Abstract:
INTRODUCTION:Sepsis is defined as detrimental immune response to an infection. This overwhelming reaction often abolishes a normal reconstitution of the immune cell homeostasis that in turn increases the risk for further complications. Recent studies revealed a favourable impact of ketone bodies on resolution of inflammation. Thus, a ketogenic diet may provide an easy-to-apply and cost-effective treatment option potentially alleviating sepsis-evoked harm. This study is designed to assess the feasibility, efficiency and safety of a ketogenic diet in septic patients. METHODS AND ANALYSIS:This monocentric study is a randomised, controlled and open-label trial, which is conducted on an intensive care unit of a German university hospital. As intervention enteral nutrition with reduced amount of carbohydrates (ketogenic) or standard enteral nutrition (control) is applied. The primary endpoint is the detection of ketone bodies in patients' blood and urine samples. As secondary endpoints, the impact on important safety-relevant issues (eg, glucose metabolism, lactate serum concentration, incidence of metabolic acidosis, thyroid function and 30-day mortality) and the effect on the immune system are analysed. ETHICS AND DISSEMINATION:The study has received the following approvals: Ethics Committee of the Medical Faculty of Ruhr-University Bochum (No. 18-6557-BR). Results will be made available to critical care survivors, their caregivers, the funders, the critical care societies and other researchers by publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBERS:German Clinical Trial Register (DRKS00017710); Universal Trial Number (U1111-1237-2493).
journal_name
BMJ Openjournal_title
BMJ openauthors
Rahmel T,Hübner M,Koos B,Wolf A,Willemsen KM,Strauß G,Effinger D,Adamzik M,Kreth Sdoi
10.1136/bmjopen-2020-038532subject
Has Abstractpub_date
2020-07-08 00:00:00pages
e038532issue
7issn
2044-6055pii
bmjopen-2020-038532journal_volume
10pub_type
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