Skip to main content

Table 3 Outcomes

From: Tolvaptan versus fluid restriction in acutely hospitalised patients with moderate-profound hyponatraemia (TVFR-HypoNa): design and implementation of an open-label randomised trial

Primary endpoint

• Change in serum sodium concentrations over time, from day 1 to day 4

Secondary endpoints

• Difference between groups of area under the curve of serial direct serum sodium measurements in mmol/L

• Serum sodium increment in the first 24 and 48 h

• Proportion of patients normalising serum sodium (defined as serum sodium ≥ 135 mmol/L)

• Length of hospital stay

• Requirement for serum sodium re-lowering with enteral or IV dextrose/water and/or desmopressin

o Main safety outcome: difference between rates of above-target correction of serum sodium leading to attenuation/reversal therapy (e.g. IV dextrose administration)

• Cognitive and functional measures at 24, 48 and 72 h (or discharge if sooner)

o Confusion Assessment Method Shortform (CAM-S) score

o Hyponatraemia symptom questionnaire score

o Timed Up and Go test score

• 30-day readmission rate

• Exit questionnaire treatment satisfaction score

• Serum sodium concentration 30 days after discharge

Back to article page

Trials

ISSN: 1745-6215