Impact of carbohydrate-reduced nutrition in septic patients on ICU: study protocol for a prospective randomised controlled trial
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...
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BMJ Publishing Group
2020-07-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/7/e038532.full |
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| author | Tim Rahmel Michael Adamzik Max Hübner Björn Koos Alexander Wolf Katrin-Maria Willemsen Gabriele Strauß David Effinger Simone Kreth |
| author_facet | Tim Rahmel Michael Adamzik Max Hübner Björn Koos Alexander Wolf Katrin-Maria Willemsen Gabriele Strauß David Effinger Simone Kreth |
| author_sort | Tim Rahmel |
| collection | DOAJ |
| description | 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). |
| format | Article |
| id | doaj-art-dee7b3082292483a9a5f44920b459fd0 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-07-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-dee7b3082292483a9a5f44920b459fd02025-08-20T02:19:27ZengBMJ Publishing GroupBMJ Open2044-60552020-07-0110710.1136/bmjopen-2020-038532Impact of carbohydrate-reduced nutrition in septic patients on ICU: study protocol for a prospective randomised controlled trialTim Rahmel0Michael Adamzik1Max Hübner2Björn Koos3Alexander Wolf4Katrin-Maria Willemsen5Gabriele Strauß6David Effinger7Simone Kreth85 Clinic for Anesthesiology, Intensive Care and Pain Therapy, University Medical Center Knappschaftskrankenhaus Bochum, Bochum, GermanyDepartment of Anesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Knappschaftskrankenhaus, Ruhr University Bochum, Bochum, Nordrhein-Westfalen, GermanyFaculty of Medicine - LMU, Walter-Brendel Center of Experimental Medicine, München, GermanyKlinik für Anästhesiologie, Intensivmedizin und Schmerztherapie, Universitätsklinikum Knappschaftskrankenhaus Bochum, Bochum, GermanyKlinik für Anästhesiologie, Intensivmedizin und Schmerztherapie, Universitätsklinikum Knappschaftskrankenhaus Bochum, Bochum, GermanyKlinik für Anästhesiologie, Intensivmedizin und Schmerztherapie, Universitätsklinikum Knappschaftskrankenhaus Bochum, Bochum, GermanyFaculty of Medicine - LMU, Walter-Brendel Center of Experimental Medicine, München, GermanyFaculty of Medicine - LMU, Walter-Brendel Center of Experimental Medicine, München, GermanyFaculty of Medicine - LMU, Walter-Brendel Center of Experimental Medicine, München, GermanyIntroduction 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).https://bmjopen.bmj.com/content/10/7/e038532.full |
| spellingShingle | Tim Rahmel Michael Adamzik Max Hübner Björn Koos Alexander Wolf Katrin-Maria Willemsen Gabriele Strauß David Effinger Simone Kreth Impact of carbohydrate-reduced nutrition in septic patients on ICU: study protocol for a prospective randomised controlled trial BMJ Open |
| title | Impact of carbohydrate-reduced nutrition in septic patients on ICU: study protocol for a prospective randomised controlled trial |
| title_full | Impact of carbohydrate-reduced nutrition in septic patients on ICU: study protocol for a prospective randomised controlled trial |
| title_fullStr | Impact of carbohydrate-reduced nutrition in septic patients on ICU: study protocol for a prospective randomised controlled trial |
| title_full_unstemmed | Impact of carbohydrate-reduced nutrition in septic patients on ICU: study protocol for a prospective randomised controlled trial |
| title_short | Impact of carbohydrate-reduced nutrition in septic patients on ICU: study protocol for a prospective randomised controlled trial |
| title_sort | impact of carbohydrate reduced nutrition in septic patients on icu study protocol for a prospective randomised controlled trial |
| url | https://bmjopen.bmj.com/content/10/7/e038532.full |
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