Lymphatic DiseasesEarly Phase 1NCT05683444
Octreotide Improves Human Lymphatic Fluid Transport a Translational Trial
A Early Phase 1 study testing Octreotide infusion and Saline infusion in people with Lymphatic Diseases and Chylothorax, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Lymphatic Diseases, Chylothorax
- What is being tested?
- Octreotide infusion and Saline infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jul 2020to 26 Mar 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
Who cannot join
- No daily medication (except birth control), or allergies towards contrast agents.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Lymphatic Diseases, Chylothorax
- Being tested
- Octreotide infusion, Saline infusion
- Medical subject headings
- Lymphatic Diseases, Chylothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Saline infusionDrug
Saline Infusion
| Study group | Role | What they receive |
|---|---|---|
| Healthy participant 1 | Other | Not described Receives: Drug: Octreotide infusion; Drug: Saline infusion |
| Healthy participant 2 | Other | Not described Receives: Drug: Octreotide infusion; Drug: Saline infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymph rate
Propulsions /minute
Measured: During infusion
Lymph Pressure
mmHg assessed by near-infra fluorescence imaging
Measured: During infusion
Capillary filtration rate
assessed by plethysmography
Measured: During infusion
Capillary filtration coefficiency
assessed by plethysmography
Measured: During infusion
Isovolumetric pressure
assessed by plethysmography
Measured: During infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start1 Jul 2020
- Primary completion26 Mar 2021
- Study completion26 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphatic DiseasesStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double-blinded cross over study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus, Bispebjerg Hospital
- Responsible party
- Principal investigator, Thomas Holm-Weber, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05683444
- Sponsor's protocol ID
- P-2020-592
- Status last verified
- Mar 2023
- First submitted
- 4 Jan 2023
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Octreotide Improves Human Lymphatic Fluid Transport a Translational Trial
- ClinicalTrials.gov ID
- NCT05683444
- Acronym / sponsor ID
- P-2020-592
- Conditions
- Lymphatic Diseases, Chylothorax
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- University of Aarhus, Bispebjerg Hospital
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 26 Mar 2021 (actual)
- Study completion
- 26 Mar 2021 (actual)
- First posted
- 13 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blinded cross over study
| Arm | Type | Receives |
|---|---|---|
| Healthy participant 1 | Other | Drug: Octreotide infusion, Drug: Saline infusion |
| Healthy participant 2 | Other | Drug: Octreotide infusion, Drug: Saline infusion |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy
Key exclusion criteria (1 listed)
- No daily medication (except birth control), or allergies towards contrast agents.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Octreotide infusionOctreotide 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. | Drug | Healthy participant 1, Healthy participant 2 |
| Saline infusionSaline Infusion | Drug | Healthy participant 1, Healthy participant 2 |
Primary outcome
Lymph rate
Time frame: During infusion
Propulsions /minute
Lymph Pressure
Time frame: During infusion
mmHg assessed by near-infra fluorescence imaging
Capillary filtration rate
Time frame: During infusion
assessed by plethysmography
Capillary filtration coefficiency
Time frame: During infusion
assessed by plethysmography
Isovolumetric pressure
Time frame: During infusion
assessed by plethysmography
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Octreotide infusion and Saline infusion in people with Lymphatic Diseases and Chylothorax, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lymph rate (time frame: During infusion). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2023.