NCT07418541

Early Co-Administration of Crystalloid Fluid and Norepinephrine for Preventing Acute Kidney Injury in Septic Shock

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Universitas Sumatera Utara · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Septic Shock
• Acute Kidney Injury

Interventions

Type	Name	Description
DRUG	Norepinephrine	Norepinephrine is administered as an intravenous infusion initiated early in patients with septic shock at an initial dose of approximately 0.05 µg/kg/min. The dose is titrated based on hemodynamic response to achieve and maintain adequate mean arterial pressure in accordance with standard clinical practice.
OTHER	Crystalloid Fluid Resuscitation	Participants receive intravenous crystalloid fluid resuscitation at a total dose of 30 mL per kilogram of body weight as part of early management of septic shock. Fluid administration is provided according to institutional protocols and patient clinical condition.

Timeline

• Start date: 2026-04-23
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2026-02-18
• Last updated: 2026-02-18