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Lymph drainage may cool overactive immune response in sepsis

NCT ID NCT04855786

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Hospital of the University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

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