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

Phase 4

• Conditions: Septic Shock
• Interventions: Drug: Sodium Bicarbonate Ringer's Injection; Drug: 0.9% Sodium Chloride Injection

• Registration Number: NCT04365010
• Lead Sponsor: Southeast University, China

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-04
• Study First Submitted: 2020-04-24
• Study First Submitted QC: 2020-04-27
• Last Update Submitted: 2020-04-27
• Study First Posted: 2020-04-28
• Last Update Posted: 2020-04-28
• Study Start: 2020-05
• Primary Completion: 2021-09
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. 18 years old <age ≤ 85 years old;
2. Diagnosis of septic shock within 24 hours (sepsis 3.0);
3. Needing fluid resuscitation judged by clinicians;
4. The patient or the patient's legally acceptable representative signs the informed consent (signs within 24h of enrollment)

Exclusion Criteria

1. Pregnant or lactating period;
2. Renal replacement therapy has been received or expected to receive within 6 hours;
3. Those who were previously enrolled in the study;
4. Estimated death within 24 hours;
5. Other situations that not suitable for enrollment judged by researchers.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sodium Bicarbonate Ringer's Injection	Sodium Bicarbonate Ringer's Injection	1. administration route and dosage：Intravenous infusion, 500\~1000 ml/time. The dosage can be increased or decreased according to the age, weight and symptoms. 2. rate: according to the the routine rate of fluid resuscitation of septic shock in the ICUs of Zhongda Hospital, School of Medicine, Southeast University.
0.9% Sodium Chloride Injection	0.9% Sodium Chloride Injection	1. administration route and dosage：Intravenous infusion, 500\~1000 ml/time. The dosage can be increased or decreased according to the age, weight and symptoms. 2. rate: according to the the routine rate of fluid resuscitation of septic shock in the ICUs of Zhongda Hospital, School of Medicine, Southeast University.

Primary Outcome Measures

Name	Time	Method
the composite of death and new receipt of renal-replacement therapy MAKE30	up to 30 days	overall incidence of death, new renal-replacement therapy, and persistent renal dysfunction within 30 days