Comparison of standard with individualised fluid replacement therapy in post-neurosurgical patients after a subarachnoid haemorrhage (Enteral Feed and Fluid Effect in a Controlled Trial of patients with SubArachnoid Haemorrhage) - The EFFECT-SAH pilot trial -

Abstract

Critically ill patients require variable and large amounts of intravenous fluids (IVF) to replace perioperative losses and maintain mean arterial pressure (MAP). This is particularly important in neurosurgical patients to prevent cerebral vasospasm after a subarachnoid haemorrhage (SAH). It is standard practice to prescribe these patients with 3 L of fluid per day (triple-H therapy) on admission. This can result in sodium and fluid overload which leads to poorer clinical outcomes. A previous audit showed that in some patients the 3 L standard fluid protocol lead to intravenous fluid (IVF) overload followed by enteral fluid restriction and thereby reducing nutritional intake especially in patients with low body weight. This pilot trial studied the effect of standard 3 L fluid therapy compared with individualised fluid therapy in acute subarachnoid patients post neurosurgery on clinical outcomes such as cumulative fluid balance, high dependency unit (HDU) length of stay, mortality, vasospasm and modified rankin score (MRS). The study included two groups i.e. Standard group and Individualised group. The standard group received 3 L of fluids while the individualised group received fluids calculated on their body weight requirements. Both groups were prescribed enteral feeding when oral intake did not meet nutritional requirements. Thirty patients with 15 in each group were recruited to a time series model (three-phase model). The study ceased on either day 30 of HDU admission or on discharge from the unit.The study received approval from the Northern-X Regional Ethics Committee and the ADHB Research Review Committee. Differences were demonstrated between groups for cumulative fluid balance (p=0.04). HDU length of stay was higher in the individualised group compared to standard group (p=0.02). The individualised group had fewer iv vasospasm events and mortality compared to the standard group. MRS was better in the individualised arm. The trial indicated a trend showing that standard 3 L fluid protocols provide no positive benefits, however the pilot informs a larger multi-centred randomised controlled trial (RCT) in the future to be able to demonstrate significant clinical outcomes and establish correlations between primary and secondary outcomes.