Draining thoracic duct lymph to lower inflammation in septic shock

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.