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NCT Number: NCT07418541

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: Noradrenaline

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.

Other names: Intravenous Crystalloid Fluids

Primary outcomes

  1. Occurrence of Acute Kidney Injury

    Time frame: 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.

Secondary outcomes

  1. Change in Mean Arterial Pressure

    Time frame: Within 30 minutes after intervention

    Change in mean arterial pressure measured before and after administration of crystalloid fluid and norepinephrine.

Study contacts

Contact information is provided by the study sponsor or research team.

Irfan Julio Nasution, MD

CONTACT

[email protected]

+6285296993309

Sponsors and collaborators

Lead sponsor

Universitas Sumatera Utara

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 18, 2026
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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