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Evaluation of the effect of intravenous lidocaine on the systemic inflammatory response associated with cardiopulmonary bypass in patients undergoing elective valvular and coronary cardiac surgery: A randomized double-blind clinical trial.

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-523534-11-00
Enrollment
90
Registered
2025-11-19
Start date
2025-12-15
Completion date
Unknown
Last updated
2025-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

at risk of systemic inflammatory response and related postoperative complications., Patients undergoing elective cardiac valve surgery and/or coronary artery bypass grafting with cardiopulmonary bypass

Brief summary

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.

Detailed description

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., 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., ICU Length of Stay: Total duration of the patient’s admission in the Intensive Care Unit, expressed in days, from admission to ICU discharge., One-Month Postoperative Mortality: Denotes whether the patient succumbed to any cause within the first 30 days following the date of surgery., 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., 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.

Interventions

Sponsors

Hospital San Pedro
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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., 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., ICU Length of Stay: Total duration of the patient’s admission in the Intensive Care Unit, expressed in days, from admission to ICU discharge., One-Month Postoperative Mortality: Denotes whether the patient succumbed to any cause within the first 30 days following the

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026