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Набор скоро начнётся NCT07627360

PRO STRESS Trial: Proactive Low-Dose Norepinephrine to Reduce Intraoperative Fluid Administration in Patients at High-Risk for Postoperative Pulmonary Complications Undergoing Laparoscopic Abdominal Surgery

Без фазы С лечением Intraoperative Hypotension Postoperative Pulmonary Complications (PPCs) Fluid Over-load

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: Norepinephrine, Placebo.
Кому может быть актуально
Состояния в реестре: Intraoperative Hypotension, Postoperative Pulmonary Complications (PPCs), Fluid Over-load. Базовые параметры: от 18 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
Египет
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Proactive Low-Dose Norepinephrine to Reduce Intraoperative Fluid Administration in Patients at High-Risk for Postoperative Pulmonary Complications Undergoing Laparoscopic Abdominal Surgery: A Randomized Controlled Trial

Обзор

Intraoperative hypotension is commonly treated with fluid administration; however, excessive fluid therapy may contribute to postoperative pulmonary complications. This randomized double-blind controlled trial evaluates whether proactive administration of fixed low-dose norepinephrine reduces intraoperative crystalloid administration while maintaining hemodynamic stability in high-risk patients undergoing laparoscopic abdominal surgery. One hundred and thirty patients will be randomized to receive either norepinephrine infusion (0.03 µg/kg/min) or placebo from induction until skin closure within a protocolized hemodynamic strategy guided by mean arterial pressure and pulse pressure variation.

Вмешательства

  • Препарат Norepinephrine
    Continuous norepinephrine infusion administered at a fixed dose of 0.03 µg/kg/min from induction of anesthesia until skin closure.
  • Другое Placebo
    Equivalent volume normal saline infusion administered from induction of anesthesia until skin closure at the same infusion rate as the active intervention to maintain blinding within a protocolized hemodynamic management strategy.

Первичные конечные точки

  • Total intraoperative crystalloid administration [Срок оценки: From induction of anesthesia until skin closure (intraoperative period)]
Вторичные конечные точки (10)
  • Number of Participants with Postoperative Pulmonary Complications [Срок оценки: Within seven postoperative days]
  • Number of Participants With Acute Kidney Injury [Срок оценки: Within seven postoperative days]
  • Lactate Levels [Срок оценки: After induction of anesthesia, at the end of surgery, and 24 hours postoperatively]
  • Urine Output [Срок оценки: From induction of anesthesia until skin closure (Intraoperative period)]
  • Intraoperative Blood Loss [Срок оценки: From surgical incision until skin closure (Intraoperative period)]
  • Duration of Rescue Norepinephrine Requirement [Срок оценки: From induction of anesthesia until skin closure (Intraoperative period)]
  • Duration of Intraoperative Hypotension [Срок оценки: From induction of anesthesia until skin closure (Intraoperative period)]
  • Number of Participants Admitted to the Intensive Care Unit [Срок оценки: Within seven postoperative days]
  • Duration of Postoperative Hospital Stay [Срок оценки: Within seven postoperative days]
  • Number of Participants With Postoperative Surgical Complications [Срок оценки: Within seven postoperative days]

Критерии участия

Критерии включения

  • Adult patients aged 18 years or older.
  • American Society of Anesthesiologists (ASA) physical status I-III.
  • Scheduled for elective laparoscopic major abdominal surgery under general anesthesia with an expected duration greater than 2 hours.
  • Patients with ARISCAT score ≥ 45 indicating high risk for postoperative pulmonary complications.

Критерии исключения

  • Known hypersensitivity to norepinephrine.
  • Severe left ventricular dysfunction with ejection fraction < 35%.
  • Significant cardiac arrhythmia.
  • Uncontrolled hypertension defined as systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg.
  • End-stage renal disease.
  • Requirement for vasopressor support before induction of anesthesia.
  • Emergency surgery.

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
Четверное слепое
Основная цель
Лечение

Центры проведения

Египет · 1 центр
  • Suez Canal University Hospitals — Ismailia

Публикации

  • Persichini R, Lai C, Teboul JL, Adda I, Guerin L, Monnet X. Venous return and mean systemic filling pressure: physiology and clinical applications. Crit Care. 2022 May 24;26(1):150. doi: 10.1186/s13054-022-04024-x. PMID 35610620
  • Felippe VA, Codeceira R, Irigaray M, Sckaff M, Wegner B, Nascimento T, Darcy C, Dutra L, Santiago B, Buchmann J, Lessa MA. Non-invasive goal-directed fluid therapy with the pleth variability index (PVI): a systematic review and meta-analysis. J Clin Monit Comput. 2025 Oct;39(5):917-927. doi: 10.1007/s10877-025-01334-7. Epub 2025 Aug 8. PMID 40778974
  • Cecconi M, Hofer C, Teboul JL, Pettila V, Wilkman E, Molnar Z, Della Rocca G, Aldecoa C, Artigas A, Jog S, Sander M, Spies C, Lefrant JY, De Backer D; FENICE Investigators; ESICM Trial Group. Fluid challenges in intensive care: the FENICE study: A global inception cohort study. Intensive Care Med. 2015 Sep;41(9):1529-37. doi: 10.1007/s00134-015-3850-x. Epub 2015 Jul 11. PMID 26162676
  • Canet J, Gallart L, Gomar C, Paluzie G, Valles J, Castillo J, Sabate S, Mazo V, Briones Z, Sanchis J; ARISCAT Group. Prediction of postoperative pulmonary complications in a population-based surgical cohort. Anesthesiology. 2010 Dec;113(6):1338-50. doi: 10.1097/ALN.0b013e3181fc6e0a. PMID 21045639
  • Cannesson M, Le Manach Y, Hofer CK, Goarin JP, Lehot JJ, Vallet B, Tavernier B. Assessing the diagnostic accuracy of pulse pressure variations for the prediction of fluid responsiveness: a "gray zone" approach. Anesthesiology. 2011 Aug;115(2):231-41. doi: 10.1097/ALN.0b013e318225b80a. PMID 21705869
  • Myles PS, Bellomo R, Corcoran T, Forbes A, Peyton P, Story D, Christophi C, Leslie K, McGuinness S, Parke R, Serpell J, Chan MTV, Painter T, McCluskey S, Minto G, Wallace S; Australian and New Zealand College of Anaesthetists Clinical Trials Network and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Restrictive versus Liberal Fluid Therapy for Major Abdominal Surgery. PMID 29742967

Идентификаторы

NCT: NCT07627360 · 6476# · 6476#

Первоисточники (государственные реестры)

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