External Drainage of Thoracic Duct Lymph to Reduce Inflammatory Cytokines in Septic Shock Patients

External Drainage of Thoracic Duct Lymph to Reduce Inflammatory Cytokines in Septic Shock Patients: A Pilot Trial With Concurrent Controls to Confirm Safety and Assess Preliminary Efficacy

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04855786

Enrollment

Registered

2021-04-22

Start date

2026-01-04

Completion date

2028-07-01

Last updated

2026-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis, Septic Shock

Keywords

inflammatory cytokines, Lymphatic drainage, thoracic duct, Sepsis

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.

Detailed description

This is an interventional cohort study that will involve external drainage of thoracic duct lymph in Surgical ICU patients with septic shock. The lymph drainage will continue for up to a maximum of 7 days and will be continued in those interventional group patients discharged from ICU back to the ward before that time. The lymph (and time-matched blood) will be periodically sampled to detect changes in composition which will be correlated with changes in disease severity and outcomes, as well as patient physiology and biochemistry. This pilot study is not powered to detect changes in hospital/ICU stay, major complications or mortality. The primary endpoint of interest is the pro-inflammatory cytokine profile and concentrations in lymph and peripheral blood.

Interventions

PROCEDUREThoracic duct drainage

drain placement into the thoracic duct

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Reduction in circulating pro-inflammatory cytokines	over 7 days of drainage	serial assays of lymph and plasma to measure inflammatory cytokines

Countries

United States

Contacts

CONTACTNiels D Martin, MD

niels.martin@pennmedicine.upenn.edu215-662-7323

CONTACTSeema Anandalwar, MD

seema.anandalwar@pennmedicine.upenn.edu215-662-7323

PRINCIPAL_INVESTIGATORNiels D Martin, MD

University of Pennsylvania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026