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New treatment option for Sepsis
Official title External Drainage of Thoracic Duct Lymph to Reduce Inflammatory Cytokines in Septic Shock Patients
ClinicalTrials.gov ID: NCT04855786
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Adult (18-80 years) patients in Surgical ICU with suspected or documented infection on antibiotics and septic shock defined as hypotension requiring...
- Participants will fulfill the not only at recruitment and consent, but also be confirmed to still meet those criteria immediately prior to transfer...
- 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)...
You likely can't join if
- 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
See the full eligibility 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...
- Participants will fulfill the 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.