Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04855786

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thoracic duct drainage

Procedure

drain placement into the thoracic duct

Primary outcomes

  1. Reduction in circulating pro-inflammatory cytokines

    Time frame: over 7 days of drainage

    serial assays of lymph and plasma to measure inflammatory cytokines

Study contacts

Contact information is provided by the study sponsor or research team.

Niels D Martin, MD

CONTACT

[email protected]

215-662-7323

Seema Anandalwar, MD

CONTACT

[email protected]

215-662-7323

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Health Research Council, New Zealand
  • University of Auckland, New Zealand

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 22, 2021
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.