Thoracic Duct Drainage for Septic Shock

Overseen By Joy Steele, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Must be taking: Antibiotics, Vasopressors

Must not be taking: Continuous anticoagulants

Disqualifiers: Open abdomen, Heart failure, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 7 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether draining lymph fluid from the thoracic duct, a large lymphatic vessel, can reduce harmful inflammation during septic shock, a serious condition where infection causes dangerously low blood pressure. Researchers aim to determine if this procedure is safe and feasible for early intervention in patients with sepsis. They are also exploring additional benefits to guide future studies. Suitable candidates have an infection causing low blood pressure that requires medication to maintain normal levels and are in a surgical intensive care unit. As an unphased trial, this study offers patients the opportunity to contribute to groundbreaking research that could enhance future sepsis treatments.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that patients who need continuous anticoagulation (blood thinners) that cannot be stopped for the procedure are excluded. It's best to discuss your specific medications with the trial team.

What prior data suggests that thoracic duct drainage is safe for septic shock patients?

Research has shown that thoracic duct drainage, a procedure to remove lymph fluid, is generally safe. A review of studies found this treatment particularly safe when combined with lymphosorption. The research indicated that the benefits often matched the amount of fluid removed. However, related procedures like thoracentesis, which involves using a needle to remove fluid from the chest, carry a risk of toxic shock syndrome, a serious reaction. Symptoms to watch for include fever, rash, vomiting, and diarrhea. Overall, the treatment appears well-tolerated, but like any medical procedure, it carries risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Thoracic duct drainage is unique because it offers a novel approach to managing septic shock by directly removing inflammatory substances and toxins from the lymphatic system. Traditional treatments for septic shock usually focus on antibiotics and supportive care, like fluids and vasopressors, to stabilize patients. However, this method targets the root cause by clearing harmful agents from the body, potentially leading to quicker and more effective recovery. Researchers are excited about this treatment because it could change how we manage septic shock, providing a more direct way to alleviate the body's inflammatory response.

What evidence suggests that thoracic duct drainage is effective for septic shock?

Research has shown that draining fluid from the thoracic duct, part of the lymphatic system, may help reduce inflammation in people with septic shock. This fluid, called lymph, contains white blood cells. Draining it can lower levels of harmful proteins known as pro-inflammatory cytokines, potentially calming the body's inflammatory response. Other studies suggest this method could also improve fluid management and immune system signaling. Although more research is needed, early results are promising and indicate that thoracic duct drainage, which participants in this trial will receive, could be a useful treatment for septic shock. ^{1 3 4 5 6}

Who Is on the Research Team?

Niels D Martin, MD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 in the Surgical ICU with suspected or documented infection, on antibiotics, and septic shock needing vasopressors to maintain blood pressure. Excluded are those with severe bleeding risks, compromised immune systems, certain heart/liver conditions, pregnancy, or inability to consent.

Inclusion Criteria

The patient will not be recruited if he or she no longer meet these criteria.

I am an adult in the ICU with an infection and septic shock, needing drugs to keep my blood pressure up.

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.

Exclusion Criteria

I have an open wound in my abdomen.

I cannot have a central venous or arterial line placed.

You have a serious allergy to the dye used in medical imaging tests.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

External drainage of thoracic duct lymph for up to 7 days in septic shock patients

7 days

Daily monitoring in ICU

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Thoracic duct drainage

Trial Overview The study tests if draining lymph from the thoracic duct can lower harmful inflammation markers in septic shock patients. It involves early cannulation of the duct and drainage for up to a week while monitoring safety and other health indicators.

How Is the Trial Designed?

Group I: Thoracic Duct Drainage Experimental Treatment 1 Intervention

This is the main study group of patients with thoracic duct drainage

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

University of Auckland, New Zealand

Collaborator

Trials

82

Recruited

372,000+

Health Research Council, New Zealand

Collaborator

Trials

18

Recruited

25,900+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04855786

External Drainage of Thoracic Duct Lymph to Reduce ... To demonstrate that external drainage of thoracic duct lymph during sepsis results in a reduction in circulating pro-inflammatory cytokines. To demonstrate ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0306987720302784

Lymphatic flow modulation as adjunct therapy for septic ... Modulation of the lymphatic system during septic shock may decrease interstitial fluid volume resulting in improved solute exchange, immune signaling, and ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7596461/

Mesenteric Lymph Duct Drainage Attenuates Lung ... Mesenteric lymph duct drainage significantly attenuated lung inflammatory injury by decreasing the expression of pivotal inflammatory mediators and inhibiting ...

4. researchgate.net researchgate.net/publication/365871891_Therapeutic_thoracic_duct_drainage_A_systematic_review_of_the_Eastern_European_experience_and_future_potential

(PDF) Therapeutic thoracic duct drainage: A systematic ... Human TDD appeared safe and probably effective, especially when combined with lymphosorption. The benefit appeared to correlate with the volume ...

5. researchspace.auckland.ac.nz researchspace.auckland.ac.nz/bitstreams/71bb88b9-ce30-444f-a37f-0b96ce7f748a/download

THERAPEUTIC THORACIC DUCT DRAINAGE External drainage of thoracic duct lymph to reduce inflammatory cytokines in septic shock patients (ClinicalTrials.gov identifier: NCT04855786). https ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40661331/

Toxic Shock Syndrome Triggered by Thoracic Drain Insertion TSS can occur after simple, routine procedures such as thoracentesis. Symptoms such as fever, rash, vomiting, and diarrhea should raise concern for TSS.