Early Co-Administration of 30 mL/kg Crystalloid Fluid and Norepinephrine for Preventing Acute Kidney Injury in Septic Shock: A Pretest-Posttest Clinical Study
| Registry | NCT07418541 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 100 (Estimated) |
| Sponsor | Universitas Sumatera Utara (Other) |
| Conditions | Septic Shock, Acute Kidney Injury |
| Interventions | Norepinephrine, Crystalloid Fluid Resuscitation (Drug, other) |
| Dates | start 2026-04-23 (estimated), primary completion 2026-12-01 (estimated), completion 2026-12-01 (estimated), first posted 2026-02-18, last updated 2026-02-18 |
Related Papers Related Patents Related Grants Related Experts
All trials for Septic Shock All trials for Acute Kidney Injury All trials of Norepinephrine All trials of Crystalloid Fluid Resuscitation
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Early Fluid Resuscitation Plus Norepinephrine | Experimental | Drug: Norepinephrine; Other: Crystalloid Fluid Resuscitation | 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. |
Sex: All, ages: 18 Years to any
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.