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临床试验/NCT07530653
NCT07530653尚未招募不适用

Delayed Resuscitation in Hemorrhagic Shock Due to Severe Injuries of the Torso in Low-resource Facilities of Latin America.

Hospital Departamental de Villavicencio1 个研究点 分布在 1 个国家目标入组 716 人开始时间: 2026年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
716
试验地点
1
主要终点
In-hospital mortality

研究概览

简要总结

This study will provide information on the quality of care in hemorrhagic shock of severe injuries in a limited resource facility of Latin America, the strategies of fluid resuscitation, and outcomes.

详细描述

Background / Introduction

Trauma remains a leading cause of mortality worldwide, particularly among young and economically productive populations, generating a disproportionate burden in terms of years of life lost, disability, and healthcare expenditures. Hemorrhagic shock is the most common cause of preventable death following trauma, especially within the first hours after injury. Despite advances in trauma systems and critical care, early mortality due to uncontrolled bleeding continues to pose a major clinical challenge.

Traditional resuscitation strategies have emphasized aggressive early fluid administration aimed at restoring normotension. However, growing evidence suggests that this approach may be physiologically detrimental in the setting of uncontrolled hemorrhage. Rapid volume expansion can dislodge forming clots, dilute coagulation factors, exacerbate acidosis, and contribute to the development of trauma-induced coagulopathy. These mechanisms are closely associated with the so-called "lethal triad" of trauma: hypothermia, acidosis, and coagulopathy, which significantly increases mortality risk.

In response to these concerns, the concept of delayed resuscitation, also referred to as permissive hypotension, has emerged as a damage control strategy. This approach aims to limit fluid administration until hemorrhage control is achieved, maintaining a lower-than-normal blood pressure sufficient for minimal organ perfusion while avoiding exacerbation of bleeding. Experimental models and clinical studies have suggested potential benefits, including reduced blood loss, lower transfusion requirements, and improved survival in selected patient populations.

However, the current body of evidence presents important limitations. Many studies have been conducted in high-resource settings with well-developed trauma systems, rapid surgical access, and availability of blood products. Furthermore, heterogeneity in study design, patient populations, injury patterns, and resuscitation protocols limits the generalizability of findings. Importantly, patients with traumatic brain injury, elderly individuals, and those with significant comorbidities may respond differently to hypotensive strategies, raising concerns regarding safety and applicability.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Major injuries.
  • Hypotension with a systolic blood pressure below 90 mmHg.
  • No previous hospital care.
  • Older than 16 years.

排除标准

  • Brain injuries.
  • Pregnancy.
  • Drowning.

研究组 & 干预措施

Immediate resuscitation

IV fluids > 1000 mL

干预措施: IV fluids more than 1,000 mL (Drug)

Delayed resuscitation

IV fluids lower than 1000 mL.

干预措施: Crystalloid below 1000 mL. (Drug)

结局指标

主要结局

In-hospital mortality

时间窗: 28 days

Mortality on discharge or before 28 days.

次要结局

  • Early mortality(24 hours.)
  • Coagulopathy(24 hours.)

研究者

发起方
Hospital Departamental de Villavicencio
申办方类型
Other
责任方
Principal Investigator
主要研究者

Norton Perez-Gutierrez, MD

ICU director

Hospital Departamental de Villavicencio

研究点 (1)

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