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Recruiting NCT04855786

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

Trial Parameters

Condition Sepsis
Sponsor University of Pennsylvania
Study Type INTERVENTIONAL
Phase N/A
Enrollment 10
Sex ALL
Min Age 18 Years
Max Age 80 Years
Start Date 2026-01-04
Completion 2027-07-01
Interventions
Thoracic duct drainage

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 t

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