NCT04855786 External Drainage of Thoracic Duct Lymph to Reduce Inflammatory Cytokines in Septic Shock Patients
| NCT ID | NCT04855786 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pennsylvania |
| Condition | Sepsis |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2026-01-04 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2026-01-04 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Niels D Martin, MD
PRINCIPAL INVESTIGATOR
University of Pennsylvania
Frequently Asked Questions
Who can join the NCT04855786 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Sepsis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04855786 currently recruiting?
Yes, NCT04855786 is actively recruiting participants. Contact the research team at niels.martin@pennmedicine.upenn.edu for enrollment information.
Where is the NCT04855786 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT04855786 clinical trial?
NCT04855786 is sponsored by University of Pennsylvania. The principal investigator is Niels D Martin, MD at University of Pennsylvania. The trial plans to enroll 10 participants.