Pharmacokinetics of Two Different High-dose Regimens of Intravenous Vitamin C in Critically Ill Patients

• Status: Completed
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the pharmacokinetic properties of two different dosage regimens of intravenous vitamin C in patients admitted to the Intensive Care Unit with life-threatening illness.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VU University Medical Center
• Treatments: Ascorbic Acid; Vitamins

Criteria

Inclusion Criteria:

• Sepsis or Systemic Inflammatory Response Syndrome (SIRS) after major surgery or trauma;

• Non-neurological sequential organ failure assessment (SOFA) score >6;

• Expected length of ICU stay > 96 hours;

• Written proxy consent by legal representative.

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