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

NCT ID: NCT04365010

Last Updated: 2020-04-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-31
• Study Completion Date: 2021-12-31

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.

Conditions

Septic Shock

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Sodium Bicarbonate Ringer's Injection

Intervention Type: DRUG

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.

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.

Group Type: ACTIVE_COMPARATOR

0.9% Sodium Chloride Injection

Intervention Type: DRUG

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.

Interventions

Sodium Bicarbonate Ringer's Injection

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.

Intervention Type: DRUG

0.9% Sodium Chloride Injection

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Southeast University, China

OTHER

Sponsor Role: lead

Responsible Party

Jianfeng Xie

Ph.D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Haibo Qiu, MD, PhD

Role: CONTACT

haiboq2000@163.com

0086-13951965301

Jianfeng Xie, MD, PhD

Role: CONTACT

xie820405@126.com

0086-13770332331

Other Identifiers

RIN013-C

Identifier Type: -

Identifier Source: org_study_id