Recruiting

Thoracic Duct Drainage

Sponsor:

University of Pennsylvania

Code:

NCT04855786

Conditions

Sepsis

Septic Shock

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Thoracic duct drainage

Study Details

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.

Conditions

Sepsis

Septic Shock

Study ID

NCT04855786

Start date

Jan 4, 2026

Status verified date

Feb, 2026

Completion date

Jul 1, 2028

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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).

Participants will fulfill the inclusion criteria not only at recruitment and consent, but also be confirmed to still meet those criteria immediately prior to transfer to IR for the procedure.

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

Exclusion Criteria:

1. Open abdomen
2. Intra-abdominal sepsis preventing access to the lymphatic system
3. Prior instrumentation of the lymphatic system
4. Known occlusion of the left subclavian vein
5. Known malformation of the lymphatic system
6. Previous left axillary node dissection ± left upper limb lymphoedema
7. Class 4 heart failure
8. Any chronic medical condition for which the patient is expected to have <6-month survival
9. Decompensated liver failure with ascites
10. Portal hypertension with history of variceal bleeding
11. Severe allergy to contrast agents
12. Need for continuous anticoagulation (that cannot be stopped for procedure)
13. Uncorrectable coagulopathy or INR >1.5
14. Uncorrectable thrombocytopenia (platelet count less than 50,000)
15. Immunocompromised state (active cytotoxic chemotherapy or transplant recipient)
16. Pregnancy
17. DNR ('do not resuscitate') status
18. Subject or authorized representative not willing to provide consent (unconscious patient will need to countersign prior to analysis of samples)
19. Unable to have central venous line or arterial line in place

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Thoracic Duct Drainage

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

Interventions

Thoracic duct drainage

drain placement into the thoracic duct

Primary outcome measure

  • Reduction in circulating pro-inflammatory cytokines [ Time Frame: over 7 days of drainage ]

Central Contacts and Locations

Locations

Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Principal Investigator:

Niels Martin, MD

More Information

Sponsor

University of Pennsylvania

Last update posted

Feb 18, 2026

Last verified

Feb, 2026

Keywords

  • inflammatory cytokines
  • Lymphatic drainage
  • thoracic duct
  • Sepsis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-02-18.