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

NCT04365010 | Unknown Phase 4

• 1 other identifier: RIN013-C
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Keywords

crystalloids, septic shock, MAKE30

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Sodium Bicarbonate Ringer's Injection

EXPERIMENTAL

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.

Drug: Sodium Bicarbonate Ringer's Injection

0.9% Sodium Chloride Injection

ACTIVE COMPARATOR

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.

Drug: 0.9% Sodium Chloride Injection

Interventions

Sodium Bicarbonate Ringer's Injection 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.

Sodium Bicarbonate Ringer's Injection

0.9% Sodium Chloride Injection 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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Southeast University, China: lead

MeSH Terms

Conditions

Shock, Septic

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Haibo Qiu, MD, PhD

CONTACT

0086-13951965301; haiboq2000@163.com

Jianfeng Xie, MD, PhD

CONTACT

0086-13770332331; xie820405@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D

Model Details: Prospective cluster-randomized, multiple-crossover trial

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: April 28, 2020
• Study Start: May 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 28, 2020

Record last verified: 2020-04