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

NCT07418541 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-02-18

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Universitas Sumatera Utara

    lead OTHER

Principal Investigators

  • Irfan Julio Nasution, MD · Universitas Sumatera Utara

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-23
Primary Completion
2026-12-31
Completion
2026-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07418541 on ClinicalTrials.gov