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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04507672

Enrollment

2000

Registered

2020-08-11

Start date

2020-09-01

Completion date

2023-12-01

Last updated

2020-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic Shock Hyperdynamic

Keywords

Crystalloid, Renal failure, Renal dysfunction

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.

Interventions

DRUGFluid resuscitation

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Cluster-randomized, multiple-center trial

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Incidence of major adverse renal events in 28 days	28 day	Incidence of major adverse renal events

Secondary

Measure	Time frame	Description
Incidence of kidney injury	28 day	Incidence of kidney injury
Serum creatinine（umol/L）	28 day	serum creatinine（umol/L）

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026