Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Location status: Recruiting
Location contact
Niels D Martin, MD
CONTACT
Niels Martin, MD
PRINCIPAL_INVESTIGATOR
Seema Anandalwar, MD
CONTACT
NCT Number: NCT04855786
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Philadelphia, Pennsylvania, 19104, United States
Location status: Recruiting
Niels D Martin, MD
CONTACT
Niels Martin, MD
PRINCIPAL_INVESTIGATOR
Seema Anandalwar, MD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
drain placement into the thoracic duct
Time frame: over 7 days of drainage
serial assays of lymph and plasma to measure inflammatory cytokines
Contact information is provided by the study sponsor or research team.
Niels D Martin, MD
CONTACT
Seema Anandalwar, MD
CONTACT
University of Pennsylvania
Other
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
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.
NCT07388628
Immunoparalysis in Septic Shock, Infections
Magdeburg, Germany
View Trial DetailsNCT03334006
Digestive System Diseases, Infections
Vienna, Austria
View Trial DetailsNCT07451886
Infections, Inflammation
Hong Kong
View Trial DetailsNCT07582926
Infections, Inflammation
Ankara, Turkey (Türkiye)
View Trial Details