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Clinical Trials/NCT04507672
NCT04507672
Unknown
Not Applicable

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

Southeast University, China0 sites2,000 target enrollmentSeptember 1, 2020

Overview

Phase
Not Applicable
Intervention
Fluid resuscitation
Conditions
Septic Shock Hyperdynamic
Sponsor
Southeast University, China
Enrollment
2000
Primary Endpoint
Incidence of major adverse renal events in 28 days
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2020
End Date
December 1, 2023
Last Updated
5 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Southeast University, China
Responsible Party
Principal Investigator
Principal Investigator

Jingyuan,Xu

Zhongda Hospital,Southeast University, China

Southeast University, China

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

saline group

Use saline for fluid resuscitation during the first 72 hours after enrollment

Intervention: Fluid resuscitation

Acetated Ringer's solution group

Use acetated Ringer's solution for fluid resuscitation during the first 72 hours after enrollment

Intervention: Fluid resuscitation

Outcomes

Primary Outcomes

Incidence of major adverse renal events in 28 days

Time Frame: 28 day

Incidence of major adverse renal events

Secondary Outcomes

  • Incidence of kidney injury(28 day)
  • Serum creatinine(umol/L)(28 day)

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