Chronic Kidney Disease Clinical Trial
Official title:
Nutritional Therapy to Prevent Progression of Acute Kidney Injury to Chronic Kidney Disease
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.
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.
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