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

10 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

How is thoracic duct drainage different from other treatments for septic shock?

Thoracic duct drainage is unique because it involves physically draining lymphatic fluid from the thoracic duct, which is different from standard treatments like fluid resuscitation and antibiotics that focus on managing symptoms and infections. This approach may help remove inflammatory substances from the body, offering a novel way to address the underlying causes of septic shock. ^{1 2 3 4 5}

Research Team

Niels D Martin, MD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Treatment priorities for septic shock. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Unanswered questions on the use of hydrocortisone, ascorbic acid, and thiamine therapy in sepsis and septic shock. [2022]

3. France pubmed.ncbi.nlm.nih.gov

[Latest treatments for septic shock and the current state of research]. [2020]

4. Italy pubmed.ncbi.nlm.nih.gov

High-volume hemofiltration combined with early goal-directed therapy improves alveolar-arterial oxygen exchange in patients with refractory septic shock. [2018]

5. Germany pubmed.ncbi.nlm.nih.gov

[Targeted cardiovascular therapy: shock treatment in ambulance, emergency room and intensive care unit]. [2018]