NCT04855786 · University of Pennsylvania
External Drainage of Thoracic Duct Lymph to Reduce Inflammatory Cytokines in Septic Shock Patients
What this study is about
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.
View original scientific description
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.
Interventions
PROCEDURE
Thoracic duct drainage
drain placement into the thoracic duct
Primary outcome measures
Reduction in circulating pro-inflammatory cytokines
Time frame: over 7 days of drainage
serial assays of lymph and plasma to measure inflammatory cytokines
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Open abdomen
- Intra-abdominal sepsis preventing access to the lymphatic system
- Prior instrumentation of the lymphatic system
- Known occlusion of the left subclavian vein
- Known malformation of the lymphatic system
- Previous left axillary node dissection ± left upper limb lymphoedema
- Class 4 heart failure
- Any chronic medical condition for which the patient is expected to have \<6-month survival
- Decompensated liver failure with ascites
- Portal hypertension with history of variceal bleeding
- Severe allergy to contrast agents
- Need for continuous anticoagulation (that cannot be stopped for procedure)
- Uncorrectable coagulopathy or INR \>1.5
- Uncorrectable thrombocytopenia (platelet count less than 50,000)
- Immunocompromised state (active cytotoxic chemotherapy or transplant recipient)
- DNR ('do not resuscitate') status
- Subject or authorized representative not willing to provide consent (unconscious patient will need to countersign prior to analysis of samples)
- Unable to have central venous line or arterial line in place
Where
- Philadelphia, Pennsylvania
Collaborators
Health Research Council, New Zealand, University of Auckland, New Zealand
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 18, 2026 · Source of record for eligibility and locations