NCT04855786

Brief Summary

To demonstrate that external drainage of thoracic duct lymph during sepsis results in a reduction in circulating pro-inflammatory cytokines. To demonstrate safety and feasibility of early thoracic duct cannulation and external lymph drainage for up to 7 days in adult surgical intensive care patients. To explore other biochemical and physiological endpoints that can be used for the design of future randomized controlled trials and estimate effect size of external drainage.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable sepsis

Timeline
26mo left

Started Jan 2026

Typical duration for not_applicable sepsis

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Jan 2026Jul 2028

First Submitted

Initial submission to the registry

April 20, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 22, 2021

Completed
4.7 years until next milestone

Study Start

First participant enrolled

January 4, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

1.5 years

First QC Date

April 20, 2021

Last Update Submit

February 16, 2026

Conditions

SepsisSeptic Shock

Keywords

inflammatory cytokinesLymphatic drainagethoracic ductSepsis

Outcome Measures

Primary Outcomes (1)

  • Reduction in circulating pro-inflammatory cytokines

    serial assays of lymph and plasma to measure inflammatory cytokines

    over 7 days of drainage

Study Arms (1)

Thoracic Duct Drainage

EXPERIMENTAL

This is the main study group of patients with thoracic duct drainage

Procedure: Thoracic duct drainage

Interventions

Thoracic duct drainagePROCEDURE

drain placement into the thoracic duct

Thoracic Duct Drainage

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult (18-80 years) patients in Surgical ICU with suspected or documented infection on antibiotics and septic shock defined as hypotension requiring vasopressor therapy to maintain MAP \> 65mmHg (modified from Sepsis-35).
  • The patient will not be recruited if he or she no longer meet these criteria.
  • Patients experiencing hemodynamic instability, defined as (1) MAPs \< 65 despite ongoing up-titration of pressors and volume resuscitation or (2) active titration of vasopressors (more than 2 increases in past hour) or active volume resuscitation (more than 1-liter bolus in past hour) that precludes travel to IR during the intervention window will be excluded from the study and considered screen fails

You may not qualify if:

  • Open abdomen
  • Intra-abdominal sepsis preventing access to the lymphatic system
  • Prior instrumentation of the lymphatic system
  • Known occlusion of the left subclavian vein
  • Known malformation of the lymphatic system
  • Previous left axillary node dissection ± left upper limb lymphoedema
  • Class 4 heart failure
  • Any chronic medical condition for which the patient is expected to have \<6-month survival
  • Decompensated liver failure with ascites
  • Portal hypertension with history of variceal bleeding
  • Severe allergy to contrast agents
  • Need for continuous anticoagulation (that cannot be stopped for procedure)
  • Uncorrectable coagulopathy or INR \>1.5
  • Uncorrectable thrombocytopenia (platelet count less than 50,000)
  • Immunocompromised state (active cytotoxic chemotherapy or transplant recipient)
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

SepsisShock, Septic

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Niels D Martin, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Niels D Martin, MD

CONTACT

215-662-7323niels.martin@pennmedicine.upenn.edu

Seema Anandalwar, MD

CONTACT

215-662-7323seema.anandalwar@pennmedicine.upenn.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2021

First Posted

April 22, 2021

Study Start

January 4, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2028

Last Updated

February 18, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)