Perioperative Lidocaine for Lung Protection in Infants Undergoing Cardiac Surgery (NCT07499154) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Perioperative Lidocaine for Lung Protection in Infants Undergoing Cardiac Surgery
China320 participantsStarted 2026-04-01
Plain-language summary
Cardiopulmonary bypass-associated pulmonary injury is a common complication after infant cardiac surgery and may contribute to impaired oxygenation, prolonged mechanical ventilation, and longer intensive care stay. Lidocaine has anti-inflammatory and membrane-stabilizing properties and may attenuate perioperative lung injury. This investigator-initiated, randomized, placebo-controlled, double-blind trial will evaluate whether perioperative intravenous lidocaine reduces postoperative pulmonary injury in infants undergoing corrective non-palliative congenital cardiac surgery with cardiopulmonary bypass.
Who can participate
Age range
12 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Infants aged 0 to 12 months.
. Congenital heart disease requiring corrective, non-palliative cardiac surgery with cardiopulmonary bypass.
. American Society of Anesthesiologists (ASA) physical status I to III.
. Written informed consent provided by parent(s) or legal guardian(s).
Exclusion criteria
. Multiple malformations, chromosomal abnormalities, or immunodeficiency.
. Known or suspected allergy to lidocaine.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Acute Lung Injury Score within 72 hours after surgery
Timeframe: Assessed at 0, 12, 24, 36, 48, 60, and 72 hours after surgery
Trial details
NCT IDNCT07499154
SponsorThe Children's Hospital of Zhejiang University School of Medicine