NCT04365010

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Southeast University, China · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2020-05-01
• Primary completion: 2021-09-01
• Completion: 2021-12-01
• First posted: 2020-04-28
• Last updated: 2020-04-28