Octreotide Improves Human Lymphatic Fluid Transport a Translational Trial

Sponsor

Rigshospitalet, Denmark (Other)

Overall Status

Completed

CT.gov ID

NCT05683444

Collaborator

University of Aarhus (Other), Bispebjerg Hospital (Other)

Enrollment

Location

Arms

8.8

Actual Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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 wass 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.

Condition or Disease	Intervention/Treatment	Phase
Lymphatic Diseases Chylothorax	Drug: Octreotide Injection Drug: Saline infusion	N/A

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, we 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 Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Double blinded cross over studyDouble blinded cross over study

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Octreotide Improves Human Lymphatic Fluid Transport a Translational Trial

Actual Study Start Date :

Jul 1, 2020

Actual Primary Completion Date :

Mar 26, 2021

Actual Study Completion Date :

Mar 26, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: Healthy participant day 1	Drug: Saline infusion Saline Infusion
Other: Healthy participan day 2	Drug: Octreotide Injection Octreotide infusion

Arm

Intervention/Treatment

Other: Healthy participant day 1

Drug: Saline infusion

Saline Infusion

Other: Healthy participan day 2

Drug: Octreotide Injection

Octreotide infusion

Outcome Measures

Primary Outcome Measures

Lymph rate [During infusion]
Propulsions /minute
Lymph Pressure [During infusion]
mmHg assessed by near-infra flourescence imaging
Capillary filtration rate [During infusion]
assessed by plethysmography
Capillary filtration coefficency [During infusion]
assessed by plethysmography
Isovolumetric pressure [During infusion]
assessed by plethysmography

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rigshospitalet	København Ø		Denmark	2100

Sponsors and Collaborators

Rigshospitalet, Denmark
University of Aarhus
Bispebjerg Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Thomas Holm-Weber, MD, Rigshospitalet, Denmark

ClinicalTrials.gov Identifier:

NCT05683444

Other Study ID Numbers:

P-2020-592

First Posted:

Jan 13, 2023

Last Update Posted:

Jan 13, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Chylothorax

Lymphatic Diseases

Octreotide

Study Results

No Results Posted as of Jan 13, 2023