None listed
Conditions
Brief summary
Acute kidney injury (AKI) is a medical term that defines a condition when kidneys fail to make enough urine output or dispose of waste products leading to increased level of toxins in blood. AKI effects close to one-third of patients admitted to the intensive care unit (ICU). AKI is problematic as it makes patient care more difficult and exposes such patients to extra risks. This is because patients cannot remove drugs and toxins effectively and cannot control fluids, potassium, and blood acidity in a normal way. AKI, therefore, increases risk of death, and prolongs ICU and hospital length of stay. Unfortunately, despite numerous efforts, no effective treatment to prevent AKI has been developed. One of the reasons for this is that it is difficult to find out which patients are going to develop AKI early enough to intervene. However, there has been recent progressed in this area. A new urine test has been developed called NephroCheck, which measures proteins in the urine that are released when the kidneys are under stress. If such protein levels are high, then these patients are very likely to develop AKI in the next 24 hours. This means that early treatments to can be applied. Recently, there has been much research regarding the possibility that, in ICU patients, high dose vitamin C, given into through a vein, can protect organs (including the kidney) from malfunctioning in the setting of stress, as occurs in critically ill ICU patients. Such treatment is very safe and has not been reported to cause any side effects so far. It is unknown whether intervening early, in response to the findings of positive NephroCheck test, can prevent the development of AKI. However, the consensus view of the Austin hospital ICU treating team is that, in light of the available evidence, the introduction of such vitamin C therapy is both safe and desirable in ICU and should be studied. In response, we plan to perform a study to test whether giving high dose vitamin C to patients who have a high risk of developing AKI as identified by positive NephroCheck test can decrease the occurrence and/or intensity of AKI.
Interventions
Loading of intravenous Vitamin C 30 mg (diluted in 5% DW 250 ml) infused at 15 gm (125 ml) over 1 hour followed by intravenous Vitamin C 15 gm (125 ml) infused over 5 hours).
Followed by intravenous Vitamin C 1500 mg (diluted in 5% DW 100ml) infused over 1 hour administered every 6 hours.
The study treatment will be given every six hours until:
- For a maximum of 72 hours (3 days) OR
- Receiving renal replacement therapy OR
- The patient is discharged from ICU OR
- Patient dies
- The patient dev
Loading of intravenous Vitamin C 30 mg (diluted in 5% DW 250 ml) infused at 15 gm (125 ml) over 1 hour followed by intravenous Vitamin C 15 gm (125 ml) infused over 5 hours). Followed by intravenous Vitamin C 1500 mg (diluted in 5% DW 100ml) infused over 1 hour administered every 6 hours. The study treatment will be given every six hours until: - For a maximum of 72 hours (3 days) OR - Receiving renal replacement therapy OR - The patient is discharged from ICU OR - Patient dies - The patient develops a complication which may be related to the study drug (whichever occurs first)
Sponsors
Professor Rinaldo Bellomo
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed