Financiado en parte por Danone, Danone Nutricia Research
Randomised controlled trial to determine the efficacy and safety of prescribed water intake to prevent kidney failure due to autosomal dominant polycystic kidney disease (PREVENT-ADPKD)
Wong ATY, Mannix C, Grantham JJ, Allman-Farinelli M, Badve SV, Boudville N, Byth K, Chan J, Coulshed S, Edwards ME, Erickson BJ, Fernando M, Foster S, Haloob I, Harris DCH, Hawley CM, Hill J, Howard K, Howell M, Jiang SH, Johnson DW, Kline TL, Kumar K, Lee VW, Lee VW, Lonergan M, Mai J, McCloud P, Peduto A, Rangan A, Roger SD, Sud K, Torres V, Vilayur E, Rangan GK
BMJ open · 55 citas
Etiquetas de revisión
Vínculos de autores con la industriaFinanciado por la industriaDatos neutrales que nuestra revisión registró sobre cómo se hizo este estudio. Describen el método, nunca si nos gusta el resultado.
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiado por la industria
- Empresa
- Danone
- Universidad u hospital
- London Health Sciences Centre
- Universidad u hospital
- Western Sydney Local Health District
- Empresa
- Danone Nutricia Research
- Gobierno
- National Health and Medical Research Council
- Universidad u hospital
- Sydney Medical School
- Gobierno
- National Institute of Diabetes and Digestive and Kidney Diseases
- Gobierno
- NIDDK NIH HHS
- Organización sin fines de lucro
- Westmead Medical Research Foundation
- Universidad u hospital
- Westmead Institute for Medical Research
- Autores
- Al menos un autor declara un vínculo económico con la industria
- Subvenciones
- National Institute of Diabetes and Digestive and Kidney Diseases (P30-DK090728)
Según 10 financiadores declarados y la declaración de financiación del texto completo.
Publicación
- Publicado
- 2018-01-01 · BMJ Open · vol. 8 · número 1 · pág. e018794
- Editorial
- BMJ
- Citado
- 87 citas · más que el 98% de estudios similares · 8.3× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 52 trabajos
- Acceso
- Acceso abierto (revista) · CC-BY
- Áreas de investigación
- Genetic and Kidney Cyst Diseases · Dialysis and Renal Disease Management · Electrolyte and hormonal disorders
- Palabras clave
- Medicine, Autosomal dominant polycystic kidney disease, Renal function, Kidney disease, Urine osmolality, Tolvaptan, Internal medicine, Polycystic kidney disease, Urine specific gravity, Clinical endpoint, Randomized controlled trial, Vasopressin, Kidney, Urology, Urine
- MeSH
- kidney, humans, polycystic kidney, autosomal dominant, kidney failure, chronic, disease progression, magnetic resonance imaging, glomerular filtration rate, fluid therapy, prospective studies, blood pressure, drinking, osmolar concentration, text messaging
34 autores
- Annette T. Y. Wong🇦🇺The University of Sydney; Westmead Hospital; Sydney Local Health District; Westmead Institute for Medical Research; Western Sydney Local Health District
- Carly Mannix🇦🇺The University of Sydney; Westmead Hospital; Sydney Local Health District; Westmead Institute for Medical Research; Western Sydney Local Health District
- Jared J. Grantham🇺🇸University Medical Center; University of Kansas Medical Center
- Margaret A Allman-Farinelli🇦🇺The University of Sydney
- Sunil V. Badve🇦🇺St George Hospital
- Neil C Boudville🇦🇺The University of Western Australia; Harry Perkins Institute of Medical Research; Sir Charles Gairdner Hospital
- Karen Byth🇦🇺Westmead Hospital; Sydney Local Health District; Western Sydney Local Health District
- Jessie S. M. Chan
- Susan Coulshed
- Marie E. Edwards🇺🇸Mayo Clinic
- Bradley James Erickson🇺🇸Mayo Clinic
- Mangalee R. Fernando🇦🇺UNSW Sydney; Prince of Wales Hospital; South Eastern Sydney Local Health District
- Sheryl Foster🇦🇺The University of Sydney; Westmead Hospital; Sydney Local Health District
- Imad Adbi Haloob
- David C.H. Harris🇦🇺The University of Sydney; Westmead Hospital; Sydney Local Health District; Westmead Institute for Medical Research; Western Sydney Local Health District
- Carmel Mary Hawley🇦🇺Princess Alexandra Hospital
- Julie Hill
- Kirsten Howard🇦🇺The University of Sydney
- Martin Howell🇦🇺The University of Sydney
- Simon Jiang🇦🇺Australian National University; Canberra Hospital
- David Wayne Johnson🇦🇺Princess Alexandra Hospital
- Timothy L. Kline🇺🇸Mayo Clinic
- Karthik Kumar🇦🇺Gosford Hospital
- Vincent W. Lee🇦🇺The University of Sydney; Westmead Hospital; Sydney Children's Hospital; Sydney Local Health District; Westmead Institute for Medical Research; Western Sydney Local Health District
- Maureen Lonergan🇦🇺Wollongong Hospital; Illawarra Shoalhaven Local Health District
- Jun Mai🇦🇺Liverpool Hospital; Sydney Local Health District
- Philip McCloud
- Anthony J. Peduto🇦🇺Westmead Hospital; Sydney Local Health District
- Anna Rangan🇦🇺The University of Sydney
- Simon D. Roger🇦🇺Gosford Hospital
- Kamal Sud🇦🇺The University of Sydney; Nepean Hospital; Westmead Hospital; Sydney Local Health District; Western Sydney Local Health District
- Vicente E. Torres🇺🇸Mayo Clinic
- Eswari Vliayuri🇦🇺John Hunter Hospital
- Gopala K. Rangan🇦🇺 · autor de correspondenciaThe University of Sydney; Westmead Hospital; Sydney Local Health District; Westmead Institute for Medical Research; Western Sydney Local Health District
Resumen
El texto original del estudio, en el idioma en que se publicó.
Introduction
Maintaining fluid intake sufficient to reduce arginine vasopressin (AVP) secretion has been hypothesised to slow kidney cyst growth in autosomal dominant polycystic kidney disease (ADPKD). However, evidence to support this as a clinical practice recommendation is of poor quality. The aim of the present study is to determine the long-term efficacy and safety of prescribed water intake to prevent the progression of height-adjusted total kidney volume (ht-TKV) in patients with chronic kidney disease (stages 1-3) due to ADPKD.
Methods and analysis
A multicentre, prospective, parallel-group, open-label, randomised controlled trial will be conducted. Patients with ADPKD (n=180; age ≤65 years, estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2) will be randomised (1:1) to either the control (standard treatment+usual fluid intake) or intervention (standard treatment+prescribed fluid intake) group. Participants in the intervention arm will be prescribed an individualised daily fluid intake to reduce urine osmolality to ≤270 mOsmol/kg, and supported with structured clinic and telephonic dietetic review, self-monitoring of urine-specific gravity, short message service text reminders and internet-based tools. All participants will have 6-monthly follow-up visits, and ht-TKV will be measured by MRI at 0, 18 and 36 months. The primary end point is the annual rate of change in ht-TKV as determined by serial renal MRI in control vs intervention groups, from baseline to 3 years. The secondary end points are differences between the two groups in systemic AVP activity, renal disease (eGFR, blood pressure, renal pain), patient adherence, acceptability and safety.
Ethics and dissemination
The trial was approved by the Human Research Ethics Committee, Western Sydney Local Health District. The results will inform clinicians, patients and policy-makers regarding the long-term safety, efficacy and feasibility of prescribed fluid intake as an approach to reduce kidney cyst growth in patients with ADPKD.
Trial registration number
ANZCTR12614001216606.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY).
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