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

Sponsor

University of Pennsylvania (Other)

Overall Status

Recruiting

CT.gov ID

NCT04855786

Collaborator

Health Research Council, New Zealand (Other), University of Auckland, New Zealand (Other)

Enrollment

Location

Arm

9.6

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sepsis Septic Shock	Procedure: Thoracic duct drainage	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 13, 2022

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Thoracic Duct Drainage This is the main study group of patients with thoracic duct drainage	Procedure: Thoracic duct drainage drain placement into the thoracic duct

Arm

Intervention/Treatment

Experimental: Thoracic Duct Drainage

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

Procedure: Thoracic duct drainage

drain placement into the thoracic duct

Outcome Measures

Primary Outcome Measures

Reduction in circulating pro-inflammatory cytokines [over 7 days of drainage]
serial assays of lymph and plasma to measure inflammatory cytokines

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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