A pilot clinical study of Vitamin C for the prevention of acute kidney injury in critically ill patients

Phase 2

Recruiting

• Conditions: kidney injury; Renal and Urogenital - Kidney disease

• Registration Number: ACTRN12619000909123
• Lead Sponsor: Professor Rinaldo Bellomo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-28
• Last Update Posted: 21 July 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Within first 24 hours of intensive care unit admission
NephroCheck urine test positive result which is defined as a value exceeding more than 2 ng per ml / 1000.
No evidence of acute kidney dysfunction on intensive care unit admission defined as a serum creatinine measured being less than 150 mircomol/L
No chronic kidney disease defined by the stage II or greater using the Kidney Disease Improving Global Outcomes classification
Are expected to stay in the ICU at least until the day after tomorrow.
Use of indwelling urinary catheter as standard care expected for at least 72 hours after enrolment
At least one of the following acute conditions within 24 hours prior to enrolment, which define clinical high-risk of AKI
Respiratory Sequential Organ Failure Assessment (SOFA) score of equal to or greater than 2 (PaO2/FiO2 < 300)
OR
Cardiovascular SOFA score of equal to or greater than 1 (Mean arterial pressure less than 70 mmHg and/or any vasopressor required)

Exclusion Criteria

Pregnancy
DNR (do not resuscitate) DNI (do not intubate) orders
Death is deemed imminent or inevitable during this admission, and either the attending physician, patient or substitute decision-maker is not committed to active treatment
Already receiving dialysis (either acute or chronic) or imminent need of dialysis at the time of enrolment
Known moderate to severe AKI prior to enrolment (KDIGO stage II or greater)
Receiving kidney transplantation
Any other illness that, in the investigator’s judgement, will substantially increase the risk associated with patient's participation in this study
Patients with known HIV infection
Patients with known or suspected history of oxalate nephropathy or hyperoxaluria, scurvy, chronic iron overload, G-6PD deficiency
Clinician expects to prescribe high dose vitamin C for another indications
Patients with known haemochromatosis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified