Study SOLACE SEPSIS

NCT06634069 | Recruiting Phase 2 FDA Drug

• 1 other identifier: EU CTR: 2024-517927-37-00
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Septic Shock; Intracranial Hypertension

Keywords

intracranial hypertension; septic shock

Outcome Measures

Primary Outcomes (1)

• haemodynamic effects

  SV is the amount of blood that leaves the left ventricle with every beat cycle and is calculated by measuring the Doppler flow in the aortic valve. Unit: ml

  at time of start of infusion, at 30 minutes and at 60 minutes from the start of the respective fluid bolus

Secondary Outcomes (3)

• acid-base effect

  at time of start of infusion, at 30 minutes and at 60 minutes from the start of the respective fluid bolus

• anti-inflammatory effect

  parameters measured within the last 24 hours prior to start of infusion and within 24 hours after the study fluid infusion.

• Safety - Incidence of adverse events and reactions

  30 days after intervention

Study Arms (2)

Group 1

EXPERIMENTAL

Patients suffering from septic shock who require fluid resuscitation get 0.5M HSL (containing 504mM of sodium and lactate)

Drug: Sodium Lactate

Group 2

ACTIVE COMPARATOR

Patients suffering from septic shock who require fluid resuscitation get 3% NaCl (containing 513mM of sodium and chloride)

Drug: 3% NaCl

Interventions

Sodium Lactate DRUG

0.5M HSL (containing 504mM of sodium and lactate)

Also known as: 0.5M natrii lactatis

Group 1

3% NaCl DRUG

active compartor 3% NaCl

Group 2

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects will be eligible for the trial if they meet all of the following criteria:
• Age criteria: 18 - 90 years
• Septic shock - Sepsis 3 criteria :
• acute change in total SOFA score ≥ 2 due to infection
• use of vasopressor drug to maintain target mean arterial pressure ≥ 65 mmHg
• blood lactate level ≥ 2 mmol/L within last 24 hours
• Likely need for fluid resuscitation
• poor peripheral perfusion as evidenced by 2 out of 4: i. peripheral cyanosis with delayed capillary refill ≥ 3 seconds ii. low urinary output (\< 0.5 ml/kg/hour for at least 6 hours) iii. central venous O2 saturation \< 70% iv. clouded sensorium/poor mentation
• dynamic assessment of preload responsiveness as evidenced by 1 out of 3: i. positive passive leg raising test ii. pulse pressure variation and / or stroke volume variation2, both \> 12% iii. distensibility index of inferior vena caval diameter \> 12%
• Signed the relevant informed consent form

You may not qualify if:

• Subjects will not be eligible for the trial if they meet any of the following criteria:
• Poor transthoracic echo windows
• Actual body weight \> 160 kg
• Hypernatremia: \[Na\] \> 150 mEq/L
• Cardiac tamponade
• Uncorrected severe valvular heart disease or life-threatening arrhythmia
• Moribund patients likely to die before the study protocol is completed
• Patients with absolute indication for immediate acute hemodialysis/hemofiltration (within 2 hrs) based on pH \< 7.0, K \> 7.0mmol/L
• Severe liver dysfunction defined by total serum bilirubin \> 120 umol/l
• Pregnancy and lactation

Sponsors & Collaborators

• University Hospital Pilsen: lead

Study Sites (1)

University Hospital Pilsen

Pilsen, Czech Republic, 30100, Czechia

RECRUITING

MeSH Terms

Conditions

Shock, Septic; Intracranial Hypertension

Interventions

Sodium Lactate

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Lactates; Hydroxy Acids; Carboxylic Acids; Organic Chemicals

Central Study Contacts

Miroslav Kříž, MD

CONTACT

+420732850912; krizm@fnplzen.cz

Marek Nalos, MD

CONTACT

marek.nalos@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 9, 2024
• Study Start: November 24, 2024
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

CZ (1)