Nutritional Therapy to Prevent Progression of Acute Kidney Injury to Chronic Kidney Disease
Condition: Acute Kidney Injury; Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Acute Kidney Injury; Disease Progression; Wounds and Injuries
Study type: Interventional

Summary: 
      This study will evaluate patients who have an episode of moderate to severe acute kidney
      injury (AKI) and are followed in a focused post-AKI clinic. After patients present signs of
      kidney recovery and before hospital discharge, patients who give consent will be enrolled in
      the study. At the first post-AKI clinic visit, patients will be randomly allocated to follow
      a normal (ad-lib) or a low protein diet (LPD) for 3 months. Patients allocated to a LPD will
      receive a drug called Ketosteril. This drug allows the intake of essential amino acids while
      minimizing the amino-nitrogen intake, what in excess, can be bad for the recovered kidney.
      The investigators will evaluate the nutritional parameters and the kidney recovery of all
      patients and compare these parameters in those two groups.
    

Detailed description: 
      This is a pilot single center, randomized controlled, trial of patients who have an episode
      of Stage 2/3 AKI and are followed in a focused post-AKI clinic. Patients will be randomize to
      either; a. LPD-K diet containing 0.6 g protein/kg per day, phosphorus 5-10 mg/kg/day,
      Ketosteril 1 capsule per 5 kg body weight/day divided over three doses (max 8 capsules per
      dose) or b. ad lib diet. Ketosteril should be takes daily during meals and the tablets must
      not be chewed. Ingestion during meals facilitates proper absorption and the metabolisation
      into the corresponding amino acids.

      After the initial assessment, those randomized to LPD-K will be on this diet for a maximum of
      90 days. Additional interventions will include dietary counselling and questionnaire in both
      groups. We would aim for maintaining serum bicarbonate levels ≥ 22meq/L in both groups.

      Evaluation of renal function will be performed using blood and urine tests. In addition,
      specimens will be collected in a bio-repository, and tested for biomarkers of renal
      structural damage. Comprehensive nutritional assessment will be performed by a dietitian,
      along with bioelectrical impedance measurements, blood and urine tests. 24-hour urine urea
      nitrogen and food records will be used to estimate the protein intake of each individual.
      Quality of well-being will be assessed using a standardized tool such as Euro Quality of Life
      (EQ-5D), Charlson Index, and Short Form 8 (SF8) or equivalent. Relevant clinical events
      (adherence to follow-up, death, hospitalization, renal recovery, repeat AKI episodes) will be
      tracked throughout the study.
    

Intervention name(s): low protein diet + ketosteril
Intervention type(s): Other
Intervention description(s): Patients will follow a diet containing 0.6 g protein/kg per day, phosphorus 5-10 mg/kg/day, Ketosteril 1 capsule per 5 kg body weight/day divided over three doses (max 8 capsules per dose).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: nutrition; progression