Octreotide Improves Human Lymphatic Fluid Transport a Tra... | NCT05683444

Studies
Octreotide Improves Human Lymphatic Fluid Transport a Translational Trial

NCT05683444

Sponsor

Rigshospitalet, Denmark

Status

Completed

Last Update Posted

Mar 30, 2023Actual

Enrollment

16Actual

Phase

Early Phase 1

Conditions

Lymphatic Diseases
Chylothorax

Interventions

Octreotide infusion
Saline infusion

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2020Actual

Primary Completion Date

Mar 26, 2021Actual

Completion Date

Mar 26, 2021Actual

First Submitted Date

Jan 4, 2023

First Submission Date that Met QC Criteria

Jan 4, 2023

First Posted Date

Jan 13, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 28, 2023

Last Update Posted Date

Mar 30, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Thomas Holm-Weber, Medical Doctor, Principal Investigator, Rigshospitalet, DenmarkPrincipal Investigator

Lead Sponsor

Rigshospitalet, DenmarkOTHER

Collaborators

Name	Class
University of Aarhus	OTHER
Bispebjerg Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy participant 1	Other		Drug: Octreotide infusion Drug: Saline infusion
Healthy participant 2	Other		Drug: Octreotide infusion Drug: Saline infusion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Octreotide infusion	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

* Healthy

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rigshospitalet		København Ø		2100	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008206	Lymphatic Diseases
D002916	Chylothorax

Ancestor Terms

ID	Term
D006425	Hemic and Lymphatic Diseases
D010995	Pleural Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

Triple

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.

Who Masked

ParticipantInvestigatorOutcomes Assessor