Tokyo, Nov. 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059676) titled 'A Retrospective Study on the Implementation and Outcomes of the Revised Nutrition Protocol in Intensive Care Unit Patients' on Nov. 7.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Historical

Primary Sponsor: Institute - Tohoku University Hospital

Condition: Condition - Adult patients(over 18 years old) admitted to the intensive care unit (ICU) Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - The aim of this study is to clarify the incidence and characteristics of gastrointestinal adverse events under the implementation of a standardized nutrition protocol in critically ill patients. Specifically we will evaluate the incidence and temporal trends of gastrointestinal symptoms such as constipation diarrhea and vomiting during enteral nutrition and assess their association with the amount of nutritional intake. As secondary analyses we will calculate each patients nutritional adequacy rate (the ratio of administered to required energy and protein intake) and assess the protocol achievement level in our ICU. These findings will help identify current challenges and guide improvements in enteral nutrition procedures and preventive measures for gastrointestinal complications. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Intervention period: January 1 2022 December 31 2023 (Old nutrition protocol group approximately 200 patients) January 1 2024 December 31 2025 (New nutrition protocol group approximately 100 patients) Patients are managed according to institutional enteral nutrition protocols. The new protocol includes earlier initiation stepwise dose escalation and use of fiber-containing formulas when tolerated.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Diagnosis: all eligible ICU cases Disease stage: all stages included Age over 18 years at enrollment All sexes included Patients admitted to the ICU during the study period Key exclusion criteria - Patients deemed unsuitable for the nutrition protocol by the attending physician Patients with DNAR orders or those receiving palliative treatment Patients under 18 years of age Target Size - 300

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2022 Year 01 Month 01 Day Anticipated trial start date - 2025 Year 12 Month 01 Day Last follow-up date - 2027 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068158

Disclaimer: Curated by HT Syndication.