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

Sponsor
Universitas Sumatera Utara
Study ID
NCT07418541
Status
Not Yet Recruiting

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Conditions

  • Acute Kidney Injury
  • Septic Shock

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Norepinephrine — DRUG
    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.
  • Crystalloid Fluid Resuscitation — OTHER
    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.

Study Details

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.

Key Dates

First listed
Feb 18, 2026
Start date
Apr 23, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Early Fluid Resuscitation Plus Norepinephrine
    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.

Primary Outcome Measure

Occurrence of Acute Kidney Injury [ Time Frame: Within 48 hours after intervention ]

Central Contacts

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