Draining thoracic duct lymph to lower inflammation in septic shock
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
NA · University of Pennsylvania · NCT04855786
This study will try draining lymph from the thoracic duct in adults with septic shock to see if it lowers harmful inflammatory cytokines in the blood.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Pennsylvania (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT04855786 on ClinicalTrials.gov |
What this trial studies
This is a pilot interventional cohort in surgical ICU patients with septic shock using early thoracic duct cannulation and external lymph drainage for up to seven days. Lymph and matched blood samples will be collected periodically to measure pro-inflammatory cytokines and other biochemical markers. Researchers will correlate changes in lymph and blood composition with patient physiology, disease severity, and clinical outcomes. The study is primarily designed to test safety, feasibility, and to estimate effect sizes for future randomized trials and is not powered to detect differences in ICU stay or mortality.
Who should consider this trial
Good fit: Adults aged 18–80 in the surgical ICU with suspected or documented infection on antibiotics and septic shock requiring vasopressors to maintain MAP >65 mmHg who remain stable enough to be transferred to interventional radiology are eligible.
Not a fit: Patients who are hemodynamically unstable (unable to tolerate transfer or ongoing active resuscitation), have an open abdomen, or have intra-abdominal sepsis that prevents the procedure are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, external lymph drainage could lower circulating inflammatory cytokines and potentially reduce organ injury during septic shock.
How similar studies have performed: This approach is largely novel in humans: preclinical data and limited clinical reports suggest lymph removal can modify inflammatory mediators but randomized human evidence is lacking.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Philadelphia, Pennsylvania
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (RECRUITING)
Study contacts
- Principal investigator: Niels D Martin, MD — University of Pennsylvania
- Study coordinator: Niels D Martin, MD
- Email: niels.martin@pennmedicine.upenn.edu
- Phone: 215-662-7323
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sepsis, Septic Shock, inflammatory cytokines, Lymphatic drainage, thoracic duct