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

Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04365010
• Other study ID #: RIN013-C
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: May 2020
• Est. completion date: December 2021

Study information

• Verified date: April 2020
• Source: Southeast University, China
• Contact: Haibo Qiu, MD, PhD
• Phone: 0086-13951965301
• Email: haiboq2000[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Southeast University, China

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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