Effect of Fasting Recommendations Among Patients Using GLP-1 Receptor Agonists

Официальное название

Effect of Fasting Recommendations on Residual Gastric Contents Among Patients Using Glucagon-like Peptide-1 Receptor Agonists: A Randomised Controlled Trial

Обзор

The aim of this randomised controlled trial is to determine the effect of a 24-hour clear liquid diet compared to standard fasting guidelines on the proportion of participants who present with increased residual gastric contents during their study visit. It also aims to determine the effect of a 24-hour clear liquid diet compared to standard fasting guidelines on: * Solid content or thick fluids * Patient-reported outcome measures (PROMs), including thirst, hunger, nausea, fatigue, and anxiety. * Compliance measures, including adherence with the intervention, time since last oral intake of solid foods, and time since last oral intake of clear liquids. We will enrol adults who are currently using any once-weekly glucagon-like peptide-1 receptor agonist (GLP-1RA) medication. Participants will be allocated in a 1:1 ratio to follow a 24-hour clear liquid diet or standard fasting guidelines prior to attending a study visit where participants will undergo a blinded gastric ultrasound assessment.

Подробное описание

GLP-1 RAs have had a transformative impact on the management of obesity, cardiovascular disease, and type 2 diabetes. Despite this, this class of medications pose a significant challenge in the perioperative setting, as GLP-1 RAs are known to increase patients' risk of presenting to surgery with residual gastric contents even when standard fasting guidance is adhered to. Such residual contents pose a risk for devastating complications if they are aspirated during surgery. In procedures such as upper endoscopy, where clear visualisation of the gastric tract is essential, the presence of residual contents in the stomach may result in procedures being aborted, leading to patients being exposed to additional risks associated with having to repeat the procedure. Despite the urgent need for clear guidance based on reliable evidence, healthcare professionals are currently practicing in an almost complete absence of evidence regarding the management of GLP-1 RAs in the perioperative period.

Our trial aims to address the uncertainty around pre-procedure management of patients using GLP-1 RAs by evaluating whether a 24-hour clear liquid diet can reduce the likelihood of increased residual gastric contents in patients using once-weekly GLP-1 RA medications, compared to the standard fasting guidelines currently recommended before elective procedures. Standard fasting guidelines, as defined by the ASA and ANZCA, recommend clear liquids up to 2 hours before anaesthesia, a light or low calorific meal up to 6 hours before anaesthesia, and fasting from fried foods, fatty foods, or meat for at least 8 hours prior to anaesthesia.The trial will also examine the effect of this more stringent fasting guidance on outcomes including thirst, hunger, nausea, fatigue, and anxiety, which impact both comfort and satisfaction among patients undergoing surgery.

Вмешательства

• Другое 24-hour clear liquid diet
  Participants randomly assigned to this arm will be instructed to follow a 24-hour clear liquid diet, defined as NPO for solids and last intake of clear liquids no less than 2 hours prior to the trial visit.
• Другое Standard fasting guidelines
  Participants randomly assigned to this arm will be instructed to follow the ASA and ANZCA standards for preoperative fasting prior to presenting for their trial visit. This requires participants to only consume clear liquids up to 2 hours, a light or low calorific meal up to 6 hours, and fasting from fried foods, fatty foods, or meat for at least 8 hours prior to the trial visit.

Первичные конечные точки

• Residual gastric contents [Срок оценки: Immediately following fasting intervention]

Вторичные конечные точки (9)

• Solid content or thick fluids [Срок оценки: Immediately following fasting intervention]
• Thirst [Срок оценки: Immediately following fasting intervention]
• Hunger [Срок оценки: Immediately following fasting intervention]
• Nausea [Срок оценки: Immediately following fasting intervention]
• Fatigue [Срок оценки: Immediately following fasting intervention]
• Anxiety [Срок оценки: Immediately following fasting intervention]
• Adherence to intervention [Срок оценки: Immediately following fasting intervention]
• Time since last oral intake of solid foods [Срок оценки: Immediately following fasting intervention]
• Time since last oral intake of clear liquids [Срок оценки: Immediately following fasting intervention]

Критерии участия

Критерии включения

• Age ≥18 years old at enrolment.
• Have regularly administered any type of once-weekly GLP-1 RA medication for a period of at least one month prior to randomisation.
• If allocated to follow standard fasting guidelines, willing to adhere to ASA and ANZCA preoperative fasting requirements. This requires participants to only consume clear liquids up to 2 hours, a light or low calorific meal up to 6 hours, and fasting from fried foods, fatty foods, or meat for at least 8 hours prior to the trial visit.
• If allocated to follow a 24-hour clear liquid diet, willing to adhere to nothing-by-mouth (NPO) for solids and last intake of clear liquids no less than 2 hours prior to the trial visit.
• Provide a signed and dated informed consent form for study participation in line with the requirements of the human research ethics committee (HREC) of the study site.

Критерии исключения

Participants meeting any of the following criteria, indicative of abnormal anatomy and not validated by gastric ultrasound, will be excluded from this trial:

• Has a recent history of gastrointestinal bleed within the previous 1 month from enrolment.
• Has a history of previous lower oesophageal or gastric surgery.
• Has a known abnormal upper gastrointestinal anatomy, including hiatus hernia or gastric tumours.

In addition, participants meeting any the of following criteria will be excluded from this trial:

• Participant reports having been previously diagnosed with a clinically significant gastric emptying abnormality such as gastroparesis.
• Participant reports concomitant use of insulin.
• Unable to assume the right lateral decubitus position required for gastric ultrasound assessment.
• Participant has difficulty fully understanding PICF or study materials due to a primary language other than English.

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

Двойное слепое

Основная цель

Профилактика

Центры проведения

Австралия · 2 центра

• Melbourne Gastro Oesophageal Surgery (MGOS) — Melbourne
• St Vincent's Hospital Melbourne — Melbourne

Публикации

• Practice Guidelines for Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration: Application to Healthy Patients Undergoing Elective Procedures: An Updated Report by the American Society of Anesthesiologists Task Force on Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration. Anesthesiology. 2017 Mar;126(3):3 PMID 28045707
• Joshi GP, Abdelmalak BB, Weigel WA, Harbell MW, Kuo CI, Soriano SG, Stricker PA, Tipton T, Grant MD, Marbella AM, Agarkar M, Blanck JF, Domino KB. 2023 American Society of Anesthesiologists Practice Guidelines for Preoperative Fasting: Carbohydrate-containing Clear Liquids with or without Protein, Chewing Gum, and Pediatric Fasting Duration-A Modular Update of the 2017 American Society of Anesthes PMID 36629465
• Perlas A, Van de Putte P, Van Houwe P, Chan VW. I-AIM framework for point-of-care gastric ultrasound. Br J Anaesth. 2016 Jan;116(1):7-11. doi: 10.1093/bja/aev113. Epub 2015 May 7. No abstract available. PMID 25951832
• Carey S, Waller J, Wang LY, Ferrie S. Qualifying thirst distress in the acute hospital setting-validation of a patient-reported outcome measure. Journal of Perioperative Nursing.2021;34(4):e38-e44.
• Flint A, Raben A, Blundell JE, Astrup A. Reproducibility, power and validity of visual analogue scales in assessment of appetite sensations in single test meal studies. Int J Obes Relat Metab Disord. 2000 Jan;24(1):38-48. doi: 10.1038/sj.ijo.0801083. PMID 10702749
• Boogaerts JG, Vanacker E, Seidel L, Albert A, Bardiau FM. Assessment of postoperative nausea using a visual analogue scale. Acta Anaesthesiol Scand. 2000 Apr;44(4):470-4. doi: 10.1034/j.1399-6576.2000.440420.x. PMID 10757584
• Glaus A. Assessment of fatigue in cancer and non-cancer patients and in healthy individuals. Support Care Cancer. 1993 Nov;1(6):305-15. doi: 10.1007/BF00364968. PMID 8156248
• Desrame J, Baize N, Anota A, Laribi K, Stefani L, Hjiej S, Nabirotchkina E, Zelek L, Choquet S. Fatigue visual analogue scale score correlates with quality of life in cancer patients receiving epoetin alfa (Sandoz) for chemotherapy-induced anaemia: The CIROCO study. Cancer Treat Res Commun. 2023;37:100781. doi: 10.1016/j.ctarc.2023.100781. Epub 2023 Nov 23. PMID 38039763

Идентификаторы

NCT: NCT06839248 · 2024/PID00396

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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