Octreotide Improves Human Lymphatic Fluid Transport a Translational Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Octreotide Improves Human Lymphatic Fluid Transport a Translational Trial

Conditions
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Lymphatic Diseases, Chylothorax

Intervention / Treatment
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* Drug: Octreotide infusion
* Drug: Saline infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: * Healthy Exclusion Criteria: No daily medication (except birth control), or allergies towards contrast agents.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Double-blinded cross over study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Healthy participant 1<br> | Drug: Octreotide infusion<br>* 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.<br>Drug: Saline infusion<br>* Saline Infusion<br>|
| Other: Healthy participant 2<br> | Drug: Octreotide infusion<br>* 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.<br>Drug: Saline infusion<br>* Saline Infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lymph rate | Propulsions /minute | During infusion | 
| Lymph Pressure | mmHg assessed by near-infra fluorescence imaging | During infusion | 
| Capillary filtration rate | assessed by plethysmography | During infusion | 
| Capillary filtration coefficiency | assessed by plethysmography | During infusion | 
| Isovolumetric pressure | assessed by plethysmography | During infusion |