High water vs. ad libitum water intake for autosomal dominant polycystic kidney disease: a randomized controlled feasibility trial
El-Damanawi R, Lee M, Harris T, Cowley LB, Bond S, Pavey H, Sandford RN, Wilkinson IB, Karet Frankl FE, Hiemstra TF
QJM : monthly journal of the Association of Physicians · 20 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
- Gobierno
- National Institute on Handicapped Research
- Organización sin fines de lucro
- Polycystic Kidney Disease Charity
- Universidad u hospital
- NIHR Biomedical Research Centre, Royal Marsden NHS Foundation Trust/Institute of Cancer Research
- Gobierno
- National Institute for Health and Care Research
- Gobierno
- Department of Health and Social Care
- Organización sin fines de lucro
- Kidney Research UK
- Organización sin fines de lucro
- British Renal Society
- Universidad u hospital
- Cambridge University Hospitals
- Gobierno
- NIHR Cambridge Biomedical Research Centre
- Organización sin fines de lucro
- British Renal Society and Kidney Care UK Joint Grants Programme
- Gobierno
- BRC
- Gobierno
- National Institute for Health Research (NIHR)
- Organización sin fines de lucro
- PKD Charity
- Universidad u hospital
- Cambridge Biomedical Research Centre
- Organización sin fines de lucro
- Addenbrooke’s Charitable Trust
- Subvenciones
- Kidney Research UK (TF-009-20161125); National Institute for Health and Care Research (NF-SI-0515-10093)
Según 15 financiadores declarados.
Publicación
- Publicado
- 2019-10-25 · QJM · vol. 113 · número 4 · págs. 258–265
- Editorial
- Oxford University Press
- Citado
- 26 citas · más que el 87% de estudios similares · 2.0× el promedio de su campo
- Referencias
- 39 trabajos
- Acceso
- Acceso abierto (revista híbrida) · CC-BY-NC
- Áreas de investigación
- Genetic and Kidney Cyst Diseases · Tuberous Sclerosis Complex Research · Cystic Fibrosis Research Advances
- Palabras clave
- autosomal dominant polycystic kidney disease, vasopressin, urine osmolality, urine specific gravity, self-management, adherence, hyponatremia, cyst growth, feasibility, home monitoring, acute kidney injury, EGFR, urine output
- MeSH
- humans, polycystic kidney, autosomal dominant, water, vasopressins, glomerular filtration rate, treatment outcome, prospective studies, feasibility studies, drinking, adult, middle aged, female, male, young adult
10 autores
- Ragada El-Damanawi🇬🇧University of Cambridge; Cambridge University Hospitals NHS Foundation Trust; Cambridge Clinical Trials Unit
- M Lee🇬🇧University of Cambridge
- Tess Harris🇬🇧Polycystic Kidney Disease Charity
- Laura B Cowley🇬🇧Cambridge University Hospitals NHS Foundation Trust; National Institute for Health and Care Research; NIHR Cambridge Biomedical Research Centre; Cambridge Clinical Trials Unit
- Simon J. Bond🇬🇧Cambridge University Hospitals NHS Foundation Trust; Cambridge Clinical Trials Unit
- Holly Pavey🇬🇧Cambridge University Hospitals NHS Foundation Trust; Cambridge Clinical Trials Unit
- Richard N. Sandford🇬🇧University of Cambridge
- Ian B. Wilkinson🇬🇧University of Cambridge; Cambridge University Hospitals NHS Foundation Trust; Cambridge Clinical Trials Unit
- Fiona E. Karet🇬🇧University of Cambridge
- Thomas F. Hiemstra🇬🇧 · autor de correspondenciaUniversity of Cambridge; Cambridge University Hospitals NHS Foundation Trust; Cambridge Clinical Trials Unit
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
Vasopressin stimulates cyst growth in autosomal dominant polycystic kidney disease (ADPKD) and is a key therapeutic target. Evaluation of high water intake as an alternative to pharmacological vasopressin blockade is supported by patients. However feasibility, safety and adherence-promoting strategies required to deliver this remain unknown.
Aims
Assess the feasibility of a definitive randomized high water intake trial in ADPKD.
Methods
In this prospective open-label randomized trial, adult ADPKD patients with eGFR ≥ 20 ml/min/1.73 m2 were randomized to prescribed high water (HW) intake targeting urine osmolality (UOsm) ≤270 mOsm/kg, or ad libitum (AW) intake (UOsm >300 mOsm/kg). Self-management strategies including home-monitoring of urine-specific gravity (USG) were employed to promote adherence.
Results
We enrolled 42 participants, baseline median eGFR (HW 68.4 [interquartile range (IQR) 35.9-107.2] vs. AW 75.8 [IQR 59.0-111.0 ml/min/1.73 m2, P = 0.22) and UOsm (HW 353 [IQR 190-438] vs. AW 350 [IQR 240-452] mOsm/kg, P = 0.71) were similar between groups. After 8 weeks, 67% in the HW vs. 24% in AW group achieved UOsm ≤270 mOsm/kg, P = 0.001. HW group achieved lower UOsm (194 [IQR 190-438] vs. 379 [IQR 235-503] mOsm/kg, P = 0.01) and higher urine volumes (3155 [IQR 2270-4295] vs. 1920 [IQR 1670-2960] ml/day, P = 0.02). Two cases of hyponatraemia occurred in HW group. No acute GFR effects were detected. In total 79% (519/672) of USG were submitted and 90% (468/519) were within target. Overall, 17% withdrew during the study.
Conclusion
DRINK demonstrated successful recruitment and adherence leading to separation between treatment arms in primary outcomes. These findings suggest a definitive trial assessing the impact of high water on kidney disease progression in ADPKD is feasible.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY-NC).
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