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Octreotide Improves Human Lymphatic Fluid Transport a Translational Trial

Octreotide Improves Human Lymphatic Fluid Transport a Translational Trial

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05683444
Enrollment
16
Registered
2023-01-13
Start date
2020-07-01
Completion date
2021-03-26
Last updated
2023-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chylothorax, Lymphatic Diseases

Brief 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.

Interventions

DRUGOctreotide 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.

DRUGSaline infusion

Saline Infusion

Sponsors

University of Aarhus
CollaboratorOTHER
Bispebjerg Hospital
CollaboratorOTHER
Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

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.

Intervention model description

Double-blinded cross over study

Eligibility

Sex/Gender
ALL
Age
20 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

\* Healthy

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Lymph rateDuring infusionPropulsions /minute
Lymph PressureDuring infusionmmHg assessed by near-infra fluorescence imaging
Capillary filtration rateDuring infusionassessed by plethysmography
Capillary filtration coefficiencyDuring infusionassessed by plethysmography
Isovolumetric pressureDuring infusionassessed by plethysmography

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026