Back to resultsExternal Drainage of Thoracic Duct Lymph to Reduce Inflammatory Cytokines in Septic Shock Patients
Primary Purpose
Sepsis, Septic Shock
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Thoracic duct drainage
Sponsored by
About this trial
This is an interventional treatment trial for Sepsis focused on measuring inflammatory cytokines, Lymphatic drainage, thoracic duct, Sepsis
Eligibility Criteria
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:
- Open abdomen
- Intra-abdominal sepsis preventing access to the lymphatic system
- Prior instrumentation of the lymphatic system
- Known occlusion of the left subclavian vein
- Known malformation of the lymphatic system
- Previous left axillary node dissection ± left upper limb lymphoedema
- Class 4 heart failure
- Any chronic medical condition for which the patient is expected to have <6-month survival
- 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 coagulopathy or INR >1.5
- Uncorrectable thrombocytopenia (platelet count less than 50,000)
- Immunocompromised state (active cytotoxic chemotherapy or transplant recipient)
- Pregnancy
- DNR ('do not resuscitate') status
- Subject or authorized representative not willing to provide consent (unconscious patient will need to countersign prior to analysis of samples)
- Unable to have central venous line or arterial line in place
Sites / Locations
- University of PennsylvaniaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Thoracic Duct Drainage
Arm Description
This is the main study group of patients with thoracic duct drainage
Outcomes
Primary Outcome Measures
Reduction in circulating pro-inflammatory cytokines
serial assays of lymph and plasma to measure inflammatory cytokines
Secondary Outcome Measures
Full Information
NCT ID
NCT04855786
First Posted
April 20, 2021
Last Updated
December 5, 2022
Sponsor
University of Pennsylvania
Collaborators
Health Research Council, New Zealand, University of Auckland, New Zealand
1. Study Identification
Unique Protocol Identification Number
NCT04855786
Brief Title
External Drainage of Thoracic Duct Lymph to Reduce Inflammatory Cytokines in Septic Shock Patients
Official Title
External Drainage of Thoracic Duct Lymph to Reduce Inflammatory Cytokines in Septic Shock Patients: A Pilot Trial With Concurrent Controls to Confirm Safety and Assess Preliminary Efficacy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 13, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Health Research Council, New Zealand, University of Auckland, New Zealand
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
This is an interventional cohort study that will involve external drainage of thoracic duct lymph in Surgical ICU patients with septic shock. The lymph drainage will continue for up to a maximum of 7 days and will be continued in those interventional group patients discharged from ICU back to the ward before that time. The lymph (and time-matched blood) will be periodically sampled to detect changes in composition which will be correlated with changes in disease severity and outcomes, as well as patient physiology and biochemistry. This pilot study is not powered to detect changes in hospital/ICU stay, major complications or mortality. The primary endpoint of interest is the pro-inflammatory cytokine profile and concentrations in lymph and peripheral blood.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Septic Shock
Keywords
inflammatory cytokines, Lymphatic drainage, thoracic duct, Sepsis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Thoracic Duct Drainage
Arm Type
Experimental
Arm Description
This is the main study group of patients with thoracic duct drainage
Intervention Type
Procedure
Intervention Name(s)
Thoracic duct drainage
Intervention Description
drain placement into the thoracic duct
Primary Outcome Measure Information:
Title
Reduction in circulating pro-inflammatory cytokines
Description
serial assays of lymph and plasma to measure inflammatory cytokines
Time Frame
over 7 days of drainage
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Open abdomen
Intra-abdominal sepsis preventing access to the lymphatic system
Prior instrumentation of the lymphatic system
Known occlusion of the left subclavian vein
Known malformation of the lymphatic system
Previous left axillary node dissection ± left upper limb lymphoedema
Class 4 heart failure
Any chronic medical condition for which the patient is expected to have <6-month survival
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 coagulopathy or INR >1.5
Uncorrectable thrombocytopenia (platelet count less than 50,000)
Immunocompromised state (active cytotoxic chemotherapy or transplant recipient)
Pregnancy
DNR ('do not resuscitate') status
Subject or authorized representative not willing to provide consent (unconscious patient will need to countersign prior to analysis of samples)
Unable to have central venous line or arterial line in place
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Niels D Martin, MD
Phone
215-662-7323
Email
niels.martin@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Joy Steele, RN
Phone
215-662-7323
Email
joy.steele@pennmedicine.upenn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niels D Martin, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Niels D Martin, MD
Phone
215-662-7323
Email
niels.martin@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Joy Steele, RN
Phone
215-662-7323
Email
joy.steele@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Niels D Martin, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
External Drainage of Thoracic Duct Lymph to Reduce Inflammatory Cytokines in Septic Shock Patients
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