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

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

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.

Study Overview

• Status: Unknown
• Conditions: Septic Shock
• Intervention / Treatment: Drug: Sodium Bicarbonate Ringer's Injection; Drug: 0.9% Sodium Chloride Injection

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Haibo Qiu, MD, PhD; Phone Number: 0086-13951965301; Email: haiboq2000@163.com
• Study Contact Backup: Name: Jianfeng Xie, MD, PhD; Phone Number: 0086-13770332331; Email: xie820405@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sodium Bicarbonate Ringer's Injection; 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; 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.
Active Comparator: 0.9% Sodium Chloride Injection; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Southeast University, China

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2020
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: April 24, 2020
• First Submitted That Met QC Criteria: April 27, 2020
• First Posted (Actual): April 28, 2020

Study Record Updates

• Last Update Posted (Actual): April 28, 2020
• Last Update Submitted That Met QC Criteria: April 27, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: crystalloids, septic shock, MAKE30
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Shock, Septic; Shock
• Other Study ID Numbers: RIN013-C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No