Restricted versus liberal maintenance fluid Strategy in mechanically ventilated children: A open-label Randomized control trial

In paediatric critical care, maintaining intravascular volume is crucial for optimal organ perfusion. Fluid is the second most common drug prescribed to an intensive care setting after oxygen. It is a double-edged sword due to its narrow therapeutic index. Traditional Holliday-Segar (HS) formula for calculation of maintenance fluid overestimates daily requirement of mechanically ventilated children who are non-ambulatory and with significantly less insensible losses. Primary objective of this study is to assess effect of conservative maintenance fluid strategy (50% of HS formula) on mortality in mechanically ventilated children compared to liberal fluid strategy (70% of HS formula). It will be a single-centre, open-label, randomize controlled trial with an estimated sample size of 92 (1:1 allocation). Randomization sequence will be computer generated and executed through opaque, sealed envelopes. Children meeting the inclusion and exclusion criteria will be tracked through first 7 days of their PICU stay to assess for fluid overload, ventilator free days and multi-organ dysfunction. 28-day mortality will be recorded. Data analysis will be performed using IBM SPSS. Continuous variables will be described as median with interquartile range. Categorical variables will be described as proportions. Intention-to-treat analysis will be performed.