Abstract
BackgroundNutrition plays a major role in intensive care unit (ICU) treatment, influencing ICU length of stay and patient’s survival. If preferable enteral nutrition administration is not feasible, ESPEN and ASPEN guidelines recommend initiation of a supplemental parenteral route between the first and seventh day, but exact timing remains elusive. While rapid development in critical care enabled significant reduction in the mortality rate of ICU patients, this improvement also tripled the number of patients going to rehabilitation. Thus, it is quality of life after ICU that has become the subject of interest of clinicians and healthcare policy-makers. A growing body of evidence indicates that protein turnover in the early phase of critical illness may play a crucial role in the preservation of lean body mass. A negative protein balance may lead to muscle wasting that persists weeks and months after ICU stay, resulting in deterioration of physical functioning. Folliwing oncological gastrointestinal tract surgery, patients are threatened with negative protein turnover due to cancer and extensive surgical insult.MethodsThis is a multi-centre, single-blinded, randomised controlled trial. The study population includes patients admitted to ICU units after major oncological gastrointestinal surgery that require supplemental parenteral nutrition. After initiation of enteral nutrition, the intervention group receives remaining daily requirement via supplemental parenteral nutrition on the first day of ICU stay while the control group is not supplemented parenterally until the seventh day of ICU stay while enteral nutrition is gradually increased.Primary endpoint: long-term quality of life measured in the physical component score (PCS) of SF-36 questionnaire at 3 and 6 months after ICU admission.DiscussionTo our knowledge, this is the first trial to investigate the influence of early supplemental parenteral nutrition on long-term quality of life after major oncological gastrointestinal surgery. We assume that, particularly in this population of patients, early supplemental parenteral nutrition may increase the long-term quality of life. The study construction also allows establishment of patients’ PCS SF-36 score prior to surgery and mean change in PCS SF-36 score during the recovery period, which is rarely seen in studies on critically ill patients.Trial registrationClinicalTrials.gov: NCT03699371 registered on 12 October 2018.
Highlights
Nutrition plays a major role in intensive care unit (ICU) treatment, influencing ICU length of stay and patient’s survival
Interventions Intervention group The intervention group will receive enteral nutrition (EN) reaching up to 20% of daily nutritional requirements and early provision of up to 80% of their protein (2 g/kg/day or, in case of continuous renal replacement therapy (CRRT), 2.5 g/kg/day) and caloric (15–20 kcal/kg/day) needs in supplemental parenteral nutrition (SPN), which will be continued until day 7 of ICU stay for the purpose of the study
Early meeting of full nutritional requirements is rarely viable via the EN route alone, while adequate delivery of proteins might prevent the cascade of catabolism during the first days of ICU stay after extended surgery
Summary
Assignment of intervention Enrolment procedure All study participants will be enrolled from surgical departments by anaesthetic residents during presurgical assessment according to the inclusion and exclusion criteria (Table 1 and Fig. 1). Chronic liver failure (Child-Pugh scale B or C), e.g. secondary to drug or alcohol abuse 18 Participation in another interventional clinical trial within the previous 4 weeks 19. Clinical testing data a) Prior to enrolment, haemoglobin, platelet, Na+, K+, Ca, Cl–, Mg2+, P, triglyceride, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase and bilirubin levels, International Normalised Ratio, and activated partial thromboplastin time as well as presence of HIV, hepatitis B virus or hepatitis C virus will be assessed. Complementary to previous studies, the results of this trial might elucidate the optimal timing of SPN in patients recovering from oncological gastrointestinal tract surgery in the long-term setting. The duty of the Principal Investigator is to record these in the patient’s requisition form and inform the Local Ethical Committee in order to establish the causal relationship between the event and trial interventions. Dissemination policy We plan to share the results of our study with the scientific and clinical community by reporting it at conferences and by submission to a scientific journal for publication
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