Critically ill patients with trauma or sepsis exhibit a high degree of vitamin C deficiency at ICU admission and vitamin C plasma concentrations decrease even more during the first three days of admission.
Conditions
Interventions
Pharmaceutical Form: Solution for injection/infusion
Sponsors
VU university medical center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: >18 years Sepsis or SIRS (systemic inflammatory response syndrome), after major surgery or trauma Non-neurological sequential organ failure score >6 Expected length of ICU stay > 96 hours Informed consent by patient or legal representative 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 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
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 of < 30 ml/min/1.73 m2 (stadium 4-5) Expected need for renal replacement therapy within 48 hours Known glucose 6-phosphate dehydrogenase deficiency History of urolithiasis or oxalate nephropathy Previous use of prolonged high dose vitamin C supplements Hemochromatosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the pharmacokinetics of two high dose regimens of intravenous vitamin C in critically ill patients, in particular the attained plasma concentration and the fraction retained in the body and excreted in urine. ;Secondary Objective: Not applicable;Primary end point(s): Plasma concentrations vitamin C Fraction of vitamin C excreted in urine in relation to the administered dose Clearance (Cl) (ml/min) Volume of distribution (Vd) (L) Elimination half life (t½) (hours) ;Timepoint(s) of evaluation of this end point: 5 days with blood samples at t<0, t=0, 1, 2, 4, 8, 12, 24, 36, 48, 72 and 96 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Reactive oxygen species (ROS) activity in blood (CellROX) Oxidative damage (F2 isoprostanes) Anion gap metabolic acidosis ;Timepoint(s) of evaluation of this end point: 5 days with blood samples at t<0, t=1, 4, 8, 24, 48, 72 and 96 | — |
Countries
Netherlands
Contacts
Public ContactREVIVE
VU university medical center
Outcome results
None listed