NCT05683444

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Jul 2020

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2021

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 13, 2023

Completed
Last Updated

March 30, 2023

Status Verified

March 1, 2023

Enrollment Period

9 months

First QC Date

January 4, 2023

Last Update Submit

March 28, 2023

Conditions

Lymphatic DiseasesChylothorax

Outcome Measures

Primary Outcomes (5)

  • Lymph rate

    Propulsions /minute

    During infusion

  • Lymph Pressure

    mmHg assessed by near-infra fluorescence imaging

    During infusion

  • Capillary filtration rate

    assessed by plethysmography

    During infusion

  • Capillary filtration coefficiency

    assessed by plethysmography

    During infusion

  • Isovolumetric pressure

    assessed by plethysmography

    During infusion

Study Arms (2)

Healthy participant 1

OTHER
Drug: Octreotide infusionDrug: Saline infusion

Healthy participant 2

OTHER
Drug: Octreotide infusionDrug: Saline infusion

Interventions

Octreotide infusionDRUG

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.

Healthy participant 1Healthy participant 2
Saline infusionDRUG

Saline Infusion

Healthy participant 1Healthy participant 2

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \* Healthy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

København Ø, 2100, Denmark

Location

MeSH Terms

Conditions

Lymphatic DiseasesChylothorax

Condition Hierarchy (Ancestors)

Hemic and Lymphatic DiseasesPleural DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Double-blinded cross over study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor, Principal Investigator

Study Record Dates

First Submitted

January 4, 2023

First Posted

January 13, 2023

Study Start

July 1, 2020

Primary Completion

March 26, 2021

Study Completion

March 26, 2021

Last Updated

March 30, 2023

Record last verified: 2023-03

Locations

DK(1)