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We propose to identify malnourished chronic kidney dialysis patients through a statewide effort and subsequently treat them based on a protocol (provision of oral nutritional supplementation) over a period of six (6) months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nepro nutritional supplement | Dietary Supplement | oral nutritional supplement (Nepro); every other day, 3 days per week, for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| increase in serum albumin | 6 months |
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Inclusion Criteria:
On CHD dialysis for more than 6 months
Adequately dialyzed (Kt/V > 1.0) with a biocompatible hemodialysis membrane. Patients with Kt/V > 1.0 but < 1.4 will be evaluated for etiologies of lower than optimal dialysis dose and every effort will be made to increase the Dialysis dose to 1.4 or above. Patients with all access types will be recruited to the study.
Suboptimal nutritional status identified by one of the following criteria:
Protein catabolic rate less than 1.0 g/kg/d calculated by three-point urea kinetic modeling on at least 2 occasions over the past 3 months
Progressive unintentional weight loss more than 2.5% of the initial or ideal body weight and/or patients who are less than 90% of ideal body weight.
Biochemical parameters of malnutrition defined by one of the following measurements over the consecutive two months prior to inclusion:
Subjective Global Assessment Score less than 5.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alp Ikizler, MD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Kidney Foundation | Nashville | Tennessee | 37215 | United States |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| D052776 |
| Female Urogenital Diseases |
| 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 |