Protocol amendments
CKD, chronic kidney injury
Because a patient (12th patient) with chronic kidney injury (CKD) developed a high plasma sodium level (161 mEq/L) and elevated ketone measured by point of care device (subsequently measured by central laboratory and found to be falsely elevated) after the first 50 g of NaAscorbate infusion, we subsequently excluded patients with a creatinine level > 150 µmol/L and/or a Na level > 155 mEq/L before enrolment. In addition, after the 13th patient, we allowed enrolment of patients, who were not for cardiopulmonary resuscitation (CPR) but was for all other treatments (renal replacement therapy, mechanical ventilation and vasopressors). As this study was not designed to assess mortality, but to assess the physiological effects of NaAscorbate and to study feasibility and safety for a future phase II trial, we considered that if the patient was not for CPR but was for all other treatments, enrolment was justified.