Acetate Ringer's solution versus 0.9% saline for septic patients: study protocol for a multi-center parallel...

Area of Science:

• Critical care medicine
• Nephrology
• Sepsis research

Background:

• Previous studies show mixed results on saline vs. balanced crystalloids in critical illness, with a noted difference in sepsis subgroups.
• Acute kidney injury (AKI) severity and total fluid infusion volumes are hypothesized to influence renal outcomes.
• ClinicalTrials.gov registration: NCT03685214.

Purpose of the Study:

• To compare the effects of saline and balanced crystalloid solutions specifically in adult patients with sepsis/septic shock.
• To investigate the relationship between baseline renal function, infusion volumes, and kidney outcomes in septic patients receiving different fluid types.

Main Methods:

• Pragmatic, multi-center parallel controlled trial involving 312 sepsis/septic shock patients in the ICU.
• Patients randomized to either acetate Ringer's solution or saline.
• Exclusion criteria: end-stage renal disease (ESRD) or pre-existing need for renal replacement therapy (RRT).
• Primary outcome: Major Adverse Kidney Events within 28 days (MAKE28); Secondary outcomes: mortality, organ support duration, and length of stay.

Main Results:

• Study is ongoing; results are not yet available.
• Analysis will stratify patients by sepsis severity, baseline renal function, and intravenous fluid volumes.

Conclusions:

• This study aims to be the first to provide robust data on fluid choice in sepsis, considering renal function and volume.
• Findings are expected to clarify optimal fluid resuscitation strategies for septic patients, particularly regarding renal protection.