Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT04855786

External Drainage of Thoracic Duct Lymph to Reduce Inflammatory Cytokines in Septic Shock Patients

Led by University of Pennsylvania · Updated on 2026-02-18

10

Participants Needed

1

Research Sites

129 weeks

Total Duration

On this page

Sponsors

U

University of Pennsylvania

Lead Sponsor

H

Health Research Council, New Zealand

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

External Drainage of Thoracic Duct Lymph to Reduce Inflammatory Cytokines in Septic Shock Patients

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients aged 18 to 80 years
  • Currently in Surgical ICU with suspected or documented infection
  • Receiving antibiotics
  • Experiencing septic shock defined as low blood pressure requiring vasopressors to maintain MAP > 65 mmHg
  • Meeting inclusion criteria at recruitment and immediately before the drainage procedure
  • Able to be safely transferred to Interventional Radiology for the procedure without hemodynamic instability
Not Eligible

You will not qualify if you...

  • Open abdomen or recent open abdominal surgery
  • Intra-abdominal sepsis preventing access to the lymphatic system
  • Prior instrumentation of the lymphatic system
  • Known blockage of the left subclavian vein
  • Known malformation of the lymphatic system
  • Previous left axillary node surgery or left upper limb lymphedema
  • Class 4 heart failure
  • Chronic medical conditions with expected survival less than 6 months
  • 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 blood clotting problems (INR > 1.5 or platelet count < 50,000)
  • Immunocompromised state such as active chemotherapy or transplant recipient
  • Pregnancy
  • Do Not Resuscitate status
  • Unwilling or unable to provide consent
  • Unable to have central venous or arterial lines placed safely

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

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Research Team

N

Niels D Martin, MD

CONTACT

S

Seema Anandalwar, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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