Octreotide Improves Human Lymphatic Fluid Transport a Translational Trial

Lymphatic Diseases Clinical Trial

Official title:

Octreotide Improves Human Lymphatic Fluid Transport a Translational Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05683444
• Other study ID #: P-2020-592
• Status: Completed
• Phase: Early Phase 1
• Start date: July 1, 2020
• Est. completion date: March 26, 2021

Study information

• Verified date: March 2023
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 26, 2021
• Est. primary completion date: March 26, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 35 Years

Eligibility

Inclusion Criteria:

• Healthy

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Chylothorax
• Lymphatic Diseases

Intervention

Drug:
• Octreotide 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.
• Saline infusion
Saline Infusion

Locations

Country	Name	City	State
Denmark	Rigshospitalet	København Ø

Sponsors (3)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Bispebjerg Hospital, University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lymph rate	Propulsions /minute	During infusion
Primary	Lymph Pressure	mmHg assessed by near-infra fluorescence imaging	During infusion
Primary	Capillary filtration rate	assessed by plethysmography	During infusion
Primary	Capillary filtration coefficiency	assessed by plethysmography	During infusion
Primary	Isovolumetric pressure	assessed by plethysmography	During infusion