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Octreotide Improves Human Lymphatic Fluid Transport a Translational Trial

Early Phase 1CompletedNCT05683444
Rigshospitalet, Denmark16 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

16

Conditions

Lymphatic DiseasesChylothorax

Interventions

Octreotide infusionDRUG

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.

Saline infusionDRUG

Saline Infusion

Eligibility

Sex: ALLMin age: 20 YearsMax age: 35 YearsHealthy volunteers:
Medical Language ↔ Plain English
Inclusion Criteria: \* Healthy Exclusion Criteria: * No daily medication (except birth control), or allergies towards contrast agents.

Locations (1)

Rigshospitalet

København Ø, Denmark

Outcomes

Primary Outcomes

Lymph rate

Propulsions /minute

Time frame: During infusion

Lymph Pressure

mmHg assessed by near-infra fluorescence imaging

Time frame: During infusion

Capillary filtration rate

assessed by plethysmography

Time frame: During infusion

Capillary filtration coefficiency

assessed by plethysmography

Time frame: During infusion

Isovolumetric pressure

assessed by plethysmography

Time frame: During infusion

Data from ClinicalTrials.gov

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