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

Launched by UNIVERSITY OF PENNSYLVANIA · Apr 20, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment for patients who are experiencing septic shock, a serious condition caused by infections that can lead to dangerously low blood pressure. The trial aims to see if draining a specific type of fluid from the body, called thoracic duct lymph, can help reduce harmful substances in the blood that contribute to inflammation during sepsis. Researchers want to find out if this procedure is safe and practical for patients in the surgical intensive care unit, as well as gather information that could help in designing future studies.

To be eligible for this trial, patients must be adults aged 18 to 80 who are receiving antibiotics for an infection and are experiencing septic shock, meaning they need medication to maintain their blood pressure. However, certain patients will not be eligible, such as those with specific medical conditions or complications. Participants can expect to have a procedure that involves draining lymph fluid for up to seven days, and the study will monitor their health closely during this time. This research could potentially lead to new treatments that improve outcomes for patients facing severe infections.

Gender

ALL

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