Study SOLACE SEPSIS

NCT ID: NCT06634069

Last Updated: 2025-04-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-24
• Study Completion Date: 2027-10-31

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 1

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

Group Type: EXPERIMENTAL

Sodium Lactate

Intervention Type: DRUG

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

Group 2

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

Group Type: ACTIVE_COMPARATOR

3% NaCl

Intervention Type: DRUG

active compartor 3% NaCl

Interventions

Sodium Lactate

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

Intervention Type: DRUG

3% NaCl

active compartor 3% NaCl

Intervention Type: DRUG

Other Intervention Names

0.5M natrii lactatis

Eligibility Criteria

Inclusion Criteria

• Subjects will be eligible for the trial if they meet all of the following criteria:

1. Age criteria: 18 - 90 years

2. Septic shock - Sepsis 3 criteria :

1. acute change in total SOFA score ≥ 2 due to infection

2. use of vasopressor drug to maintain target mean arterial pressure ≥ 65 mmHg

3. blood lactate level ≥ 2 mmol/L within last 24 hours

3. Likely need for fluid resuscitation

1. 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

2. 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%

4. Signed the relevant informed consent form

Exclusion Criteria

• Subjects will not be eligible for the trial if they meet any of the following criteria:

1. Poor transthoracic echo windows

2. Actual body weight > 160 kg

3. Hypernatremia: [Na] > 150 mEq/L

4. Cardiac tamponade

5. Uncorrected severe valvular heart disease or life-threatening arrhythmia

6. Moribund patients likely to die before the study protocol is completed

7. Patients with absolute indication for immediate acute hemodialysis/hemofiltration (within 2 hrs) based on pH < 7.0, K > 7.0mmol/L

8. Severe liver dysfunction defined by total serum bilirubin > 120 umol/l

9. Pregnancy and lactation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Pilsen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital Pilsen

Pilsen, Czech Republic, Czechia

Site Status: RECRUITING

Countries

Czechia

Central Contacts

Miroslav Kříž, MD

Role: CONTACT

krizm@fnplzen.cz

+420732850912

Marek Nalos, MD

Role: CONTACT

marek.nalos@gmail.com

Facility Contacts

Miroslav Kříž, MD

Role: primary

krizm@fnplzen.cz

+420 732 850 912

Marek Nalos

Role: backup

mareknalos@gmail.com

Other Identifiers

EU CTR: 2024-517927-37-00

Identifier Type: -

Identifier Source: org_study_id