Back to resultsOctreotide Improves Human Lymphatic Fluid Transport a Translational Trial
Primary Purpose
Lymphatic Diseases, Chylothorax
Status
Completed
Phase
Early Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Octreotide infusion
Saline infusion
Sponsored by
About this trial
This is an interventional treatment trial for Lymphatic Diseases
Eligibility Criteria
Inclusion Criteria: * Healthy Exclusion Criteria: No daily medication (except birth control), or allergies towards contrast agents.
Sites / Locations
- Rigshospitalet
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Healthy participant 1
Healthy participant 2
Arm Description
Outcomes
Primary Outcome Measures
Lymph rate
Propulsions /minute
Lymph Pressure
mmHg assessed by near-infra fluorescence imaging
Capillary filtration rate
assessed by plethysmography
Capillary filtration coefficiency
assessed by plethysmography
Isovolumetric pressure
assessed by plethysmography
Secondary Outcome Measures
Full Information
NCT ID
NCT05683444
First Posted
January 4, 2023
Last Updated
March 28, 2023
Sponsor
Rigshospitalet, Denmark
Collaborators
University of Aarhus, Bispebjerg Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05683444
Brief Title
Octreotide Improves Human Lymphatic Fluid Transport a Translational Trial
Official Title
Octreotide Improves Human Lymphatic Fluid Transport a Translational Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
March 26, 2021 (Actual)
Study Completion Date
March 26, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
University of Aarhus, Bispebjerg Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphatic Diseases, Chylothorax
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Model Description
Double-blinded cross over study
Masking
ParticipantInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy participant 1
Arm Type
Other
Arm Title
Healthy participant 2
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Octreotide infusion
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Saline infusion
Intervention Description
Saline Infusion
Primary Outcome Measure Information:
Title
Lymph rate
Description
Propulsions /minute
Time Frame
During infusion
Title
Lymph Pressure
Description
mmHg assessed by near-infra fluorescence imaging
Time Frame
During infusion
Title
Capillary filtration rate
Description
assessed by plethysmography
Time Frame
During infusion
Title
Capillary filtration coefficiency
Description
assessed by plethysmography
Time Frame
During infusion
Title
Isovolumetric pressure
Description
assessed by plethysmography
Time Frame
During infusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
* Healthy
Exclusion Criteria:
No daily medication (except birth control), or allergies towards contrast agents.
Facility Information:
Facility Name
Rigshospitalet
City
København Ø
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Octreotide Improves Human Lymphatic Fluid Transport a Translational Trial
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