Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2017 Nov 28;7(11):e019199.
doi: 10.1136/bmjopen-2017-019199.

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

Yanfei Shen  1 , Xuping Cheng  1 , Manzhen Ying  1 , Weimin Zhang  1 , Xuandong Jiang  1 , Kailei Du  1
Affiliations
Randomized Controlled Trial

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

Yanfei Shen et al. BMJ Open. .

Abstract

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.

Keywords: anaesthesia in neurology; nutritional support.

PubMed Disclaimer

Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Enteral nutrition protocol for all included patients.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. Peeters W, van den Brande R, Polinder S, et al. . Epidemiology of traumatic brain injury in Europe. Acta Neurochir 2015;157:1683–96. 10.1007/s00701-015-2512-7 - DOI - PMC - PubMed
    1. Barlow KM. Traumatic brain injury. Handb Clin Neurol 2013;112:891–904. 10.1016/B978-0-444-52910-7.00011-8 - DOI - PubMed
    1. Young B, Ott L, Yingling B, et al. . Nutrition and brain injury. J Neurotrauma 1992;9:S375–83. - PubMed
    1. Jolliet P, Pichard C, Biolo G, et al. . Enteral nutrition in intensive care patients: a practical approach. Clin Nutr 1999;18:47–56. 10.1016/S0261-5614(99)80049-1 - DOI - PubMed
    1. Seule M, Brunner T, Mack A, et al. . Neurosurgical and intensive care management of traumatic brain injury. Facial Plast Surg 2015;31:325–31. 10.1055/s-0035-1562884 - DOI - PubMed

Publication types

LinkOut - more resources