CALCIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, MAGNESIUM CHLORIDE for Coronary artery disease

Inclusion criteria

• {"criterion_text":"- Patients of legal age (>18 years) of both sexes."}
• {"criterion_text":"- Patients undergoing isolated myocardial revascularization surgery with extracorporeal circulation."}
• {"criterion_text":"- Patients providing the informed consent."}

Exclusion criteria

• {"criterion_text":"- Emergent surgery"}
• {"criterion_text":"- Acute coronary syndrome with or without ST elevation in the last 48 hours."}
• {"criterion_text":"- Patient who rejects blood products"}
• {"criterion_text":"- Patients with concomitant medical conditions that determine the need to use one or another cardioplegic solution; such as advanced chronic kidney disease, diabetes with poor glycemic control or significant preoperative anemia that requires hemodilution to be reduced as much as possible."}

Primary endpoints

• {"endpoint_text":"- Markers of myocardial damage: Peak levels of CK in U/L and ultrasensitive Troponin T in ng/L in blood. Basal levels will be determined daily during the first 5 postoperative days. The peak of CK and Troponin T will be recorded for each of the study subjects (usually it occurs during postoperative days 2 and 4).","definition_or_measurement_approach":"Basal levels determined daily during first 5 postoperative days; record peak CK (U/L) and ultrasensitive Troponin T (ng/L) for each subject (peak usually occurs on postoperative days 2 and 4)."}
• {"endpoint_text":"- Operative mortality. Operative mortality will be considered mortality in the following 30 days after the surgical intervention, or mortality during admission for the intervention (in patients whose admission exceeds 30 postoperative days).","definition_or_measurement_approach":"Mortality occurring within 30 days after surgery or during the admission for the intervention if length of stay exceeds 30 postoperative days."}

Secondary endpoints

• {"endpoint_text":"- Aortic clamping time (minutes)","definition_or_measurement_approach":"Duration of aortic cross-clamp measured in minutes."}
• {"endpoint_text":"- Extracorporeal circulation time (minutes)","definition_or_measurement_approach":"Duration of cardiopulmonary bypass (extracorporeal circulation) measured in minutes."}
• {"endpoint_text":"- Spontaneous recovery of the rhythm after aortic unclamping: it will be recorded during the intraoperative period if there is spontaneous recovery of the cardiac rhythm after removing the aortic clamp.","definition_or_measurement_approach":"Recorded intraoperatively if spontaneous recovery of native cardiac rhythm occurs after unclamping."}
• {"endpoint_text":"- Need for post-aortic unclamping defibrillation: it will be recorded if defibrillation is necessary to recover one's own heart rhythm.","definition_or_measurement_approach":"Recorded if defibrillation is required post-unclamping to restore rhythm."}
• {"endpoint_text":"- Need for inotropes for weaning from CPB: it will be recorded if the administration of inotropes is necessary for weaning from CPB. If yes, the type and maximum dose of inotrope required will be recorded.","definition_or_measurement_approach":"Recorded if inotropes required for weaning from cardiopulmonary bypass; type and maximum dose of inotrope documented."}
• {"endpoint_text":"- Maximum intraoperative blood glucose (in mmol/L).","definition_or_measurement_approach":"Maximum measured intraoperative blood glucose in mmol/L."}
• {"endpoint_text":"- Intraoperative insulin needs and during the 48 hours postoperatively.","definition_or_measurement_approach":"Insulin requirements recorded intraoperatively and during first 48 postoperative hours."}
• {"endpoint_text":"- Minimum intraoperative, postoperative and discharge hemoglobin (in g/L).","definition_or_measurement_approach":"Lowest hemoglobin measured intraoperatively, postoperatively, and at discharge in g/L."}
• {"endpoint_text":"- Maximum intraoperative lactate (in mmol/L),","definition_or_measurement_approach":"Maximum intraoperative lactate measured in mmol/L."}
• {"endpoint_text":"- Need for intraoperative and postoperative red blood cell transfusion.","definition_or_measurement_approach":"Recorded need for RBC transfusion intraoperatively and postoperatively."}
• {"endpoint_text":"- Inotrope need and duration during intra- and postoperative.","definition_or_measurement_approach":"Presence and duration of inotrope therapy recorded intra- and postoperatively."}
• {"endpoint_text":"- Need for mechanical circulatory assistance: need for circulatory support using a counterpulsation balloon or ECMO.","definition_or_measurement_approach":"Recorded requirement for mechanical circulatory support (intra- or postoperative) such as IABP or ECMO."}
• {"endpoint_text":"- Perioperative myocardial infarction according to the 5th universal definition.","definition_or_measurement_approach":"Perioperative MI adjudicated per 5th universal definition."}
• {"endpoint_text":"- Episodes of de novo atrial fibrillation.","definition_or_measurement_approach":"Recorded episodes of new-onset atrial fibrillation."}
• {"endpoint_text":"- Intubation hours.","definition_or_measurement_approach":"Duration of intubation in hours."}
• {"endpoint_text":"- Left ventricular function by echocardiography at discharge.","definition_or_measurement_approach":"LVEF measured by transthoracic echocardiography at discharge."}
• {"endpoint_text":"- Cardiac resonance (subgroup of patients): one pre-surgery and another 7-10 days after surgery with cine sequences, mapping and late enhancement.","definition_or_measurement_approach":"Cardiac MRI performed pre-surgery and 7-10 days post-surgery with cine, mapping and late gadolinium enhancement sequences (subgroup)."}
• {"endpoint_text":"- Days of admission to the ICU.","definition_or_measurement_approach":"Number of days in ICU."}
• {"endpoint_text":"- Total hospitalization days.","definition_or_measurement_approach":"Total length of hospital stay in days."}

Spain

Earliest CTIS Part Ii Submission Date

19-01-2024

Latest Decision Or Authorization Date

15-02-2024

Processing Time Days

27

Number Of Sites

1

Number Of Participants

286

Primary sponsor

Full Name

Fundacio Institut De Recerca De L Hospital De La Santa Creu I Sant Pau

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain