| Title {1} | Tolvaptan versus fluid restriction in acutely hospitalised patients with moderate-severe hyponatraemia (TVFR-HypoNa): Design and implementation of an open-label randomised trial |
| Trial registration {2a and 2b}. | Australia and New Zealand Clinical Trials Registry ACTRN12619001683123. Registered 2 December 2019. |
| Protocol version {3} | 16 April 2021, Version 16 |
| Funding {4} |
Investigator-initiated trial. Otsuka Australia Pharmaceutical (maker of tolvaptan) have agreed to provide financial support to reimburse study drug purchase and expenses. National Health and Medical Research Council of Australia has awarded a postgraduate research scholarship to AMW for financial support during PhD candidature. |
| Author details {5a} |
Dr Annabelle M Warren MBBS Corresponding author – annabelle.warren@austin.org.au Prof Mathis Grossmann PhD Prof Rudolf Hoermann PhD Prof Jeffrey D Zajac PhD Dr Nicholas Russell MBBS Affiliations above |
| Name and contact information for the trial sponsor {5b} |
The University of Melbourne Department of Medicine, Austin Health Level 7, Lance Townsend Building 145 Studley Rd, Heidelberg Victoria, 3084, Australia |
| Role of sponsor {5c} | The sponsor (The University of Melbourne) and the funding sources (Otsuka Australia Pharmaceutical and National Health and Medical Research Council of Australia) do not have any role in study design, data collection, analysis or interpretation, nor in decision to submit the report for publication. |