[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564814":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":33,"locations":42,"responsibleParty":63,"collaborators":32,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":32,"studyType":79,"phases":80,"briefSummary":70,"conditions":82,"keywords":85,"overallStatus":44,"whyStopped":32,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"University Hospital Pilsen","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1","EXPERIMENTAL","Patients suffering from septic shock who require fluid resuscitation get 0.5M HSL (containing 504mM of sodium and lactate)",[13],"Drug: Sodium Lactate",{"label":15,"type":16,"description":17,"interventionNames":18},"Group 2","ACTIVE_COMPARATOR","Patients suffering from septic shock who require fluid resuscitation get 3% NaCl (containing 513mM of sodium and chloride)",[19],"Drug: 3% NaCl",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Sodium Lactate","0.5M HSL (containing 504mM of sodium and lactate)",[9],[27],"0.5M natrii lactatis",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"3% NaCl","active compartor 3% NaCl",[15],null,[34,39],{"name":35,"role":36,"phone":37,"phoneExt":32,"email":38},"Miroslav Kříž, MD","CONTACT","+420732850912","krizm@fnplzen.cz",{"name":40,"role":36,"phone":32,"phoneExt":32,"email":41},"Marek Nalos, MD","marek.nalos@gmail.com",[43],{"facility":5,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":32,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"RECRUITING","Pilsen","Czech Republic","30100","Czechia",{"type":50,"coordinates":51},"Point",[52,53],13.37759,49.74747,{"lat":53,"lon":52},[56,58,61],{"name":35,"role":36,"phone":57,"phoneExt":32,"email":38},"+420 732 850 912",{"name":59,"role":36,"phone":32,"phoneExt":32,"email":60},"Marek Nalos","mareknalos@gmail.com",{"name":35,"role":62,"phone":32,"phoneExt":32,"email":32},"PRINCIPAL_INVESTIGATOR",{"type":64,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100564814","phase-2-study-solace-sepsis-100564814",false,"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","MJIP1_0","Inclusion Criteria:\n\n* Subjects will be eligible for the trial if they meet all of the following criteria:\n\n  1. Age criteria: 18 - 90 years\n  2. Septic shock - Sepsis 3 criteria :\n\n     1. acute change in total SOFA score ≥ 2 due to infection\n     2. use of vasopressor drug to maintain target mean arterial pressure ≥ 65 mmHg\n     3. blood lactate level ≥ 2 mmol\u002FL within last 24 hours\n  3. Likely need for fluid resuscitation\n\n     1. poor peripheral perfusion as evidenced by 2 out of 4: i. peripheral cyanosis with delayed capillary refill ≥ 3 seconds ii. low urinary output (\\\u003C 0.5 ml\u002Fkg\u002Fhour for at least 6 hours) iii. central venous O2 saturation \\\u003C 70% iv. clouded sensorium\u002Fpoor mentation\n     2. dynamic assessment of preload responsiveness as evidenced by 1 out of 3: i. positive passive leg raising test ii. pulse pressure variation and \u002F or stroke volume variation2, both \\> 12% iii. distensibility index of inferior vena caval diameter \\> 12%\n  4. Signed the relevant informed consent form\n\nExclusion Criteria:\n\n* Subjects will not be eligible for the trial if they meet any of the following criteria:\n\n  1. Poor transthoracic echo windows\n  2. Actual body weight \\> 160 kg\n  3. Hypernatremia: \\[Na\\] \\> 150 mEq\u002FL\n  4. Cardiac tamponade\n  5. Uncorrected severe valvular heart disease or life-threatening arrhythmia\n  6. Moribund patients likely to die before the study protocol is completed\n  7. Patients with absolute indication for immediate acute hemodialysis\u002Fhemofiltration (within 2 hrs) based on pH \\\u003C 7.0, K \\> 7.0mmol\u002FL\n  8. Severe liver dysfunction defined by total serum bilirubin \\> 120 umol\u002Fl\n  9. Pregnancy and lactation","ALL","18 Years","90 Years",{"count":77,"type":78},40,"ESTIMATED","INTERVENTIONAL",[81],"PHASE2",[83,84],"Septic Shock","Intracranial Hypertension",[86,87],"intracranial hypertension","septic shock","2026-04-08",{"date":90,"type":91},"2026-04-14","ACTUAL",{"date":93,"type":91},"2024-11-24",{"date":95,"type":78},"2027-10-31",{"name":5,"class":6},1]