Outpatient Preoperative Parenteral Nutrition in Malnourished Surgical Patients

Официальное название

Outpatient Preoperative Parenteral Nutrition in Malnourished Surgical Patients: A Feasibility Study

Обзор

Malnutrition is common in surgical patients. Many studies have shown a clear association between malnutrition and poor surgical outcomes. Parenteral nutrition (PN) is a nutrition intervention that is given by vein and can be safely provided to malnourished patients. It contains carbohydrates, fats, and protein just like you would normally in your diet. Pre-operative PN is able to improve outcomes in surgical patients. However, pre-operative PN has traditionally required hospital admission which results in increased length of stay, hospital cost, and hospital-acquired infection. Moreover, in hospital pre-operative PN may not be feasible or prioritized when access to inpatient surgery beds is limited. Outpatient PN provides the opportunity to solve this problem. The feasibility and impact of outpatient PN in malnourished patients undergoing major surgery have not previously been studied. This study aims to evaluate the feasibility of outpatient pre-operative PN and its effect on patient's outcomes.

Вмешательства

• Другое Parenteral Nutrition
  Olimel 7.6% E 1000 ml will be infused over 4-5 hours at outpatient infusion clinic for 5-10 days within 14 days prior to surgery.
• Другое Standard Nutrition Care
  Participants will receive nutrition therapy by registered dietitians within 14 days prior to surgery. Patients with SGA B and SGA C will receive advanced nutrition care and specialized nutrition care, respectively.

Первичные конечные точки

• Rate of parenteral nutrition completion [Срок оценки: through study completion, an average of 1 year]
• Postoperative complications evaluated by Clavien-Dindo Classification [Срок оценки: through study completion, an average of 1 year]

Вторичные конечные точки (10)

• Length of hospital stay [Срок оценки: through study completion, an average of 1 year]
• Quality of life: Short Form (SF)-12 questionnaire [Срок оценки: 5-10 days during parenteral nutrition infusion]
• Body weight [Срок оценки: 5-10 days during parenteral nutrition infusion]
• Nutrition status [Срок оценки: 5-10 days during parenteral nutrition infusion]
• Muscle power [Срок оценки: 5-10 days during parenteral nutrition infusion]
• Cost-saving [Срок оценки: through study completion, an average of 1 year]
• Hospital readmission [Срок оценки: 30 days after discharge]
• Total energy from parenteral nutrition [Срок оценки: 5-10 days during parenteral nutrition infusion]
• Total protein from parenteral nutrition [Срок оценки: 5-10 days during parenteral nutrition infusion]
• Acceptability, appropriateness, and feasibility of intervention measured by Acceptability, Appropriateness, and Feasibility Questionnaire [Срок оценки: through study completion, an average of 1 year]

Критерии участия

Критерии включения

• Patients 18 years of age or older
• Patients screened at risk of malnutrition by Canadian Nutrition Screening Tool (CNST) and identified as malnourished by subjective global assessment (SGA) B or C

Критерии исключения

• Patients undergoing minor or laparoscopic surgery
• Pregnancy
• Patients with severe systemic diseases defined by American Society of Anesthesiologists (ASA) classification III to V
• Patients with diabetes mellitus
• Patients with planned palliative treatment

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 2 центра

• Royal Alexandra Hospital — Edmonton
• University of Alberta Hospital — Edmonton

Идентификаторы

NCT: NCT03926949 · 19G2208

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗