RT Journal Article
SR Electronic
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
FD British Medical Journal Publishing Group
SP e018794
DO 10.1136/bmjopen-2017-018794
VO 8
IS 1
A1 Annette T Y Wong
A1 Carly Mannix
A1 Jared J Grantham
A1 Margaret Allman-Farinelli
A1 Sunil V Badve
A1 Neil Boudville
A1 Karen Byth
A1 Jessie Chan
A1 Susan Coulshed
A1 Marie E Edwards
A1 Bradley J Erickson
A1 Mangalee Fernando
A1 Sheryl Foster
A1 Imad Haloob
A1 David C H Harris
A1 Carmel M Hawley
A1 Julie Hill
A1 Kirsten Howard
A1 Martin Howell
A1 Simon H Jiang
A1 David W Johnson
A1 Timothy L Kline
A1 Karthik Kumar
A1 Vincent W Lee
A1 Maureen Lonergan
A1 Jun Mai
A1 Philip McCloud
A1 Anthony Peduto
A1 Anna Rangan
A1 Simon D Roger
A1 Kamal Sud
A1 Vincent Torres
A1 Eswari Vliayuri
A1 Gopala K Rangan
YR 2018
UL http://bmjopen.bmj.com/content/8/1/e018794.abstract
AB 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.