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

Southeast University, China

Status and phase: Unknown; Phase 4

Conditions: Septic Shock

Treatments: Drug: 0.9% Sodium Chloride Injection; Drug: Sodium Bicarbonate Ringer's Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04365010

RIN013-C

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Sodium Bicarbonate Ringer's Injection

Experimental group

Description:

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.

Treatment:

Drug: Sodium Bicarbonate Ringer's Injection

0.9% Sodium Chloride Injection

Active Comparator group

Description:

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.

Treatment:

Drug: 0.9% Sodium Chloride Injection