Acute critical illnes requiring volume resuscitation with fluids (e.g. Sepsis).
Conditions
Interventions
Trade Name: Omniplasma
Pharmaceutical Form: Solution for infusion
Trade Name: Allbuman 40 g/l
Product Name: Albumin
Pharmaceutical Form: Solution for infusion
Trade Name: Plasma-Lyte 148
Pharmaceuti
Sponsors
AMC
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Healthy male volunteer - Between 18-35 years old - BMI between 20-25 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 24 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - No informed consent - Any abnormal lab or urine test result during the screening prior to inclusion of the study - Use of medication on prescription - Blood donation 38.5) - Known allergic reaction to albumin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the proposed study is to investigate the effect of plasma products and albumin on markers of endothelial function in a human endotoxemia model.;Secondary Objective: To demonstrate that the use of higher albumin content is associated with less endothelial dysfunction and improved tissue oxygenation compared to the use of crystalloids (standard care) in human endotoxemia - To demonstrate that the use of plasma is associated with less endothelial dysfunction and improved tissue oxygenation compared to the use of albumin in human endotoxemia - To investigate specific mechanisms of action of plasma on endothelial parameters - To demonstrate that plasma as a fluid therapy is safe, and does not aggravate an inflammatory or pro-coagulant host response in human endotoxemia.;Primary end point(s): Syndecan-1: a marker of endothelial injury and shedding of the glycocalyx;Timepoint(s) of evaluation of this end point: 1. Before administration of LPS 2. Before administration of infusion fluid 3. 2 hours after infusion 4. 4 hours after infusion 5. 6 hours after infusion | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Levels of endothelial permeability, such as sTM, vWF, A13 antigen and activity. - Blood count and coagulation tests (Hb, WBC, platelet count, PT, fibrinogen, Ddimer, AT) - Markers of tissue oxygenation such as lactate, NIRS, mitoPo2 - Markers of tissue perfusion such as SDF, cardiac output - Physiologic measurements (MAP, heart rate, temperature) - Arterial pulse wave morphology and non invasive cardiac output;Timepoint(s) of evaluation of this end point: - Levels of endothelial permeability, such as sTM, vWF, A13 antigen and activity --> at 2, 4 and 6 hours after infusion - Blood count and coagulation tests (Hb, WBC, platelet count, PT, fibrinogen, Ddimer, AT) --> at 2, 4 and 6 hours after infusion - Markers of tissue oxygenation such as lactate, NIRS, mitoPo2 --> every hour - Markers of tissue perfusion such as SDF, cardiac output --> 30 minute intervals - Physiologic measurements (MAP, heart rate, temperature) --> 30 minute intervals - Arterial pulse wave morphology and non invasive cardiac output --> every hour | — |
Countries
Netherlands
Contacts
Public ContactNicole Juffermans
AMC
Outcome results
None listed