NCT05683444

Octreotide Improves Human Lymphatic Fluid Transport a Translational Trial

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 20 Years – 35 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Lymphatic Diseases
• Chylothorax

Interventions

Type	Name	Description
DRUG	Octreotide infusion	Octreotide infusion for 2,5 hours. 300 ng/kg/min bolus was given for the first 15 minutes and then a continuous infusion of 100 ng/kg/min for the remaining 135 minutes.
DRUG	Saline infusion	Saline Infusion

Timeline

• Start date: 2020-07-01
• Primary completion: 2021-03-26
• Completion: 2021-03-26
• First posted: 2023-01-13
• Last updated: 2023-03-30

Locations

1 site across 1 country: Denmark