Lidocaine hydrochloride for Coronary artery disease|Cardiac valve disease

Inclusion criteria

• {"criterion_text":"- Age > 18 years.\n- Scheduled (elective) surgery.\n- Valvular and/or coronary surgery (repair or replacement).\n- Use of cardiopulmonary bypass.\n- Provision of informed consent, after receiving adequate information about the study."}

Exclusion criteria

• {"criterion_text":"- Chronic treatment with systemic corticosteroids within the 90 days prior to surgery.\n- Acute coronary syndrome within the last 10 days.\n- Hepatic failure Child-Pugh C.\n- Severe renal impairment (glomerular filtration rate < 30 mL/min).\n- Use of cytokine filter during cardiopulmonary bypass.\n- Active infection requiring systemic antibiotic treatment, including endocarditis during the hospital admission prior to surgery.\n- Pregnancy or breastfeeding.\n- Known allergy to lidocaine or any amide-type local anaesthetic.\n- Medical or surgical history which, in the investigator’s opinion, precludes participation in the study."}

Primary endpoints

• {"endpoint_text":"- Levels of Interleukin-6 (IL-6) in arterial blood at 6 hours postoperatively, measured by electrochemiluminescence immunoassay (ECLIA) using the laboratory’s validated platform according to its protocols.","definition_or_measurement_approach":"Measured in arterial blood at 6 hours postoperatively by electrochemiluminescence immunoassay (ECLIA) using the laboratory’s validated platform according to its protocols."}

Secondary endpoints

• {"endpoint_text":"- Levels of C-reactive protein (CRP), high-sensitivity Troponin T (TnT), and TNF-α in arterial blood at predefined time points: pre-anaesthesia, at the start of cardiopulmonary bypass, end of surgery, and 6 and 24 hours postoperatively. CRP will be measured by immunoturbidimetric assay, and TnT and TNF-α by electrochemiluminescence immunoassay (ECLIA) using the laboratory’s validated platforms and standard protocols.","definition_or_measurement_approach":"CRP: immunoturbidimetric assay; TnT and TNF-α: electrochemiluminescence immunoassay (ECLIA) on laboratory validated platforms at specified time points (pre-anaesthesia, start of CPB, end of surgery, 6h and 24h postoperatively)."}
• {"endpoint_text":"- Postoperative complications associated with systemic inflammatory response: Includes: Acute Kidney Injury, Infection/Sepsis, Multiple Organ Dysfunction, Haemorrhage requiring transfusion, Vasoplegia, Respiratory Dysfunction, and Neurological Dysfunction. Detailed definitions are provided in the study protocol.","definition_or_measurement_approach":"Composite of predefined postoperative complications; detailed definitions provided in study protocol (referenced in trial documents)."}
• {"endpoint_text":"- ICU Length of Stay: Total duration of the patient’s admission in the Intensive Care Unit, expressed in days, from admission to ICU discharge.","definition_or_measurement_approach":"Measured as total days from ICU admission to ICU discharge."}
• {"endpoint_text":"- One-Month Postoperative Mortality: Denotes whether the patient succumbed to any cause within the first 30 days following the date of surgery.","definition_or_measurement_approach":"All-cause mortality within 30 days after surgery."}
• {"endpoint_text":"- Post-Aortic Declamping Ventricular Fibrillation and Need for Defibrillation: Indicates the occurrence of ventricular fibrillation at the moment of aortic declamping and whether this arrhythmia required electrical defibrillation to restore sinus rhythm.","definition_or_measurement_approach":"Occurrence of ventricular fibrillation at aortic declamping and record of requirement for electrical defibrillation."}
• {"endpoint_text":"- Postoperative Pain: Assessed using two indicators: Number of analgesic rescues: Total additional doses of analgesics required beyond the scheduled regimen during the first 48 postoperative hours. Total opioid dose administered: Cumulative opioid dose in the first 48 hours postoperatively, expressed in milligrams of intravenous morphine equivalents.","definition_or_measurement_approach":"Number of additional rescue analgesic doses in first 48 hours and cumulative opioid dose (mg IV morphine equivalents) in first 48 hours."}

Spain

Earliest CTIS Part Ii Submission Date

26-08-2025

Latest Decision Or Authorization Date

19-11-2025

Processing Time Days

85

Number Of Sites

1

Number Of Participants

90

Primary sponsor

Full Name

Hospital San Pedro

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain