Septic Shock
Conditions
Keywords
crystalloids, septic shock, MAKE30
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.
Interventions
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.
DRUG0.9% 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.
Sponsors
Southeast University, China
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective cluster-randomized, multiple-crossover trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the composite of death and new receipt of renal-replacement therapy MAKE30 | up to 30 days | overall incidence of death, new renal-replacement therapy, and persistent renal dysfunction within 30 days |
Contacts
Primary ContactHaibo Qiu, MD, PhD
Backup ContactJianfeng Xie, MD, PhD
Outcome results
None listed