跳至主要内容
临床试验/CTRI/2025/07/090571
CTRI/2025/07/090571招募中不适用

A prospective observational Study evaluating the impact of combining the One-Hour Sepsis Bundle and Point-of-Care Ultrasound (POCUS) in Sepsis and Septic Shock Patients presenting to Emergency Department in a Tertiary Care Hospital, in Manipur

MUHAMMED SHADIL K E1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2025年7月16日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
110
试验地点
1
主要终点
To evaluate the impact of combining the 1-hour sepsis bundle with POCUS on clinical outcomes (change in qSOFA, NEWS2, Lactate and Blood Pressure (MAP) ) in patients with sepsis or septic shock presenting to the Emergency Department.

研究概览

简要总结

Sepsis and septic shock remain leading causes of morbidity and mortality worldwide. Early identification and prompt treatment are critical to improving outcomes.This thesis aims to evaluate the impact of combining the 1-hour sepsis bundle with POCUS in the management of sepsis and septic shock patients presenting to Emergency Department in a tertiary care hospital, assessing its effects on patient outcomes, time to intervention, and clinical decision-making The study will involve Patients presenting to the ED with suspected sepsis or septic shock based on clinical criteria (e.g. qSOFA,NEWS2 score).It is anticipated that the use of POCUS in conjunction with the 1-hour sepsis bundle will result in Quicker identification and treatment of sepsis, Improved fluid resuscitation and cardiac optimization, More efficient management of septic shock.Data will be analyzed using appropriate statistical methods, adjusting for confounders and handling missing data with multiple imputation. This study aims to evaluate the impact of combining the 1-hour sepsis bundle with POCUS in the management of sepsis and septic shock patients presenting to Emergency Department and results of the study may ultimately contribute to evidence-based guidelines in the field of Emergency Medicine.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients presenting to the ED with suspected sepsis or septic shock based on clinical criteria (e.g. qSOFA,NEWS2 score).

排除标准

  • Patients (close relatives in case of unconscious patients) who refuse to give consent;Patients with age less than18 years and more than 65 years;Pregnant women;Known terminal illness with a prognosis of less than 6 months;Contraindications to ultrasound (e.g., extensive body surface area edema);Patients with spinal cord injury.

结局指标

主要结局

To evaluate the impact of combining the 1-hour sepsis bundle with POCUS on clinical outcomes (change in qSOFA, NEWS2, Lactate and Blood Pressure (MAP) ) in patients with sepsis or septic shock presenting to the Emergency Department.

时间窗: Period of one and half | years from june 2025 to December 2026.

次要结局

  • 1) To assess the time to intervention (antibiotics, fluids, vasopressors) in sepsis and septic shock patients.(2) To evaluate the accuracy and utility of POCUS in assessing volume status, cardiac function, and identifying potential sources of infection in septic patients.)

研究者

发起方
MUHAMMED SHADIL K E
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

MUHAMMED SHADIL K E

Shija Hospitals and Research Institute

研究点 (1)

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