Effect of Intravenous Iron Repletion on Renal Function in Patients With Iron Deficiency and Acute Kidney Injury

Acute kidney injury is a complication that occurs in up to 30% of hospitalized patients, iron deficiency has a high incidence in the critically ill patient population and has been associated with multiple complications such as the development of anemia and renal dysfunction. The presence of iron deficiency, anemia and acute kidney damage is a common combination in critically ill patients and it has been seen that iron deficiency promotes mitochondrial dysfunction and this can be improved with the correction of intravenous iron, as has happened in clinical trials of patients with acute heart failure, improving their clinical evolution.

There is insufficient evidence for the implementation of intravenous iron with the aim of improving the parameters of iron deficiency anaemia in patients with acute kidney injury.

To the knowledge of the investigators, there is no clinical trial that has explored this outcomes.

Primary objective:

• Renal function estimated in GFR at 3 months after randomization. Which will be evaluated by the estimation of the GFR by the equation CKD-EPI by serum creatinine

Secondary objectives: all of the following will be at hospital discharge and 28 days after hospital discharge between the intervention group (iron replacement) compared to the control group (placebo).

• ferritin value, (pg/dL)
• transferrin saturation (%)
• Hemoglobin (g/dL)
• serum creatinine (mg/dL)
• initiation of renal support therapy (any type of renal support such as: intermittent haemodialysis, peritoneal dialysis or continuous therapies)
• recovery of renal function, seen as decreased serum creatinine and approaching <0.3mg/dL of baseline creatinine
• death

Exploratory objectives:

• safety of intravenous iron administration compared to placebo: assessed for the occurrence of adverse events such as allergic reaction, hypotension, dyspnea, rash, erythema. These will be evaluated during the administration of the drug and during hospitalization frequently every 24 hours by the nephrology staff that includes the study researchers.

Our hypothesis is that intravenous iron dextran repletion during the treatment of acute kidney injury will improve the parameters of renal function, iron deficiency, anemia and also that it will be safe compared to placebo.

STUDY DESIGN Randomized, placebo-controlled clinical trial, method of randomization in blocks of 5 by frequency of occurrence. In patients with acute renal injury, they will be aleatorized to receive the administration of intravenous iron dextran in 1 single exhibition according to the Mg granted by the Virizzi formula compared to placebo.

The sample size determined 55 patients per group, with a standard deviation of 1.5.

The randomization process was carried out with the NCI Clinical Trial Randomization Tool:

https://ctrandomization.cancer.gov/

Inclusion criteria

• Hospitalized patients with acute kidney injury
• iron levels <13 μmol/L or a transferrin saturation <20%

Exclusion criteria

• AKI within the past three months
• less than 18 years old
• Chronic Kidney Disease grade 5
• chronic dialysis
• kidney transplant
• hospital stay less tahn 48 hours
• received any red blood cell transfusion before randomization
• missing data that would render analysis incomplete.