What this study is
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.
What's being tested
- Thoracic duct drainage
Intervention · PROCEDURE
drain placement into the thoracic duct
Study details
- Official title
- External Drainage of Thoracic Duct Lymph to Reduce Inflammatory Cytokines in Septic Shock Patients: A Pilot Trial With Concurrent Controls to Confirm Safety and Assess Preliminary Efficacy
- Sponsor
- University of Pennsylvania
- Conditions
- Sepsis · Septic Shock
- Enrolling
- 10 people
- Starts
- 2026-01-04
- Est. completion
- 2028-07-01
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 80 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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)
- Pregnancy
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openHospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
- Niels D Martin, MD · Contact215-662-7320niels.martin@pennmedicine.upenn.edu
- Seema Anandalwar, MD · Contact215-662-7320seema.anandalwar@pennmedicine.upenn.edu
- Niels Martin, MD · Principal investigator
Recruiting
Study team
Sponsor
University of Pennsylvania
Study ID 834599
Principal investigator
Niels D Martin, MD
University of Pennsylvania
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.