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

Southeast University, China

Status: Unknown

Conditions: Septic Shock Hyperdynamic

Treatments: Drug: Fluid resuscitation

Study type: Interventional

Funder types: Other

Identifiers

NCT04507672

2018ZDSYLL105-P01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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2,000 participants in 2 patient groups, including a placebo group

saline group

Placebo Comparator group

Description:

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

Treatment:

Drug: Fluid resuscitation

Acetated Ringer's solution group

Experimental group

Description:

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

Treatment:

Drug: Fluid resuscitation