Hemodialysis Nutritional Risk Stratification Clinical Trial
This prospective observational study is planned to validate OSND against the prospective morbidity and mortality in chronic hemodialysis patients and to examine the hypothesis that OSND risk stratification of chronic HD patients is useful in predicting outcomes and better than its component alone or in diverse combinations. The investigators specific aim is to validate OSND in chronic HD patients by comparing it with conventional measures of nutritional state, including blood tests, anthropometry, MIS, GNRI, bioelectric impedance analysis and several measures of clinical outcome including prospective mortality and hospitalization.
| Status | Recruiting |
| Enrollment | 300 |
| Est. completion date | December 2013 |
| Est. primary completion date | October 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: 1. Male or female, age > 18 years, in chronic hemodialysis treatment at least 3 months 2. Stable and adequate hemodialysis treatment three months prior to participation in study as defined by Kt/V > 1.2 and/or hemodialysis performed 4 hours 3 times weekly 3. Patients with normal hydration status (edema-free), with no neuroid-muscular diseases 4. Informed consent obtained before any trial-related activities Exclusion Criteria: 1. Patients with edema, pleural effusion or ascites at their initial assessment 2. Patients with active malignant disease or liver cirrhosis 3. Patients with neuroid-muscular diseases 4. Patients on chronic treatment with steroids on doses > 10 mg/day Prednisone (or equivalent) 5. Patients treated with immunosuppressive agents 6. Patients suffering from - Acute vasculitis - Severe systemic infections - Heart failure (NYHA class III-IV) |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Israel | Assaf Harofeh Medical Center | Zerifin |
| Lead Sponsor | Collaborator |
|---|---|
| Assaf-Harofeh Medical Center |
Israel,
Beberashvili I, Azar A, Sinuani I, Yasur H, Feldman L, Averbukh Z, Weissgarten J. Objective Score of Nutrition on Dialysis (OSND) as an alternative for the malnutrition-inflammation score in assessment of nutritional risk of haemodialysis patients. Nephrol Dial Transplant. 2010 Aug;25(8):2662-71. doi: 10.1093/ndt/gfq031. Epub 2010 Feb 26. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | All cause morbidity and mortality | Associations of OSND with: Morbidity: Days at hospital (over night stay). Measured from baseline to end of study Morbidity: Number of sick days during the study period Morbidity: Number of visits to health care professionals other than hospitals Mortality: From baseline visit to end of study Interobserver reproducibility of OSND. |
during 2 years of observation | No |
| Secondary | All cause morbidity and mortality | Associations of MIS, GNRI and phase angle with: Morbidity: Days at hospital (over night stay). Measured from baseline to end of study Morbidity: Number of sick days during the study period Morbidity: Number of visits to health care professionals other than hospitals Mortality: From baseline visit to end of study |
2 years | No |