Nathaniel Berman1,2, M Carrington Reid3, Jeanne Teresi4,5, Joseph P Eimicke3,4, Ronald Adelman3. 1. 1 Division of Nephrology and Hypertension, Weill Cornell Medical College , New York, New York. 2. 2 The Rogosin Institute , New York, New York. 3. 3 Division of Geriatrics and Palliative Care, Weill Cornell Medical College , New York, New York. 4. 4 Research Division, Hebrew Home at Riverdale, RiverSpring Health , Bronx, New York. 5. 5 Columbia University Stroud Center at New York State Psychiatric Institute , New York, New York.
Abstract
BACKGROUND: An increasing proportion of hemodialysis patients are ineligible for transplant. Often these patients are elderly, with multiple comorbidities and decreased functional status. Such patients may benefit from modified treatment goals to reduce symptom burden. OBJECTIVE: To demonstrate the feasibility of a trial of reduced-intensity treatment in nontransplantable patients with end-stage renal disease (ESRD). STUDY DESIGN: A 6-week study randomized patients to a reduced-intensity intervention versus usual care. Intervention subjects were treated with liberalized goals for serum phosphorus and parathyroid hormone (PTH) as well as predialysis blood pressure in comparison with usual care subjects. Outcomes included assessed feasibility of recruitment, randomization, and data collection. SETTING AND POPULATION: Sixteen transplant-ineligible hemodialysis patients were recruited from two urban units. MEASUREMENTS: Blood pressure was recorded weekly, while serum PTH and phosphorus were assessed every 10 days. A quality-of-life measure was administered before and after the trial. RESULTS: Of 300 patients, 51 were eligible and 16 consented. All were randomized and completed the trial. Patients in the intervention group received significantly lower doses of phosphorus binders and vitamin D analogues, and were less likely to have their dry weight reduced. All patient surveys were completed. CONCLUSIONS:High-risk hemodialysis patients may benefit from liberalized treatment guidelines but larger studies are necessary.
RCT Entities:
BACKGROUND: An increasing proportion of hemodialysis patients are ineligible for transplant. Often these patients are elderly, with multiple comorbidities and decreased functional status. Such patients may benefit from modified treatment goals to reduce symptom burden. OBJECTIVE: To demonstrate the feasibility of a trial of reduced-intensity treatment in nontransplantable patients with end-stage renal disease (ESRD). STUDY DESIGN: A 6-week study randomized patients to a reduced-intensity intervention versus usual care. Intervention subjects were treated with liberalized goals for serum phosphorus and parathyroid hormone (PTH) as well as predialysis blood pressure in comparison with usual care subjects. Outcomes included assessed feasibility of recruitment, randomization, and data collection. SETTING AND POPULATION: Sixteen transplant-ineligible hemodialysis patients were recruited from two urban units. MEASUREMENTS: Blood pressure was recorded weekly, while serum PTH and phosphorus were assessed every 10 days. A quality-of-life measure was administered before and after the trial. RESULTS: Of 300 patients, 51 were eligible and 16 consented. All were randomized and completed the trial. Patients in the intervention group received significantly lower doses of phosphorus binders and vitamin D analogues, and were less likely to have their dry weight reduced. All patient surveys were completed. CONCLUSIONS: High-risk hemodialysis patients may benefit from liberalized treatment guidelines but larger studies are necessary.
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