Thoracic Duct Drainage for Septic Shock

Recruiting in Palo Alto (17 mi)

Overseen byNiels D Martin, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Pennsylvania

No Placebo Group

Trial Summary

What is the purpose of this trial?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

This trial is for adults aged 18-80 in the Surgical ICU with suspected or documented infection, on antibiotics, and septic shock needing vasopressors to maintain blood pressure. Excluded are those with severe bleeding risks, compromised immune systems, certain heart/liver conditions, pregnancy, or inability to consent.

Inclusion Criteria

The patient will not be recruited if he or she no longer meet these criteria.

I am an adult in the ICU with an infection and septic shock, needing drugs to keep my blood pressure up.

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.

+1 more

Exclusion Criteria

I have an open wound in my abdomen.

I cannot have a central venous or arterial line placed.

You have a serious allergy to the dye used in medical imaging tests.

+16 more

Participant Groups

The study tests if draining lymph from the thoracic duct can lower harmful inflammation markers in septic shock patients. It involves early cannulation of the duct and drainage for up to a week while monitoring safety and other health indicators.

1Treatment groups

Experimental Treatment

Group I: Thoracic Duct DrainageExperimental Treatment1 Intervention

This is the main study group of patients with thoracic duct drainage