Doppler Echocardiography Versus Clinical Targets Guided Therapy on the Outcome of Postpartum Septic Shock.

Официальное название

Doppler Echocardiography Versus Clinical Targets Guided Therapy on the Outcome of Postpartum Septic Shock, a Randomized Controlled Trial

Обзор

Postpartum sepsis is widely known as a preventable main cause of maternal morbidity and mortality. According to the World Health Organization, approximately 11% of the estimated maternal deaths worldwide were attributed to sepsis. Recent global assessments indicate that obstetric infections rank as the third most prevalent cause of maternal death, with a prevalence mainly observed in low- and middle-income nations.

Подробное описание

The management of septic shock is a major medical concern. Early goal-directed therapy emerged as a novel approach for reducing sepsis mortality and was incorporated into Surviving Sepsis Campaign guidelines in 2012. Early detection of sepsis, rapid initiation of antibiotics and effective resuscitation with fluids, vasopressors, and inotropes were important concerns. However, many randomized trials were done to examine the effect of EGDT on morbidity and mortality and showed that EGDT was not associated with a significant reduction in mortality in patients with septic shock compared to usual care. That it wasn't addressed in recent guidelines in 2016 and 2021.

Вмешательства

• Процедура a clinically guided resuscitation protocol,
  a clinically guided resuscitation protocol, derived from EGDT and modified to match with the latest survival sepsis campaign guidelines
• Процедура a transthoracic bedside focused echocardiographic assessment
  a transthoracic bedside focused echocardiographic assessment of the patient will be done, as a baseline ECHO in a three-step approach to monitor hemodynamics using Logiq P7, S5-1 ECHO probe;

Первичные конечные точки

• SOFA score [Срок оценки: 48 hours.]

Критерии участия

Критерии включения

• postpartum women, within 6 weeks following delivery
• meeting the third international consensus definitions for septic Shock (2016) (Sepsis-3): acute persisting hypotension requiring vasopressors to maintain mean arterial pressure (MAP) ≥ 65 mm Hg and having a serum lactate > 2 mmol/L (18 mg/dL) despite adequate volume resuscitation

Критерии исключения

• Patient refusal
• History of any chronic cardiac disease
• Requirement for immediate surgery
• Hypotension attributable to another cause
• Do-not-resuscitate status
• Contraindication to central venous catheter placement
• Difficult transthoracic echocardiographic evaluation
• Primary cardiogenic cause of shock, instead of sepsis.

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

Тройное слепое

Основная цель

Профилактика

Центры проведения

Египет · 1 центр

• woman health hospital , Assiut university — Asyut

Публикации

• Mouncey PR, Osborn TM, Power GS, Harrison DA, Sadique MZ, Grieve RD, Jahan R, Harvey SE, Bell D, Bion JF, Coats TJ, Singer M, Young JD, Rowan KM; ProMISe Trial Investigators. Trial of early, goal-directed resuscitation for septic shock. N Engl J Med. 2015 Apr 2;372(14):1301-11. doi: 10.1056/NEJMoa1500896. Epub 2015 Mar 17. PMID 25776532
• Hernandez G, Ospina-Tascon GA, Damiani LP, Estenssoro E, Dubin A, Hurtado J, Friedman G, Castro R, Alegria L, Teboul JL, Cecconi M, Ferri G, Jibaja M, Pairumani R, Fernandez P, Barahona D, Granda-Luna V, Cavalcanti AB, Bakker J; The ANDROMEDA SHOCK Investigators and the Latin America Intensive Care Network (LIVEN); Hernandez G, Ospina-Tascon G, Petri Damiani L, Estenssoro E, Dubin A, Hurtado J, Fr PMID 30772908

Идентификаторы

NCT: NCT06757985 · Doppler echocardiography

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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