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Procedure

Thoracic Duct Drainage for Septic Shock

N/A
Waitlist Available
Led By Niels D Martin, MD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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).
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
Must not have
Open abdomen
Unable to have central venous line or arterial line in place
Timeline
Screening 3 weeks
Treatment Varies
Follow Up over 7 days of drainage
Awards & highlights
No Placebo-Only Group

Summary

This trial shows that early thoracic duct cannulation and external lymph drainage may help reduce pro-inflammatory cytokines in adult surgical intensive care patients.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include complications from catheter placement such as infection or damage to nearby structures; allergic reactions to contrast agents used during procedures; and issues related to prolonged bed rest.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am an adult in the ICU with an infection and septic shock, needing drugs to keep my blood pressure up.
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I am stable and do not need constant medication adjustments or large fluid boosts.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an open wound in my abdomen.
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I cannot have a central venous or arterial line placed.
Select...
I have high blood pressure in the liver veins and have had bleeding from enlarged veins.
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I have an infection in my abdomen that affects access to my lymphatic system.
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I am currently immunocompromised due to chemotherapy or after receiving a transplant.
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I have a blockage in the main vein on the left side of my neck.
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I had surgery to remove lymph nodes under my left arm, and may have swelling in my left arm.
Select...
I need to take blood thinners that can't be stopped for any procedure.
Select...
I have severe liver failure with fluid buildup in my abdomen.
Select...
I have a chronic illness with an expected survival of less than 6 months.
Select...
I have severe heart failure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over 7 days of drainage
This trial's timeline: 3 weeks for screening, Varies for treatment, and over 7 days of drainage for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Reduction in circulating pro-inflammatory cytokines

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Thoracic Duct DrainageExperimental Treatment1 Intervention
This is the main study group of patients with thoracic duct drainage

Find a Location

Who is running the clinical trial?

University of Auckland, New ZealandOTHER
75 Previous Clinical Trials
120,364 Total Patients Enrolled
University of PennsylvaniaLead Sponsor
2,073 Previous Clinical Trials
42,714,348 Total Patients Enrolled
4 Trials studying Sepsis
102,695 Patients Enrolled for Sepsis
Health Research Council, New ZealandOTHER
17 Previous Clinical Trials
25,854 Total Patients Enrolled

Media Library

Thoracic duct drainage (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04855786 — N/A
Sepsis Research Study Groups: Thoracic Duct Drainage
Sepsis Clinical Trial 2023: Thoracic duct drainage Highlights & Side Effects. Trial Name: NCT04855786 — N/A
Thoracic duct drainage (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04855786 — N/A
~0 spots leftby Dec 2024
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