NCT06634069

Study SOLACE SEPSIS

A Pilot, Randomized, Double-Blinded, Controlled Study of Hemodynamic and Acid Base Effects of 0.5M Sodium Lactate and 3% Saline Solutions in Septic Shock Patients

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University Hospital Pilsen · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

A Pilot, Randomized, Double-Blinded, Controlled Study of Hemodynamic and Acid Base Effects of 0.5M Sodium Lactate and 3% Saline Solutions in Septic Shock Patients

Detailed description

This study investigates two resuscitation fluids that are being used off label for the treatment of patients suffering from septic shock and also in patients with intracranial hypertension in intensive care.

Conditions

• Septic Shock
• Intracranial Hypertension

Interventions

Type	Name	Description
DRUG	Sodium Lactate	0.5M HSL (containing 504mM of sodium and lactate)
DRUG	3% NaCl	active compartor 3% NaCl

Timeline

• Start date: 2024-11-24
• Primary completion: 2027-10-31
• Completion: 2027-10-31
• First posted: 2024-10-09
• Last updated: 2026-04-14

Locations

1 site across 1 country: Czechia

Regulatory

• FDA-regulated drug study