Lymph drainage may cool overactive immune response in sepsis
NCT ID NCT04855786
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early study tests whether draining lymph fluid from the chest can lower harmful inflammation in people with septic shock. Ten adults in the surgical ICU will have a tube placed in their thoracic duct to drain lymph for up to 7 days. The goal is to see if this procedure is safe and can reduce inflammatory proteins in the blood.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
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A doctor treating you
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Contacts and locations
Locations
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Hospital of the University of Pennsylvania
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Bedside eye scans may reveal hidden blood flow problems in septic shock
- Can two blood markers catch sepsis before it turns deadly?
- Two cheap blood ratios put to the test as sepsis death predictors
- Can a bedside ultrasound predict which septic shock patients will stop breathing on their own?
- Can a computer model speed up sepsis blood tests?
- Stem cells put to the test against Sepsis's immune chaos