not been directly demonstrated. To study the effects of octreotide on human lymphatic vessels, the investigators conducted two experiments: a pre-clinical experiment using human lymphatic vessels mounted in a myograph chamber, and a clinical experiment in which a double-blinded, randomized, cross-over trial was conducted in 16 healthy adults, assessed by using plethysmography and near-infrared fluorescence imaging. The results of the study will be used to determine the role of octreotide in the treatment of chylothorax and to clarify the mechanism through which it acts. It is important to continue researching and developing effective treatments for chylothorax, as it can be a difficult condition to manage and may cause serious complications if left untreated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Neither the participant nor investigator nor outcomes assessor was aware of whether saline or octreotide was infused on the day of investigation and data analysis.
入排标准
- 年龄范围
- 20 Years 至 35 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •No daily medication (except birth control), or allergies towards contrast agents.
研究组 & 干预措施
Healthy participant 1
干预措施: Octreotide infusion (Drug)
Healthy participant 1
干预措施: Saline infusion (Drug)
Healthy participant 2
干预措施: Octreotide infusion (Drug)
Healthy participant 2
干预措施: Saline infusion (Drug)
结局指标
主要结局
Lymph Pressure
时间窗: During infusion
mmHg assessed by near-infra fluorescence imaging
Isovolumetric pressure
时间窗: During infusion
assessed by plethysmography
Capillary filtration rate
时间窗: During infusion
assessed by plethysmography
Capillary filtration coefficiency
时间窗: During infusion
assessed by plethysmography
Lymph rate
时间窗: During infusion
Propulsions /minute
次要结局
未报告次要终点
研究者
Thomas Holm-Weber
Medical Doctor, Principal Investigator
Rigshospitalet, Denmark
