Low-chlorine Vs High-chlorine Crystalloids in Septic Shock Adults

Study Overview
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Brief Summary
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Fluid resuscitation is an important treatment in septic shock patients, however whether crystalloid composition affects septic shock patients outcomes remains unclear. According to previous studies, low-chlorine crystalloids could significantly reduce the incidence of kidney injury and 30-day mortality compared with high-chlorine crystalloids in critically ill adults. Therefore, we hypothesized that the use of low-chlorine crystalloids would result in a lower incidence of major adverse kidney events within 30 days (MAKE 30: overall incidence of death, new renal-replacement therapy, and persistent renal dysfunction) than high-chlorine crystalloids in septic shock adults.

Official Title
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Effects of Low-chlorine Vs High-chlorine Crystalloid Solutions in Septic Shock Adults

Conditions
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Septic Shock

Intervention / Treatment
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* Drug: Sodium Bicarbonate Ringer's Injection
* Drug: 0.9% Sodium Chloride Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years old <age ≤ 85 years old; Diagnosis of septic shock within 24 hours (sepsis 3.0); Needing fluid resuscitation judged by clinicians; The patient or the patient's legally acceptable representative signs the informed consent (signs within 24h of enrollment) Exclusion Criteria: Pregnant or lactating period; Renal replacement therapy has been received or expected to receive within 6 hours; Those who were previously enrolled in the study; Estimated death within 24 hours; Other situations that not suitable for enrollment judged by researchers.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Prospective cluster-randomized, multiple-crossover trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sodium Bicarbonate Ringer's Injection<br>administration route and dosage：Intravenous infusion, 500 1000 ml/time. The dosage can be increased or decreased according to the age, weight and symptoms. rate: according to the the routine rate of fluid resuscitation of septic shock in the ICUs of Zhongda Hospital, School of Medicine, Southeast University. | Drug: Sodium Bicarbonate Ringer's Injection<br>* For each month of the trial, participating ICUs were assigned to use either Sodium Bicarbonate Ringer's Injection or 0.9% Saline for any intravenous administration of isotonic crystalloid. ICUs were randomly assigned to use Sodium Bicarbonate Ringer's Injection during even-numbered months and 0.9% Saline during odd-numbered months, or vice versa.<br>|
| Active Comparator: 0.9% Sodium Chloride Injection<br>administration route and dosage：Intravenous infusion, 500 1000 ml/time. The dosage can be increased or decreased according to the age, weight and symptoms. rate: according to the the routine rate of fluid resuscitation of septic shock in the ICUs of Zhongda Hospital, School of Medicine, Southeast University. | Drug: 0.9% Sodium Chloride Injection<br>* For each month of the trial, participating ICUs were assigned to use either Sodium Bicarbonate Ringer's Injection or 0.9% Saline for any intravenous administration of isotonic crystalloid. ICUs were randomly assigned to use Sodium Bicarbonate Ringer's Injection during even-numbered months and 0.9% Saline during odd-numbered months, or vice versa.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the composite of death and new receipt of renal-replacement therapy MAKE30 | overall incidence of death, new renal-replacement therapy, and persistent renal dysfunction within 30 days | up to 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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crystalloids, septic shock, MAKE30