Category
»
Primary study
Registry of Trials»Clinical Trials Information System
Year
»
2022
INTERVENTION: Product Name: DOBUTAMINE PANPHARMA 250 mg/20 ml, solution à diluer pour perfusion,Product Code: PRD916431,Pharmaceutical Form: SOLUTION FOR INFUSION,Other descriptive name: ,Strength: Dobutamine 250mg / 20mL,Product Name: BEVITINE 100 mg/2 ml, solution injectable en ampoule,Product Code: PRD943785,Pharmaceutical Form: SOLUTION FOR INJECTION,Other descriptive name: ,Strength: Thiamine Hydrochloride 104mg,Product Name: LAROSCORBINE 1 g/5 ml, solution injectable I.V. en ampoule,Product Code: PRD462479,Pharmaceutical Form: SOLUTION FOR INJECTION,Other descriptive name: ,Strength: Ascorbic Acid 1g / 5mL,Product Name: NORADRENALINE (TARTRATE) AGUETTANT 2 mg/ml (SANS SULFITES), solution à diluer pour perfusion,Product Code: PRD588544,Pharmaceutical Form: SOLUTION FOR INFUSION,Other descriptive name: ,Strength: Noradrenaline Tartrate 2mg,Product Name: ADRENALINE AGUETTANT 1 mg/ml SANS SULFITE, solution injectable,Product Code: PRD549153,Pharmaceutical Form: SOLUTION FOR INJECTION,Other descriptive name: ,Strength: Epinephrine 1mg CONDITION: cardiac arrest Therapeutic area: Diseases [C] ‐ Cardiovascular Diseases [C14] PRIMARY OUTCOME: Main Objective:Our main objective is to assess the efficacy of IV high‐dose vit‐C to reduce the need for vasopressor within the first 3 days in patients who suffered from an OHCA with a post‐CA shock. Primary end point(s):Cumulative incidence of weaning from vasopressors at day 3 after OHCA. Secondary Objective:Compare between two groups the hospital mortality related to post‐CA shock within the first 7 day after OHCA,Compare between two groups the survival with good neurological outcome at day 28 after OHCA.,Compare between two groups the maximal dose of catecholamin infusion within the first 3 day after OHCA.,Compare between two groups organ failure within the first 3 days after OHCA.,Compare between two groups arterial lactate level within the first 3 days after OHCA SECONDARY OUTCOME: Secondary end point(s):Cumulative incidence of death by refractory shock within 7 days after OHCA. Secondary end point(s):The delta SOFA (sepsis‐related organ failure assessment score) is defined as the difference between SOFA admission and SOFA at 72 hours after OHCA. Death within 72 hours will be counted as the maximum SOFA score (i.e. 24 points). Secondary end point(s):The lower arterial lactate level at day 3 after OHCA. Secondary end point(s):The maximal vasopressors infusion dose within 3 days after OHCA. Secondary end point(s):the neurological outcome at day 28 after OHCA, assessed using the mRS (favorable neurological outcome will be considered if mRS range from 0 to 3; Unfavorable neurological outcome will be considered if mRS range from 4 to 6). INCLUSION CRITERIA: patients still comatose (Glasgow coma scale < 8),an OHCA of presumed cardiac origin with ROSC < 60 min,treated with a norepinephrin or an epinephrin continuous infusion = 0.2µg/kg/h, within 4 hours after OHCA, during at least 30 min/h to maintain mean arterial pressure (MAP) = 65 mmHg.
Epistemonikos ID: 1a8b5d636847a405c1617204f160582575064d4c
First added on: Aug 26, 2024