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Идёт набор NCT06539234

Angiotensin II Stress Test. Renin Kinetics During Treatment of Vasoplegic Shock With Angiotensin II.

— Наблюдательное Shock Vasoplegic Syndrome

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Shock, Vasoplegic Syndrome. 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
Словения
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

Angiotensin II Stress Test. Renin Kinetics During Treatment of Vasoplegic Shock With Angiotensin II in Relation to Hemodynamic Response to Treatment With Angiotensin II.

Обзор

Shock is a life-threatening condition which can cause multiple organ failure and even death. One characteristic of shock is low blood pressure which is managed with drugs called vasopressors. Most frequently used vasopressors are noradrenaline, vasopressin and recently also angiotensin II. Angiotensin II is present in the body and has a physiological role in maintaining blood pressure in healthy persons. Renin is an enzyme and a key factor in angiotensin II production in the body. In patients with shock, there is a lack of angiotensin II and an excess of renin in the body. Due to the literature renin has the potential to be a marker of severity of shock. Synthetic angiotensin II is used in patients with shock in whom we cannot normalize the blood pressure with noradrenaline and vasopressin. Regarding scientific data, the use of synthetic angiotensin II reduces the dose of noradrenaline and vasopressin and the incidence of acute kidney injury. The aim of our study is to find out what is the relation between the concentration of renin before and 6 hours after the start of using angiotensin II in patients with shock and their clinical outcome. Since not all patients with shock are responding to angiotensin II, the aim of our study is also to find out which patients could benefit most from synthetic angiotensin II.

Подробное описание

In patients with distributive shock (≥18 years) with noradrenaline \>0,3 mcg/kg/min and vasopressin \>0,03 IE/min not achieving an appropriate mean arterial pressure (65-85 mmHg) an angiotensin II infusion will be started at 20 ng/kg/min and after that adjusted to a max dose of 40 ng/kg/min if needed. Before the infusion and 6 hours after the start of angiotensin II infusion a blood sample will be drawn to determine the renin concentration. The primary outcome will be organ failure free days and ICU free days. Secondary outcome will be the need for vasopressors, dialysis, mechanical ventilation, trend of renin concentration.

Первичные конечные точки

  • organ failure free days [Срок оценки: 0-30 days]
  • ICU free days [Срок оценки: 0-30 days]
Вторичные конечные точки (4)
  • duration of the need for vasopressors [Срок оценки: 0-30 days]
  • mechanical ventilation need [Срок оценки: 0-30 days]
  • dyalisis need [Срок оценки: 0-30 days]
  • renin trend [Срок оценки: 0-6 hours]

Критерии участия

Критерии включения

  • patients with distributive shock lasting < 72 hours
  • a goal mean arterial pressure (65-85 mmHg) not achieved despite an infusion of at least noradrenaline 0.3 mcg/kg/min and vasopressin 0.03 IE/min
  • the patient did not get angiotensin II before
  • predicted survival is >24h
  • no limitations for active treatment

Критерии исключения

  • burns >20% body area
  • acute coronary syndrome
  • bronchospasm
  • liver disease (MELD ≥30)
  • severe acute bleeding (need for 4 or more units of concentrated erythrocyte)
  • acute mesenteric ischemia
  • aortic dissection
  • leucopenia <1000/mm3
  • pregnancy
  • Raynaud disease, systemic sclerosis, vasospastic disease
  • the need for daily dose of hydrocortisone 500 mg or more
  • ECMO

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

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Словения · 2 центра
  • Medical ICU, University Medical Centre Maribor — Maribor
  • Surgical ICU, University Medical Centre Maribor — Maribor

Публикации

  • Yehya N, Harhay MO, Curley MAQ, Schoenfeld DA, Reeder RW. Reappraisal of Ventilator-Free Days in Critical Care Research. Am J Respir Crit Care Med. 2019 Oct 1;200(7):828-836. doi: 10.1164/rccm.201810-2050CP. PMID 31034248
  • Auriemma CL, Taylor SP, Harhay MO, Courtright KR, Halpern SD. Hospital-Free Days: A Pragmatic and Patient-centered Outcome for Trials among Critically and Seriously Ill Patients. Am J Respir Crit Care Med. 2021 Oct 15;204(8):902-909. doi: 10.1164/rccm.202104-1063PP. No abstract available. PMID 34319848
  • De Backer D, Cecconi M, Chew MS, Hajjar L, Monnet X, Ospina-Tascon GA, Ostermann M, Pinsky MR, Vincent JL. A plea for personalization of the hemodynamic management of septic shock. Crit Care. 2022 Dec 1;26(1):372. doi: 10.1186/s13054-022-04255-y. PMID 36457089
  • Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Moller MH, Iwashyna T, Jacob S, PMID 34599691
  • Vincent JL, Singer M, Einav S, Moreno R, Wendon J, Teboul JL, Bakker J, Hernandez G, Annane D, de Man AME, Monnet X, Ranieri VM, Hamzaoui O, Takala J, Juffermans N, Chiche JD, Myatra SN, De Backer D. Equilibrating SSC guidelines with individualized care. Crit Care. 2021 Nov 17;25(1):397. doi: 10.1186/s13054-021-03813-0. No abstract available. PMID 34789298
  • Maslove DM, Tang B, Shankar-Hari M, Lawler PR, Angus DC, Baillie JK, Baron RM, Bauer M, Buchman TG, Calfee CS, Dos Santos CC, Giamarellos-Bourboulis EJ, Gordon AC, Kellum JA, Knight JC, Leligdowicz A, McAuley DF, McLean AS, Menon DK, Meyer NJ, Moldawer LL, Reddy K, Reilly JP, Russell JA, Sevransky JE, Seymour CW, Shapiro NI, Singer M, Summers C, Sweeney TE, Thompson BT, van der Poll T, Venkatesh B PMID 35715504
  • Suzuki Y, Ruiz-Ortega M, Lorenzo O, Ruperez M, Esteban V, Egido J. Inflammation and angiotensin II. Int J Biochem Cell Biol. 2003 Jun;35(6):881-900. doi: 10.1016/s1357-2725(02)00271-6. PMID 12676174
  • Laghlam D, Jozwiak M, Nguyen LS. Renin-Angiotensin-Aldosterone System and Immunomodulation: A State-of-the-Art Review. Cells. 2021 Jul 13;10(7):1767. doi: 10.3390/cells10071767. PMID 34359936

Идентификаторы

NCT: NCT06539234 · UKC-MB-KME-33/24

Первоисточники (государственные реестры)

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