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Procedure

Thoracic Duct Drainage for Septic Shock

Q: Does this medical trial have an age restriction, and if so, what is it?

According to the information provided, individuals between 18 and 80 are eligible for this clinical trial with 43 studies open for those under eighteen and 263 slots available for persons over 65.

Q: Is there still availability to join this investigation?

According to clinicaltrials.gov, this trial is presently accepting participants. The investigative project was initially published on January 13th 2022 and updated most recently in December 5th 2022.

Q: How many participants has the research team recruited for their investigation?

Affirmative. Information on clinicaltrials.gov reveals that this study is actively seeking participants, having been initially published on January 13th 2022 and most recently edited in December 5th 2022. Currently 10 individuals need to be recruited at one site.

Q: Do I qualify to participate in this research project?

This investigation requires 10 individuals aged 18-80 with pyemia. They must have undergone surgery in an ICU, be under antibiotic treatment and display hypotension requiring vasopressor therapy to sustain a MAP of over 65mmHg (modified from <a href="https://www.withpower.com/clinical-trials/sepsis">Sepsis</a>-35). In order to qualify, they will need to meet the criteria at recruitment and consent as well as immediately before being transferred for the procedure. If their hemodynamic instability is defined by either a MAP below 65 or active titration/resuscitation that prevents them travelling during the intervention window then they are excluded from study consideration.

N/A

Waitlist Available

Led By Niels D Martin, MD

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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).

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up over 7 days of drainage

Awards & highlights

Study Summary

This trial shows that early thoracic duct cannulation and external lymph drainage may help reduce pro-inflammatory cytokines in adult surgical intensive care patients.

Who is the study for?

This trial is for adults aged 18-80 in the Surgical ICU with suspected or documented infection, on antibiotics, and septic shock needing vasopressors to maintain blood pressure. Excluded are those with severe bleeding risks, compromised immune systems, certain heart/liver conditions, pregnancy, or inability to consent.Check my eligibility

What is being tested?

The study tests if draining lymph from the thoracic duct can lower harmful inflammation markers in septic shock patients. It involves early cannulation of the duct and drainage for up to a week while monitoring safety and other health indicators.See study design

What are the potential side effects?

Potential side effects may include complications from catheter placement such as infection or damage to nearby structures; allergic reactions to contrast agents used during procedures; and issues related to prolonged bed rest.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am an adult in the ICU with an infection and septic shock, needing drugs to keep my blood pressure up.

Select...

I am stable and do not need constant medication adjustments or large fluid boosts.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ over 7 days of drainage

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~over 7 days of drainage

This trial's timeline: 3 weeks for screening, Varies for treatment, and over 7 days of drainage for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Reduction in circulating pro-inflammatory cytokines

Trial Design

1Treatment groups

Experimental Treatment

Group I: Thoracic Duct DrainageExperimental Treatment1 Intervention

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Auckland, New ZealandOTHER

67 Previous Clinical Trials

17,221 Total Patients Enrolled

University of PennsylvaniaLead Sponsor

2,002 Previous Clinical Trials

42,880,989 Total Patients Enrolled

1 Trials studying Septic Shock

52,500 Patients Enrolled for Septic Shock

Health Research Council, New ZealandOTHER

16 Previous Clinical Trials

25,834 Total Patients Enrolled

Media Library

Thoracic duct drainage (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04855786 — N/A

Septic Shock Research Study Groups: Thoracic Duct Drainage

Septic Shock Clinical Trial 2023: Thoracic duct drainage Highlights & Side Effects. Trial Name: NCT04855786 — N/A

Thoracic duct drainage (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04855786 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this medical trial have an age restriction, and if so, what is it?

"According to the information provided, individuals between 18 and 80 are eligible for this clinical trial with 43 studies open for those under eighteen and 263 slots available for persons over 65."

Answered by AI

Is there still availability to join this investigation?

"According to clinicaltrials.gov, this trial is presently accepting participants. The investigative project was initially published on January 13th 2022 and updated most recently in December 5th 2022."

Answered by AI

How many participants has the research team recruited for their investigation?

"Affirmative. Information on clinicaltrials.gov reveals that this study is actively seeking participants, having been initially published on January 13th 2022 and most recently edited in December 5th 2022. Currently 10 individuals need to be recruited at one site."

Answered by AI

Do I qualify to participate in this research project?

"This investigation requires 10 individuals aged 18-80 with pyemia. They must have undergone surgery in an ICU, be under antibiotic treatment and display hypotension requiring vasopressor therapy to sustain a MAP of over 65mmHg (modified from Sepsis-35). In order to qualify, they will need to meet the criteria at recruitment and consent as well as immediately before being transferred for the procedure. If their hemodynamic instability is defined by either a MAP below 65 or active titration/resuscitation that prevents them travelling during the intervention window then they are excluded from study consideration."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "External Drainage of Thoracic Duct Lymph to Reduce Inflammatory Cytokines in Septic Shock Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04855786.

All > Sepsis