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

NCT ID: NCT04855786

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2028-07-01

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.

Conditions

Sepsis; Septic Shock

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Thoracic Duct Drainage

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

Group Type: EXPERIMENTAL

Thoracic duct drainage

Intervention Type: PROCEDURE

drain placement into the thoracic duct

Interventions

Thoracic duct drainage

drain placement into the thoracic duct

Intervention Type: PROCEDURE

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).

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

1. Open abdomen

2. Intra-abdominal sepsis preventing access to the lymphatic system

3. Prior instrumentation of the lymphatic system

4. Known occlusion of the left subclavian vein

5. Known malformation of the lymphatic system

6. Previous left axillary node dissection ± left upper limb lymphoedema

7. Class 4 heart failure

8. Any chronic medical condition for which the patient is expected to have <6-month survival

9. Decompensated liver failure with ascites

10. Portal hypertension with history of variceal bleeding

11. Severe allergy to contrast agents

12. Need for continuous anticoagulation (that cannot be stopped for procedure)

13. Uncorrectable coagulopathy or INR >1.5

14. Uncorrectable thrombocytopenia (platelet count less than 50,000)

15. Immunocompromised state (active cytotoxic chemotherapy or transplant recipient)

16. Pregnancy

17. DNR ('do not resuscitate') status

18. Subject or authorized representative not willing to provide consent (unconscious patient will need to countersign prior to analysis of samples)

19. Unable to have central venous line or arterial line in place

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Health Research Council, New Zealand

OTHER

Sponsor Role: collaborator

University of Auckland, New Zealand

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Niels D Martin, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Central Contacts

Niels D Martin, MD

Role: CONTACT

niels.martin@pennmedicine.upenn.edu

215-662-7323

Joy Steele, RN

Role: CONTACT

joy.steele@pennmedicine.upenn.edu

215-662-7323

Other Identifiers

834599

Identifier Type: -

Identifier Source: org_study_id