Study SOLACE SEPSIS

Launched by UNIVERSITY HOSPITAL PILSEN · Oct 7, 2024

Keywords

ClinConnect Summary

The SOLACE SEPSIS trial is a research study looking at how two different solutions, sodium lactate and saline, affect patients who are experiencing septic shock. Septic shock is a serious condition that occurs when an infection leads to a dangerous drop in blood pressure and can cause organs to fail. This study aims to understand how these solutions can help improve blood flow and balance in the body during this critical time.

To participate in the trial, individuals must be between 18 and 90 years old and have been diagnosed with septic shock based on specific medical criteria. Participants should also need help with fluid resuscitation, which means they may require additional fluids to improve their circulation. The study is currently recruiting, and all participants will receive either sodium lactate or saline without knowing which one they are getting, to ensure fairness in results. Anyone interested in joining should talk to their healthcare provider to see if they meet the necessary requirements.

Gender

ALL

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