Early low-energy versus high-energy enteral nutrition support in patients with traumatic intracerebral haemorrhage: protocol for a randomised controlled trial

BACKGROUND: Early enteral nutrition (EN) is associated with shorter hospital stay and lower infection and mortality rates in patients with intracerebral haemorrhage. However, high-energy support always causes clinical complications, such as diarrhoea and aspiration pneumonia, and the true benefit of high-energy support in these patients has not been investigated. The appropriate amount of energy support still needs further investigation. Therefore, we are performing a randomised controlled trial to investigate whether early low-energy EN can decrease mortality and feeding-related complications and improve neurological outcomes as compared with high-energy EN in traumatic intracerebral haemorrhage (TICH) patients. METHODS/ANALYSIS: This is a randomised, single-blind clinical trial performed in one teaching hospital. 220 TICH patients will be randomly allocated to one of two groups in a 1:1 ratio: an intervention group, and a control group. The intervention group will receive early low-energy EN (10 kcal/kg/day) and the control group will receive high-energy EN (25 kcal/kg/day) for 7 days. All these patients will be followed up for 90 days. The primary outcome is all-cause 90-day mortality. Secondary outcomes include the modified Rankin score, Glasgow Outcome Scale (GOS) and the National Institutes of Health Stroke Scale (NIHSS). Outcomes will be assessed at admission, 7, 30 and 90 days after onset of this trial. The safety of EN strategies will be assessed every day during hospitalisation. ETHICS AND DISSEMINATION: The trial will be conducted in accordance with the Declaration of Helsinki and has been approved by the ethics committee of Dongyang People’s Hospital. The findings will be published in peer-reviewed medical journals. TRIAL REGISTRATION NUMBER: ChiCTR-INR-17011384; Pre-results.