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Efficacy and safety of a very-low-protein diet when postponing dialysis in the elderly: a prospective randomized multicenter controlled study.
Am J Kidney Dis. 2007 May; 49(5):569-80.AJ

Abstract

BACKGROUND

A supplemented very-low-protein diet (sVLPD) seems to be safe when postponing dialysis therapy.

STUDY DESIGN

Prospective multicenter randomized controlled study designed to assess the noninferiority of diet versus dialysis in 1-year mortality assessed by using intention-to-treat and per-protocol analysis.

SETTING & PARTICIPANTS

Italian uremic patients without diabetes older than 70 years with glomerular filtration rate of 5 to 7 mL/min (0.08 to 0.12 mL/s).

INTERVENTION

Randomization to an sVLPD (diet group) or dialysis. The sVLPD is a vegan diet (35 kcal; proteins, 0.3 g/kg body weight daily) supplemented with keto-analogues, amino acids, and vitamins. Patients following an sVLPD started dialysis therapy in the case of malnutrition, intractable fluid overload, hyperkalemia, or appearance of uremic symptoms.

OUTCOMES & MEASUREMENTS

Mortality, hospitalization, and metabolic markers.

RESULTS

56 patients were randomly assigned to each group, median follow-up was 26.5 months (interquartile range, 40), and patients in the diet group spent a median of 10.7 months (interquartile range, 11) following an sVLPD. Forty patients in the diet group started dialysis treatment because of either fluid overload or hyperkalemia. There were 31 deaths (55%) in the dialysis group and 28 deaths (50%) in the diet group. One-year observed survival rates at intention to treat were 83.7% (95% confidence interval [CI], 74.5 to 94.0) in the dialysis group versus 87.3% (95% CI, 78.9 to 96.5) in the diet group (log-rank test for noninferiority, P < 0.001; for superiority, P = 0.6): the difference in survival was -3.6% (95% CI, -17 to +10; P = 0.002). The hazard ratio for hospitalization was 1.50 for the dialysis group (95% CI, 1.11 to 2.01; P < 0.01).

LIMITATIONS

The unblinded nature of the study, exclusion of patients with diabetes, and incomplete enrollment.

CONCLUSION

An sVLPD was effective and safe when postponing dialysis treatment in elderly patients without diabetes.

Links

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Authors+Show Affiliations

Brunori G
Division of Nephrology, Spedali Civili Brescia, Italy. gcbrunori@hotmail.com <gcbrunori@hotmail.com>
Viola BF
No affiliation info available
Parrinello G
No affiliation info available
De Biase V
No affiliation info available
Como G
No affiliation info available
Franco V
No affiliation info available
Garibotto G
No affiliation info available
Zubani R
No affiliation info available
Cancarini GC
No affiliation info available

MeSH

AgedAged, 80 and overDiet, Protein-RestrictedFemaleFollow-Up StudiesHumansKidney Failure, ChronicMaleProspective StudiesRenal DialysisSurvival RateTime Factors

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

17472838

Clinical Trial Links

Clinical trial which this article describes
Renal Effects of Meditarranean Diet and Low-protein Diet With Ketoacids on Physiological Intestinal Mibrobiota in CKD

Citation

Brunori, Giuliano, et al. "Efficacy and Safety of a Very-low-protein Diet when Postponing Dialysis in the Elderly: a Prospective Randomized Multicenter Controlled Study." American Journal of Kidney Diseases : the Official Journal of the National Kidney Foundation, vol. 49, no. 5, 2007, pp. 569-80.
Brunori G, Viola BF, Parrinello G, et al. Efficacy and safety of a very-low-protein diet when postponing dialysis in the elderly: a prospective randomized multicenter controlled study. Am J Kidney Dis. 2007;49(5):569-80.
Brunori, G., Viola, B. F., Parrinello, G., De Biase, V., Como, G., Franco, V., Garibotto, G., Zubani, R., & Cancarini, G. C. (2007). Efficacy and safety of a very-low-protein diet when postponing dialysis in the elderly: a prospective randomized multicenter controlled study. American Journal of Kidney Diseases : the Official Journal of the National Kidney Foundation, 49(5), 569-80.
Brunori G, et al. Efficacy and Safety of a Very-low-protein Diet when Postponing Dialysis in the Elderly: a Prospective Randomized Multicenter Controlled Study. Am J Kidney Dis. 2007;49(5):569-80. PubMed PMID: 17472838.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of a very-low-protein diet when postponing dialysis in the elderly: a prospective randomized multicenter controlled study. AU - Brunori,Giuliano, AU - Viola,Battista F, AU - Parrinello,Giovanni, AU - De Biase,Vincenzo, AU - Como,Giovanna, AU - Franco,Vincenzo, AU - Garibotto,Giacomo, AU - Zubani,Roberto, AU - Cancarini,Giovanni C, PY - 2006/10/02/received PY - 2007/02/27/accepted PY - 2007/5/3/pubmed PY - 2007/5/29/medline PY - 2007/5/3/entrez SP - 569 EP - 80 JF - American journal of kidney diseases : the official journal of the National Kidney Foundation JO - Am J Kidney Dis VL - 49 IS - 5 N2 - BACKGROUND: A supplemented very-low-protein diet (sVLPD) seems to be safe when postponing dialysis therapy. STUDY DESIGN: Prospective multicenter randomized controlled study designed to assess the noninferiority of diet versus dialysis in 1-year mortality assessed by using intention-to-treat and per-protocol analysis. SETTING & PARTICIPANTS: Italian uremic patients without diabetes older than 70 years with glomerular filtration rate of 5 to 7 mL/min (0.08 to 0.12 mL/s). INTERVENTION: Randomization to an sVLPD (diet group) or dialysis. The sVLPD is a vegan diet (35 kcal; proteins, 0.3 g/kg body weight daily) supplemented with keto-analogues, amino acids, and vitamins. Patients following an sVLPD started dialysis therapy in the case of malnutrition, intractable fluid overload, hyperkalemia, or appearance of uremic symptoms. OUTCOMES & MEASUREMENTS: Mortality, hospitalization, and metabolic markers. RESULTS: 56 patients were randomly assigned to each group, median follow-up was 26.5 months (interquartile range, 40), and patients in the diet group spent a median of 10.7 months (interquartile range, 11) following an sVLPD. Forty patients in the diet group started dialysis treatment because of either fluid overload or hyperkalemia. There were 31 deaths (55%) in the dialysis group and 28 deaths (50%) in the diet group. One-year observed survival rates at intention to treat were 83.7% (95% confidence interval [CI], 74.5 to 94.0) in the dialysis group versus 87.3% (95% CI, 78.9 to 96.5) in the diet group (log-rank test for noninferiority, P < 0.001; for superiority, P = 0.6): the difference in survival was -3.6% (95% CI, -17 to +10; P = 0.002). The hazard ratio for hospitalization was 1.50 for the dialysis group (95% CI, 1.11 to 2.01; P < 0.01). LIMITATIONS: The unblinded nature of the study, exclusion of patients with diabetes, and incomplete enrollment. CONCLUSION: An sVLPD was effective and safe when postponing dialysis treatment in elderly patients without diabetes. SN - 1523-6838 UR - https://www.unboundmedicine.com/medline/citation/17472838/Efficacy_and_safety_of_a_very_low_protein_diet_when_postponing_dialysis_in_the_elderly:_a_prospective_randomized_multicenter_controlled_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0272-6386(07)00557-4 DB - PRIME DP - Unbound Medicine ER -