No registrations found.
ID
Source
Brief title
Health condition
Septic shock
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in transendothelial electrical resistance (TER) which will be measured using an Electric Cell-substrate Impedance Sensing device(ECIS)
Secondary outcome
- Change in endothelial permeability as assessed by a transwell system
- Markers of endothelial permeability and activation such as (ICAM, VCAM, occludin and PECAM)
- Markers of inflammation (IL-1, TNF, IL-6, IL-8 and vWF antigen level)
Background summary
Rationale:
Sepsis is characterized by the presence of inflammatory-induced endothelial integrity loss. This reduction in endothelial barrier function results in fluid leakage associated with organ failure. Currently, there is no therapy for loss of endothelial barrier function. Evidence is increasing that plasma has protective and restorative effects on endothelial barrier integrity and function in critically ill patients.
Objective:
To investigate whether plasma restores sepsis-induced endothelial barrier integrity in an in vitro model. This will be assessed by incubating human microvascular endothelial cells with plasma samples from septic shock patients.
Study design:
Single center observational study.
Intervention (if applicable):
None
Study population:
Patients with septic shock who are admitted to the ICU
Main study parameters/endpoints:
Changes in transendothelial electrical resistance (TER) and permeability of endothelial cells in vitro.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
The risks are negligible in this study. Blood samples will be obtained from the arterial line at quantities that are not harmful. Standard clinical care will not be altered. Participation in this study does not confer a potential benefit, but future patients with sepsis may benefit from results of this study.
Study objective
Plasma restores sepsis-induced endothelial permeabiliy as measured by transendothelial electrical resistance in an in-vitro ECIS model.
Study design
Patient plasma will be retrieved at 2 time points. The first assesment is within 12 hours after arriving in the ICU.
Intervention
not applicable
Inclusion criteria
- ≥18 years old
- Quick SOFA score ≥2 with suspicion of infection
- MAP < 65 mmHg and lactate > 2 mmol/L despite volume resuscitation, requiring vasopressors
- Arterial catheter placement as part of standard care
- Inclusion within 12 hours after arriving on the ICU
Exclusion criteria
- Absence of informed consent
- Major burns ≥ 18%
- No arterial catheter placement ≤ 12 hours after arriving on the ICU
- Immunosuppressive treatment unrelated to sepsis (recent chemotherapy, chronic use of systemic steroids, methotrexate, tacrolimus, cellcept, ciclosporin, anti-TNF-α antibodies)
- HIV infection
- Pregnancy or breast feeding
- Transfer from another hospital
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8962 |
| CCMO | NL70318.018.19 |
| OMON | NL-OMON49036 |