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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2023-12-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Septic Shock Hyperdynamic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Cluster-randomized, multiple-center trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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saline group

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

Group Type PLACEBO_COMPARATOR

Fluid resuscitation

Intervention Type DRUG

Use the choice of crystalloid for resuscitation during the first 72 hours after enrollment

Acetated Ringer's solution group

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

Group Type EXPERIMENTAL

Fluid resuscitation

Intervention Type DRUG

Use the choice of crystalloid for resuscitation during the first 72 hours after enrollment

Interventions

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Fluid resuscitation

Use the choice of crystalloid for resuscitation during the first 72 hours after enrollment

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No