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临床试验/NCT05683444
NCT05683444已完成早期 1 期

Octreotide Improves Human Lymphatic Fluid Transport a Translational Trial

Rigshospitalet, Denmark1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2020年7月1日最近更新:
适应症
干预措施
相关药物

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

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

Other

干预措施: Octreotide infusion (Drug)

Healthy participant 1

Other

干预措施: Saline infusion (Drug)

Healthy participant 2

Other

干预措施: Octreotide infusion (Drug)

Healthy participant 2

Other

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Thomas Holm-Weber

Medical Doctor, Principal Investigator

Rigshospitalet, Denmark

研究点 (1)

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