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RECRUITING

NCT04855786

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

Sponsor: University of Pennsylvania

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-01-04

Completion Date

2028-07-01

Last Updated

2026-02-18

Healthy Volunteers

Conditions

Sepsis Septic Shock

Interventions

PROCEDURE

Thoracic duct drainage

drain placement into the thoracic duct

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

Locations (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States