High water vs. ad libitum water intake for autosomal dominant polycystic kidney disease: a randomized controlled feasibility trial.

Autor:	El-Damanawi R; Division of Experimental Medicine and Immunotherapeutics, Department of Medicine, University of Cambridge, Cambridge.; Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge., Lee M; Division of Anaesthesia, Department of Medicine, University of Cambridge, Cambridge., Harris T; PKD Charity, 91 Royal College, London., Cowley LB; Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge.; Patient Led Research Hub, Cambridge NIHR Biomedical Research Centre, Cambridge., Bond S; Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge., Pavey H; Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge., Sandford RN; Department of Medical Genetics, University of Cambridge, Hills Road, Cambridge, UK., Wilkinson IB; Division of Experimental Medicine and Immunotherapeutics, Department of Medicine, University of Cambridge, Cambridge.; Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge., Karet Frankl FE; Department of Medical Genetics, University of Cambridge, Hills Road, Cambridge, UK., Hiemstra TF; Division of Experimental Medicine and Immunotherapeutics, Department of Medicine, University of Cambridge, Cambridge.; Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge.
Jazyk:	angličtina
Zdroj:	QJM : monthly journal of the Association of Physicians [QJM] 2020 Apr 01; Vol. 113 (4), pp. 258-265.
DOI:	10.1093/qjmed/hcz278
Abstrakt:	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. (© The Author(s) 2019. Published by Oxford University Press on behalf of the Association of Physicians.)
Databáze:	MEDLINE
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