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| Name | Class |
|---|---|
| Fresenius Kabi | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ad lib diet | No Intervention | Patients who have an episode of Stage 2/3 AKI and are followed in a focused post-AKI clinic. Patients will be asked to continue on their regular diet and the protein and caloric ingestion will be recorded at each visit. | |
| Low Protein Diet + Ketosteril | Experimental | Patients who have an episode of Stage 2/3 AKI and are followed in a focused post-AKI clinic. Patients in this arm will be prescribed a low protein diet (LPD) and +Ketosteril supplementation, 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). Protein and caloric ingestion will be recorded. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low protein diet + ketosteril | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| feasibility of the LPD-K diet | Feasibility: assess the compliance with diet and drug. Compliance to the assigned protein prescription will be estimated at each visit during the intervention period by nutrient intake data obtained from 3-day food records and the estimated protein intake calculated from urinary nitrogen appearance in 24-hour urine samples. Treatment compliance will be assessed by counting returned tablets. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| degree of recovery of renal function | percentage of renal function recovery using baseline estimated GFR as reference. Recovery will be considered as
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Inclusion Criteria:
Exclusion Criteria:
Baseline Chronic Kidney Disease Stage 4 or higher (estimated Glomerular Filtration Rate (eGFR)) <30ml/min/1.73m2) prior to their AKI episode
Patients dialysis dependent at hospital discharge
Dialysis dependency > 14 days at time of enrolment
eGFR exclusion criteria:
Suspected or biopsy proven glomerulonephritis as cause of AKI
Obstructive nephropathy as cause of AKI.
Kidney transplant recipient and patients in the kidney transplant list
Chronic liver disease
High likelihood of re-hospitalization or death in the following 6 months, ascertained by physician in charge of the patient.
Hypercalcemia - Ca > within one standard deviation of reference level upper limit or albumin corrected
Lactating or pregnant woman or woman planning to become pregnant within the timeframe of the study
Inability to follow up study procedures for at least 6 months
Unwillingness to give consent
Institutionalized individuals (prisoners, significant mental illness, or nursing home residents)
Body weight <70% or >150% of standard body weight
History of phenylketonuria or other major disorder of amino acid metabolism
Hypersensitivity to the active substances or to any of the excipients of Ketosteril.
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individual data will not be shared
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D051436 | Renal Insufficiency, Chronic |
| D018450 | Disease Progression |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D018753 | Diet, Protein-Restricted |
| C048995 | ketosteril |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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| 6 months |
| rate of recovery of renal function | Slope of renal function recovery using baseline estimated GFR as reference. | 6 months |
| safety of the LPD-K diet | Evaluate adverse events related to ketosteril by monitoring serum calcium levels at each visit to determine the development of hypercalcemia Serum calcium levels > 10.5 mg/dl | 6 months |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |