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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
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517927-37-00
Acronym
MJIP1.0
Enrollment
40
Registered
2024-11-11
Start date
2024-11-24
Completion date
Unknown
Last updated
2025-03-19

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

Conditions

Patients suffering from septic shock who require fluid resuscitation.

Brief summary

Change in cardiac stroke work (SW = SV x MAP) assessed by means of transthoracic echocardiography (SV) and a fluid filled arterial pressure transducer system (MAP) measured at time of start of infusion, at 30 minutes and at 60 minutes from the start of the respective fluid bolus (0.5M HSL or 3% NaCl). Monitored parameters:  SV (mL; start of infusion, 30 min and 60 min after start of infusion)  MAP (mmHg; start of infusion, 30 min and 60 min after start of infusion)

Detailed description

Comparison of laboratory values of arterial blood gases and electrolytes between study groups

Interventions

Sponsors

Fakultni Nemocnice Plzen
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change in cardiac stroke work (SW = SV x MAP) assessed by means of transthoracic echocardiography (SV) and a fluid filled arterial pressure transducer system (MAP) measured at time of start of infusion, at 30 minutes and at 60 minutes from the start of the respective fluid bolus (0.5M HSL or 3% NaCl). Monitored parameters:  SV (mL; start of infusion, 30 min and 60 min after start of infusion)  MAP (mmHg; start of infusion, 30 min and 60 min after start of infusion)

Secondary

MeasureTime frame
Comparison of laboratory values of arterial blood gases and electrolytes between study groups

Countries

Czechia

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026