Acetated Ringer's Solution Versus Saline in Patients With Septic Shock

Not Applicable

• Conditions: Septic Shock Hyperdynamic
• Interventions: Drug: Fluid resuscitation

• Registration Number: NCT04507672
• Lead Sponsor: Southeast University, China

Brief Summary

The primary aim of this trial is to compare the effect of acetated ringer's solution with that of saline for therapy on the incidence and development of major adverse renal events among septic shock patients. The investigators hypothesize that use of acetated ringer's solution for resuscitation among septic shock patients will reduce the incidence of major adverse kidney events.

Detailed Description

Normal saline and Ringer's solutions are the preferred crystalloid fluids administered in early septic shock. However, evidence have associated saline with hyperchloremia and secondary metabolic acidosis, and renal vasoconstriction, increased incidence of acute kidney injury (AKI) and mortality. The primary aim of this trial is to compare the effect of acetated ringer's solution with that of saline for therapy on the incidence and development of major adverse renal events among septic shock patients. The investigators hypothesize that use of acetated ringer's solution for resuscitation among septic shock patients will reduce the incidence of major adverse kidney events.

Study Timeline

• Study First Submitted: 2020-07-02
• Status Verified: 2020-08
• Study First Submitted QC: 2020-08-09
• Last Update Submitted: 2020-08-09
• Study First Posted: 2020-08-11
• Last Update Posted: 2020-08-11
• Study Start: 2020-09-01
• Primary Completion: 2023-10-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

Adult patients presenting to the ICU diagnosed as septic shock within 24 hours.

Exclusion Criteria

1. Pregnancy;
2. Likely requirement for immediate hemodialysis or renal replacement therapy;
3. Patients have already received fluids for more than 4 liters;
4. Patient in extremis or death deemed imminent and inevitable.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
saline group	Fluid resuscitation	Use saline for fluid resuscitation during the first 72 hours after enrollment
Acetated Ringer's solution group	Fluid resuscitation	Use acetated Ringer's solution for fluid resuscitation during the first 72 hours after enrollment

Primary Outcome Measures

Name	Time	Method
Incidence of major adverse renal events in 28 days	28 day	Incidence of major adverse renal events

Secondary Outcome Measures

Name	Time	Method
Incidence of kidney injury	28 day	Incidence of kidney injury
Serum creatinine（umol/L）	28 day	serum creatinine（umol/L）