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Completed

NCT Number: NCT05683444

Octreotide Improves Human Lymphatic Fluid Transport a Translational Trial

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.

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Key information

Conditions

Lymphatic Diseases Chylothorax Hemic and Lymphatic Diseases Pleural Diseases Respiratory Tract Diseases

Age range

20 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Rigshospitalet

København Ø, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy

Exclusion criteria

  • No daily medication (except birth control), or allergies towards contrast agents.

Treatment and study plan

Octreotide infusion

Drug

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 infusion

Drug

Saline Infusion

Primary outcomes

  1. Lymph rate

    Time frame: During infusion

    Propulsions /minute

  2. Lymph Pressure

    Time frame: During infusion

    mmHg assessed by near-infra fluorescence imaging

  3. Capillary filtration rate

    Time frame: During infusion

    assessed by plethysmography

  4. Capillary filtration coefficiency

    Time frame: During infusion

    assessed by plethysmography

  5. Isovolumetric pressure

    Time frame: During infusion

    assessed by plethysmography

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Bispebjerg Hospital
  • University of Aarhus

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 13, 2023
Registry last updated
Mar 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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