TY - JOUR T1 - 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) JF - BMJ Open JO - BMJ Open DO - 10.1136/bmjopen-2017-018794 VL - 8 IS - 1 SP - e018794 AU - Annette T Y Wong AU - Carly Mannix AU - Jared J Grantham AU - Margaret Allman-Farinelli AU - Sunil V Badve AU - Neil Boudville AU - Karen Byth AU - Jessie Chan AU - Susan Coulshed AU - Marie E Edwards AU - Bradley J Erickson AU - Mangalee Fernando AU - Sheryl Foster AU - Imad Haloob AU - David C H Harris AU - Carmel M Hawley AU - Julie Hill AU - Kirsten Howard AU - Martin Howell AU - Simon H Jiang AU - David W Johnson AU - Timothy L Kline AU - Karthik Kumar AU - Vincent W Lee AU - Maureen Lonergan AU - Jun Mai AU - Philip McCloud AU - Anthony Peduto AU - Anna Rangan AU - Simon D Roger AU - Kamal Sud AU - Vincent Torres AU - Eswari Vliayuri AU - Gopala K Rangan Y1 - 2018/01/01 UR - http://bmjopen.bmj.com/content/8/1/e018794.abstract N2 - 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. ER -