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CompletedNCT05683444Updated Mar 30, 2023

Octreotide Improves Human Lymphatic Fluid Transport a Translational Trial

An Early Phase 1 interventional study of Octreotide infusion and Saline infusion in Lymphatic Diseases and Chylothorax, sponsored by Rigshospitalet, Denmark. Completed at 1 site in Denmark. Open to participants aged 20 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-30.

Sponsored by Rigshospitalet, Denmark · Early Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 6 months after the study started (first participant enrolled Jul 2020, registered Jan 2023).
Phase
Early Phase 1
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
20 Years to 35 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Lymphatic Diseases
  • Chylothorax

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03

In context

Lymphatic Diseases

47 studies on the registry are indexed under Lymphatic Diseases; 11 are open to participants now.

This study's enrollment of 16 is below the median of 30 across 31 interventional studies indexed under Lymphatic Diseases.

Browse Lymphatic Diseases studies →

Lead sponsor

Rigshospitalet, Denmark is the lead sponsor of 1,017 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

* Healthy

Exclusion criteria

Exclusion Criteria:

  • No daily medication (except birth control), or allergies towards contrast agents.
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
16 participants (actual)

Study arms

  • Other
    Healthy participant 1

    Drug: Octreotide infusion · Drug: Saline infusion

  • Other
    Healthy participant 2

    Drug: Octreotide infusion · Drug: Saline infusion

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

06

What researchers measure

Primary outcomes

  1. Lymph rate

    Propulsions /minute

    Time frame: During infusion

  2. Lymph Pressure

    mmHg assessed by near-infra fluorescence imaging

    Time frame: During infusion

  3. Capillary filtration rate

    assessed by plethysmography

    Time frame: During infusion

  4. Capillary filtration coefficiency

    assessed by plethysmography

    Time frame: During infusion

  5. Isovolumetric pressure

    assessed by plethysmography

    Time frame: During infusion

07

Study locations

1 site
  • Rigshospitalet
    København Ø, 2100, Denmark
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05683444
Lead sponsor
Rigshospitalet, Denmark
Collaborators
University of Aarhus, Bispebjerg Hospital
Responsible party
Thomas Holm-Weber (Medical Doctor, Principal Investigator, Rigshospitalet, Denmark) — Principal investigator
First posted
Jan 13, 2023
Start date
Jul 1, 2020
Primary completion
Mar 26, 2021
Completion
Mar 26, 2021
Last update
Mar 30, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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