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.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Hospital San Pedro

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Trial duration

15 Dec 2025 → ongoing

Decision date (initial)

2025-11-19

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy

To evaluate whether intravenous administration of lidocaine reduces blood interleukin-6 (IL-6) levels at 6 hours after the end of surgery in patients undergoing elective cardiac valve and/or coronary artery bypass surgery with cardiopulmonary bypass.

Secondary objectives 7

1. To evaluate the temporal trajectory of inflammatory and myocardial injury biomarkers: Compare levels of interleukin-6 (IL-6), tumour necrosis factor-alpha (TNF-α), C-reactive protein (CRP), and troponin T (TnT) between the Lidocaine Group and the Placebo Group at predefined sampling time points (prior to anaesthetic induction, at the initiation of cardiopulmonary bypass, at the end of surgery, and at 6 and 24 hours postoperatively).
2. To determine the impact of lidocaine on postoperative complications associated with the systemic inflammatory response: Assess whether intraoperative intravenous administration of lidocaine reduces the incidence of the following complications during admission to the Intensive Care Unit (ICU).: Acute kidney injury (AKI). Infection and sepsis. Haemorrhage requiring transfusion of blood products. Multiple organ dysfunction (MOD). Vasoplegia requiring vasopressor support. Respiratory dysfunction. Neurological dysfunction.
3. To compare one-month postoperative mortality: Determine whether there are differences in all-cause mortality between the Lidocaine Group and the Placebo Group during the first 30 days after surgery.
4. To evaluate ICU length of stay: Compare total duration of ICU admission between the Lidocaine Group and the Placebo Group.
5. To analyse the modulatory effect of lidocaine in specific subgroups: Assess whether the anti-inflammatory and immunomodulatory effects of lidocaine differ between patients undergoing coronary artery bypass surgery and those undergoing valvular replacement or repair, evaluating both the primary and secondary outcomes in these subgroups.
6. To analyse the incidence of arrhythmias after aortic declamping: Determine whether lidocaine reduces the incidence of ventricular fibrillation and the need for defibrillation at the time of aortic declamping.
7. To compare postoperative pain: Evaluate whether there are differences in the number of rescue analgesia interventions and the total opioid dose required between the Lidocaine Group and the Placebo Group during the first 48 hours postoperatively.

Conditions and MedDRA coding

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

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. Patients must meet ALL of the following criteria to be included in the study: 1. Age > 18 years. 2. Scheduled (elective) surgery. 3. Valvular and/or coronary surgery (repair or replacement). 4. Use of cardiopulmonary bypass. 5. Provision of informed consent, after receiving adequate information about the study.

Exclusion criteria 1

1. Patients presenting ANY of the following criteria will not be eligible to participate in the study: 1. Chronic treatment with systemic corticosteroids within the 90 days prior to surgery. 2. Acute coronary syndrome within the last 10 days. 3. Hepatic failure Child-Pugh C. 4. Severe renal impairment (glomerular filtration rate < 30 mL/min). 5. Use of cytokine filter during cardiopulmonary bypass. 6. Active infection requiring systemic antibiotic treatment, including endocarditis during the hospital admission prior to surgery. 7. Pregnancy or breastfeeding. 8. Known allergy to lidocaine or any amide-type local anaesthetic. 9. Medical or surgical history which, in the investigator’s opinion, precludes participation in the study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 6

1. 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.
2. 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.
3. ICU Length of Stay: Total duration of the patient’s admission in the Intensive Care Unit, expressed in days, from admission to ICU discharge.
4. One-Month Postoperative Mortality: Denotes whether the patient succumbed to any cause within the first 30 days following the date of surgery.
5. 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.
6. 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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Hospital San Pedro

Sponsor organisation

Hospital San Pedro

Address

Calle Piqueras 98

City

Logrono

Postcode

26006

Country

Spain

Scientific contact point

Organisation

Hospital San Pedro

Contact name

Ana Fernández Martínez

Public contact point

Organisation

Hospital San Pedro

Contact name

Ana Fernández Martínez

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications