Evidence map›Paper›PMID 31665476›Full record

Trial reportQJM : monthly journal of the Association of Physicians2020

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

R El-Damanawi, M Lee, T Harris, L B Cowley, S Bond, H Pavey, R N Sandford, I B Wilkinson, F E Karet Frankl, T F Hiemstra

Erratum issuedOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in QJM : monthly journal of the Association of Physicians, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
2.7field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 25 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 2 institutions in 1 country.

R El-DamanawiDivision of Experimental Medicine and Immunotherapeutics, Department of Medicine, University of Cambridge, Cambridge.
M LeeDivision of Anaesthesia, Department of Medicine, University of Cambridge, Cambridge.
T HarrisPKD Charity, 91 Royal College, London.
L B CowleyCambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge.
S BondCambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge.
H PaveyCambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge.
R N SandfordDepartment of Medical Genetics, University of Cambridge, Hills Road, Cambridge, UK.
I B WilkinsonDivision of Experimental Medicine and Immunotherapeutics, Department of Medicine, University of Cambridge, Cambridge.
F E Karet FranklDepartment of Medical Genetics, University of Cambridge, Hills Road, Cambridge, UK.
T F HiemstraDivision of Experimental Medicine and Immunotherapeutics, Department of Medicine, University of Cambridge, Cambridge.
Cambridge University Hospitals NHS Foundation Trust · GBUniversity of Cambridge · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundVasopressin 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.

aimsAssess the feasibility of a definitive randomized high water intake trial in ADPKD.

methodsIn 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.

resultsWe 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.

conclusionDRINK 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.

Indexed as

DrinkingPolycystic Kidney, Autosomal DominantWaterAdultFeasibility StudiesFemaleGlomerular Filtration RateHumansMaleMiddle AgedProspective StudiesTreatment OutcomeVasopressinsYoung AdultVasopressinsWater

Identifiers

PMID31665476
PMCPMC7133783
OpenAlexW2982586187

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.