sepsis of SIRS (systemische inflammatie) met orgaanfalen sepsis trauma
Conditions
Interventions
Patients will receive a daily dose of either 2 or 10 gram vitamin C by
intermittent dosing (half of the daily dose b.i.d.) or by continuous infusion
for two days.
Antioxidants
Critically ill
Pharmacokinetics
Vitamin C
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: >18 years Sepsis or SIRS (systemic inflammatory response syndrome), after major surgery or trauma Non-neurological sequential organ failure score (SOFA) >6 Expected length of ICU stay >96 hours Informed consent initially the legal representative and later by the patient
Exclusion criteria
Exclusion criteria: Admission after out of hospital cardiac arrest Prior use of supplemental vitamin C in the week before Major bleeding Pre-existent renal insufficiency defined as an eGFR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints are plasma concentrations and pharmacokinetic parameters clearance (Cl), volume of distribution (Vd) and elilmination half life (T* ), the fraction of retained vitamin C in the body and the fraction/amount of vitamin C excreted in urine. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are effect and safety parameters: oxidative damage (F2 isoprostanes), leukocyte reactive oxygen species (ROS) activity in blood and the development of high anion-gap acidosis. Explorative endpoints are clinical and biochemical markers of circulation, organ function and injury: sublingual microcirculation, renal resistive index, changes in noradrenalin dose, serum creatinine and SOFA score, and the bioimpedance markers resistance, reactance and phase angle. | — |
Countries
The Netherlands
Outcome results
None listed