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Идёт набор NCT06361238

Liraglutide in Preventing Delirium in Diabetic Elderly After Cardiac Surgery

Фаза III С лечением Delirium, Postoperative

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Liraglutide injection, Placebo injection.
Кому может быть актуально
Состояния в реестре: Delirium, Postoperative. Базовые параметры: от 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Perioperative Application of Liraglutide for the Prevention of Postoperative Delirium Among Elderly Patients with Type 2 Diabetes Undergoing Cardiac Surgery: a Single-Center Randomized Controlled Study

Обзор

This study aims to clarify the preventive effect of perioperative liraglutide application on postoperative delirium in elderly patients with Type 2 diabetes undergoing cardiac surgery.

Подробное описание

Delirium is the most prevalent neurological complication following cardiac surgery. It is characterized by an acute and fluctuating disturbance in consciousness, attention, and cognitive function. The incidence of delirium post-cardiac surgery ranges between 11% and 46%. It is closely linked to increased postoperative mortality, extended hospital stays, higher healthcare costs, and long-term cognitive impairment. Currently, it is widely recognized that the development of delirium is influenced by multiple factors, including advanced age, diabetes, surgical and anesthetic techniques, depression, baseline cognitive function, and infections, among others.

Inflammatory responses, crucial for protecting against external or internal threats, can, following surgery, lead to neuroinflammation and neurological damage due to elevated postoperative inflammatory markers and blood-brain barrier disruption. The involvement of microglia and astrocytes, key players in the central nervous system's immune response, has been identified in mediating postoperative delirium, making them potential targets for prevention.

Liraglutide, a Glucagon-like peptide-1 receptor agonist primarily used for treating Type 2 diabetes, has shown promise in mitigating neurocognitive damage associated with diabetes and Alzheimer's disease, suggesting its potential in preventing postoperative delirium in cardiac surgery patients with Type 2 diabetes. Preliminary animal studies and a randomized controlled trial indicate that perioperative liraglutide application could reduce the incidence of postoperative delirium by inhibiting glial activation and the subsequent neuroinflammatory response. However, differences in patient demographics, disease severity, and dosing in previous studies highlight the need for further investigation.

The study aims to investigate whether the perioperative administration of liraglutide can prevent the onset of postoperative delirium in elderly patients with Type 2 diabetes undergoing cardiac surgery. Secondary objectives include assessing the impact on the severity and duration of delirium, cognitive function, anxiety, depression, cardiac function, cardiovascular events, ICU stay, mechanical ventilation duration, and levels of serum markers for brain injury, inflammation, myocardial damage, and cardiac function.

Вмешательства

  • Препарат Liraglutide injection
    Subcutaneous injection of liraglutide: 0.6 mg administered the day before surgery, 1.8 mg administered post-anesthesia induction on the day of surgery, followed by 0.6 mg daily for the first three postoperative days.
  • Препарат Placebo injection
    Subcutaneous injection of Placebo: the same volume as liraglutide administrated at the corresponding times.

Первичные конечные точки

  • The incidence of delirium [Срок оценки: One day before surgery and within the first seven days after surgery.]
Вторичные конечные точки (12)
  • The severity of delirium [Срок оценки: One day before surgery and within the first seven days after surgery.]
  • Cognitive function [Срок оценки: One day before surgery; one week after surgery or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.]
  • Anxiety [Срок оценки: One day before surgery; one week after surgery or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.]
  • Depression [Срок оценки: One day before surgery; one week after surgery or at the date of discharge; and at 3 months, 6 months, and 1 year postoperatively.]
  • Duration of ICU stay [Срок оценки: The time from transfer into the ICU to discharge from the ICU, assessed up to 12months.]
  • Mechanical ventilation time [Срок оценки: The time from tracheal intubation to the removal of the tracheal tube, assessed up to 12months.]
  • Duration of hospital stay [Срок оценки: The time from hospital admission to discharge, assessed up to 12months.]
  • In-hospital mortality [Срок оценки: The time from hospital admission to discharge, assessed up to 12months.]
  • Incidence of adverse events [Срок оценки: One day preoperatively to three days Postoperatively.]
  • Rate of major cardiovascular adverse events [Срок оценки: Within 1 year post-surgery (including cardiovascular death, myocardial infarction, and stroke)]
  • Serum levels of NSE [Срок оценки: One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively]
  • Serum levels of CRP [Срок оценки: One day preoperatively; immediately after admission to ICU; 3 days and 7 days postoperatively]

Критерии участия

Критерии включения

  • Age ≥ 60 years
  • Type 2 diabetes
  • Patients undergoing elective cardiac surgery

Критерии исключения

  • History of neurological or psychiatric disorders, such as schizophrenia, epilepsy, Parkinson's disease, severe dementia, etc
  • Patients with communication difficulties, such as severe visual, auditory, or speech impairments
  • History of central nervous system damage or surgery
  • Cardiac function NYHA Class IV
  • Severe liver dysfunction (Child-Pugh Class C)
  • Severe renal failure requiring renal replacement therapy
  • History of pancreatitis
  • Type 1 diabetes
  • Patients whose blood sugar is difficult to control within 4-8 mmol/L during the screening period
  • Patients with medullary thyroid carcinoma or a family history of it
  • Pregnant or breastfeeding women
  • Intolerance or allergy to liraglutide
  • Previous use of GLP-1A and SGLT2i
  • Patients who refuse to sign the informed consent

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
Лечение

Центры проведения

Китай · 1 центр
  • Wenxue liu — Нанкин

Идентификаторы

NCT: NCT06361238 · 2023-LCYJ-PY-21

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗