Pharmacokinetics of two high dose regimes of intravenous vitamin C in critically ill patients

Phase 2

Completed

Conditions: sepsis of SIRS (systemische inflammatie) met orgaanfalen
sepsis
trauma

Registration Number: NL-OMON42302

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

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

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 < 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoints are plasma concentrations and pharmacokinetic parameters<br /><br>clearance (Cl), volume of distribution (Vd) and elilmination half life (T* ),<br /><br>the fraction of retained vitamin C in the body and the fraction/amount of<br /><br>vitamin C excreted in urine. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are effect and safety parameters: oxidative damage (F2<br /><br>isoprostanes), leukocyte reactive oxygen species (ROS) activity in blood and<br /><br>the development of high anion-gap acidosis. Explorative endpoints are clinical<br /><br>and biochemical markers of circulation, organ function and injury: sublingual<br /><br>microcirculation, renal resistive index, changes in noradrenalin dose, serum<br /><br>creatinine and SOFA score, and the bioimpedance markers resistance, reactance<br /><br>and phase angle. </p><br>