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临床试验/NCT07418541
NCT07418541尚未招募不适用

Early Co-Administration of 30 mL/kg Crystalloid Fluid and Norepinephrine for Preventing Acute Kidney Injury in Septic Shock: A Pretest-Posttest Clinical Study

Universitas Sumatera Utara0 个研究点目标入组 100 人开始时间: 2026年4月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
Occurrence of Acute Kidney Injury

研究概览

简要总结

Septic shock is a life-threatening condition that can cause severe circulatory failure and damage to vital organs, including the kidneys. One of the most serious complications of septic shock is acute kidney injury (AKI), which is associated with increased morbidity and mortality.

This study aims to evaluate the effect of early co-administration of crystalloid fluid resuscitation (30 mL/kg body weight) and norepinephrine on preventing acute kidney injury and improving hemodynamic stability in adult patients with septic shock. Patients will receive standard initial fluid resuscitation combined with early norepinephrine infusion according to a predefined clinical protocol.

Changes in blood pressure, urine output, and other hemodynamic parameters will be observed before and after the intervention. The findings of this study are expected to provide evidence to support early hemodynamic optimization strategies for reducing the risk of acute kidney injury in septic shock patients.

详细描述

This study is a pretest-posttest interventional clinical study designed to evaluate the effectiveness of early co-administration of crystalloid fluid resuscitation and norepinephrine in patients with septic shock. Septic shock is characterized by persistent hypotension requiring vasopressor therapy despite adequate fluid resuscitation and is associated with a high risk of acute kidney injury.

Eligible participants are adult patients diagnosed with septic shock who meet the study inclusion criteria. All participants will receive crystalloid fluid resuscitation at a dose of 30 mL/kg body weight, followed by early initiation of norepinephrine infusion at an initial dose of approximately 0.05 µg/kg/min, titrated according to hemodynamic response and clinical judgment.

Hemodynamic parameters, including mean arterial pressure, heart rate, oxygen saturation, urine output, and central venous pressure (when available), will be measured before and after the intervention. Renal function indicators will be monitored to assess the occurrence of early acute kidney injury.

The primary objective of this study is to evaluate the effect of early combined fluid resuscitation and norepinephrine administration on the prevention of acute kidney injury. Secondary objectives include assessment of changes in hemodynamic stability following the intervention. The results of this study are expected to contribute to evidence-based management strategies for septic shock in resource-limited clinical settings.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Adult patients aged 18 years or older.
  • Diagnosed with septic shock based on clinical criteria.
  • Require fluid resuscitation and vasopressor support.
  • Admitted to the intensive care unit or emergency department.
  • Have complete baseline clinical and hemodynamic data.

排除标准

  • Patients with end-stage renal disease or receiving chronic dialysis.
  • Known pregnancy.
  • History of severe chronic kidney disease.
  • Patients with limitations of care or do-not-resuscitate orders.
  • Incomplete clinical data for outcome assessment.

研究组 & 干预措施

Early Fluid Resuscitation Plus Norepinephrine

Experimental

Participants in this single study arm receive early crystalloid fluid resuscitation at a dose of 30 mL/kg body weight combined with early initiation of norepinephrine infusion. Norepinephrine is started at an initial dose of approximately 0.05 µg/kg/min and titrated according to hemodynamic response to achieve adequate mean arterial pressure. Hemodynamic and renal parameters are assessed before and after the intervention.

干预措施: Norepinephrine (Drug)

Early Fluid Resuscitation Plus Norepinephrine

Experimental

Participants in this single study arm receive early crystalloid fluid resuscitation at a dose of 30 mL/kg body weight combined with early initiation of norepinephrine infusion. Norepinephrine is started at an initial dose of approximately 0.05 µg/kg/min and titrated according to hemodynamic response to achieve adequate mean arterial pressure. Hemodynamic and renal parameters are assessed before and after the intervention.

干预措施: Crystalloid Fluid Resuscitation (Other)

结局指标

主要结局

Occurrence of Acute Kidney Injury

时间窗: Within 48 hours after intervention

Acute kidney injury is assessed based on changes in renal function parameters following early co-administration of crystalloid fluid resuscitation and norepinephrine in patients with septic shock.

次要结局

  • Change in Mean Arterial Pressure(Within 30 minutes after intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Irfan Julio Nasution

Principal Investigator - Department of Anesthesiology and Intensive Therapy, Universitas Sumatera Utara

Universitas Sumatera Utara

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