Acetated Ringer's Solution Versus Saline in Patients With Septic Shock

Study Overview
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Brief Summary
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The primary aim of this trial is to compare the effect of acetated ringer's solution with that of saline for therapy on the incidence and development of major adverse renal events among septic shock patients. The investigators hypothesize that use of acetated ringer's solution for resuscitation among septic shock patients will reduce the incidence of major adverse kidney events.

Detailed Description
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Normal saline and Ringer's solutions are the preferred crystalloid fluids administered in early septic shock. However, evidence have associated saline with hyperchloremia and secondary metabolic acidosis, and renal vasoconstriction, increased incidence of acute kidney injury (AKI) and mortality. The primary aim of this trial is to compare the effect of acetated ringer's solution with that of saline for therapy on the incidence and development of major adverse renal events among septic shock patients. The investigators hypothesize that use of acetated ringer's solution for resuscitation among septic shock patients will reduce the incidence of major adverse kidney events.

Official Title
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Acetated Ringer's Solution Versus Saline in Patients With Septic Shock

Conditions
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Septic Shock Hyperdynamic

Intervention / Treatment
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* Drug: Fluid resuscitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients presenting to the ICU diagnosed as septic shock within 24 hours. Exclusion Criteria: Pregnancy; Likely requirement for immediate hemodialysis or renal replacement therapy; Patients have already received fluids for more than 4 liters; Patient in extremis or death deemed imminent and inevitable.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Cluster-randomized, multiple-center trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: saline group<br>Use saline for fluid resuscitation during the first 72 hours after enrollment | Drug: Fluid resuscitation<br>* Use the choice of crystalloid for resuscitation during the first 72 hours after enrollment<br>|
| Experimental: Acetated Ringer's solution group<br>Use acetated Ringer's solution for fluid resuscitation during the first 72 hours after enrollment | Drug: Fluid resuscitation<br>* Use the choice of crystalloid for resuscitation during the first 72 hours after enrollment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of major adverse renal events in 28 days | Incidence of major adverse renal events | 28 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of kidney injury | Incidence of kidney injury | 28 day | 
| Serum creatinine（umol/L） | serum creatinine（umol/L） | 28 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crystalloid, Renal failure, Renal dysfunction