Congenital Heart DiseasePhase 4PLICSNCT07499154
Perioperative Lidocaine for Lung Protection in Infants Undergoing Cardiac Surgery
A Phase 4 study testing Lidocaine %2 ampoule and Normal Saline (0.9% NaCl) in people with Congenital Heart Disease and Postoperative Pulmonary Complications, run by The Children's Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 12 months
- Conditions the study is for
- Congenital Heart Disease, Postoperative Pulmonary Complications, Acute Lung Injury
- What is being tested?
- Lidocaine %2 ampoule and Normal Saline (0.9% NaCl)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- Multiple malformations, chromosomal abnormalities, or immunodeficiency.
- Known or suspected allergy to lidocaine.
- Concomitant continuous infusion of another local anesthetic.
- Conditions associated with increased risk of lidocaine accumulation or toxicity, including severe conduction block or severe bradycardia.
- ASA physical status IV or higher.
- Severe malnutrition expected to substantially impair postoperative recovery.
Show all 11Show fewer
- Severe hepatic or renal dysfunction.
- Significant pre-existing pulmonary disease or markedly impaired preoperative pulmonary function.
- Central nervous system disorders that may increase susceptibility to lidocaine neurotoxicity, including epilepsy or prior central nervous system infection.
- Use of medications that may interact with lidocaine or constitute an exclusion, including class I or class III antiarrhythmic agents, cimetidine, or antiviral drugs, as determined by the clinical team.
- Current or recent participation in another interventional clinical trial in its active intervention phase.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310052
Qian Chen, MD, PhD, +86 13883350798, qian.chen@zju.edu.cn
About this study
Official title: Evaluation of the Effect of Perioperative Lidocaine Administration on Reducing Pulmonary Injury in Infants Following Cardiac Surgery: A Randomized, Placebo-Controlled, Double-Blind, Multi-center Superiority Trial.
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.
Read the detailed description
Infants undergoing cardiac surgery with cardiopulmonary bypass are at risk of postoperative pulmonary injury due to systemic inflammatory activation, ischemia-reperfusion injury, and disruption of the alveolar-capillary barrier. Intravenous lidocaine has been reported to exert anti-inflammatory, anti-arrhythmic, and potential organ-protective effects. However, evidence in infants undergoing cardiac surgery remains limited.
This randomized, double-blind, placebo-controlled superiority trial will enroll infants aged 0 to 12 months scheduled for corrective, non-palliative congenital cardiac surgery with cardiopulmonary bypass at a tertiary pediatric center. Participants will be randomized in a 1:1 ratio to receive either perioperative intravenous lidocaine or volume-matched normal saline placebo. The trial will assess postoperative pulmonary injury severity over the first 72 hours after surgery, together with respiratory, laboratory, echocardiographic, and safety outcomes until postoperative day 7 or at discharge.
- Being tested
- Lidocaine %2 ampoule, Normal Saline (0.9% NaCl)
- Keywords
- Lidocaine, Lung injury, Infant cardiac surgery, Cardiopulmonary bypass
- Medical subject headings
- Heart Defects, Congenital, Acute Lung Injury, Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine %2 ampouleDrug
Intravenous lidocaine hydrochloride 2%: loading dose 1.0 mg/kg administered over 20 minutes starting at the surgery, followed by continuous infusion at 1.0 mg/kg/hour for 24 hours. Dosing is based on standard body weight or actual body weight according to protocol-defined rules.
Normal Saline (0.9% NaCl)Drug
Volume-matched 0.9% normal saline placebo administered according to the same schedule as the lidocaine group.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine Group | Experimental | Participants receive intravenous lidocaine beginning at the surgery, with a loading infusion over 20 minutes followed by continuous infusion for 24 hours. Receives: Drug: Lidocaine %2 ampoule |
| Placebo Group | Placebo comparator | Participants receive volume-matched intravenous normal saline placebo beginning at the surgery, with the same administration schedule as the active intervention. Receives: Drug: Normal Saline (0.9% NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Lung Injury Score within 72 hours after surgery
Composite lung injury severity score ranging from 0 to 4, based on oxygenation index or oxygen saturation index, chest radiograph findings, positive en-expiratory pressure, and pulmonary compliance. Higher scores indicate more severe lung injury.
Measured: Assessed at 0, 12, 24, 36, 48, 60, and 72 hours after surgery
Secondary outcomes (24)
Arterial partial pressure of oxygen
Measured by arterial blood gas analysis, reported in mmHg.
Measured: 0, 12, 24, 36, 48, 60, and 72 hours after surgery
Arterial partial pressure of carbon dioxide
Measured by arterial blood gas analysis, reported in mmHg.
Measured: 0, 12, 24, 36, 48, 60, and 72 hours after surgery
Arterial oxygen saturation
Measured by arterial blood gas analysis, reported as percentage (%).
Measured: 0, 12, 24, 36, 48, 60, and 72 hours after surgery
Arterial lactate concentration
Measured by arterial blood gas analysis, reported in mmol/L.
Measured: 0, 12, 24, 36, 48, 60, and 72 hours after surgery
Duration of mechanical ventilation
Total duration of invasive mechanical ventilation, measured in hours, from postoperative admission to the intensive care unit until first successful extubation without the need for reintubation.
Measured: From postoperative ICU admission until successful discontinuation of invasive mechanical ventilation, assessed up to 72 hours after surgery.
PICU length of stay
Duration of stay in the pediatric intensive care unit, measured in days.
Measured: From postoperative admission to the pediatric intensive care unit until discharge from the pediatric intensive care unit, assessed up to 7 days after surgery.
Left ventricular ejection fraction (LVEF)
Left ventricular fractional shortening assessed by transthoracic echocardiography, reported as percentage (%).
Measured: Baseline, 24, 48, and 72 hours after surgery
Plasma lidocaine concentration
Plasma lidocaine concentration measured using the assay specified in the study laboratory manual, reported in ug/mL
Measured: 6, 12, 18, 24 hours after surgery
Incidence of postoperative pulmonary complications
Incidence of at least one postoperative pulmonary complication within 72 hours after surgery, defined as the occurrence of any of the following: atelectasis, pulmonary edema, pleural effusion, pneumothorax, or infectious pneumonia. Reported as the percentage of participants with at least one postoperative pulmonary complication.
Measured: Assessed within 72 hours after surgery
Prothrombin time (PT)
Measured in venous blood by routine clinical laboratory testing, reported in seconds.
Measured: Baseline, 24, 48, and 72 hours after surgery
Activated partial thromboplastin time (aPTT)
Measured in venous blood by routine clinical laboratory testing, reported in seconds.
Measured: Baseline, 24, 48, and 72 hours after surgery
Alanine aminotransferase (ALT)
Measured by routine clinical laboratory testing, reported in U/L.
Measured: Baseline, 24, 48, and 72 hours after surgery
Aspartate aminotransferase (AST)
Measured by routine clinical laboratory testing, reported in U/L.
Measured: Baseline, 24, 48, and 72 hours after surgery
Serum creatinine
Measured by routine clinical laboratory testing, reported in umol/L.
Measured: Baseline, 24, 48, and 72 hours after surgery
Blood urea nitrogen
Measured by routine clinical laboratory testing, reported in mmol/L.
Measured: Baseline, 24, 48, and 72 hours after surgery
Plasma soluble intercellular adhesion molecule-1 (sICAM-1) concentration
Measured using ELISA assay kit, reported in umol/L
Measured: Baseline, 24, 48, and 72 hours after surgery
Plasma surfactant protein D (SP-D) concentration
Measured using ELISA assay kit, reported in umol/L
Measured: Baseline, 24, 48, and 72 hours after surgery
Plasma soluble receptor for advanced glycation end products (sRAGE) concentration
Measured using ELISA assay kit, reported in umol/L
Measured: Baseline, 24, 48, and 72 hours after surgery
Plasma interleukin-1 beta (IL-1β) concentration
Measured using ELISA assay kit, reported in umol/L
Measured: Baseline, 24, 48, and 72 hours after surgery
Plasma angiopoietin-2 concentration
Measured using ELISA assay kit, reported in umol/L
Measured: Baseline, 24, 48, and 72 hours after surgery
Plasma double-stranded DNA (dsDNA) concentration
Measured using ELISA assay kit, reported in umol/L
Measured: Baseline, 24, 48, and 72 hours after surgery
Plasma high-mobility group box 1 (HMGB1) concentration
Measured using ELISA assay kit, reported in umol/L
Measured: Baseline, 24, 48, and 72 hours after surgery
Plasma neurofilament light chain (NFL) concentration
Measured using ELISA assay kit, reported in umol/L
Measured: Baseline, 24, 48, and 72 hours after surgery
Plasma S100B concentration
Measured using ELISA assay kit, reported in umol/L
Measured: Baseline, 24, 48, and 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by The Children's Hospital of Zhejiang University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio to receive either intravenous lidocaine or volume-matched normal saline placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07499154
- Sponsor's protocol ID
- 2026-IRB-0031-P-01
- Acronym
- PLICS
- Status last verified
- Mar 2026
- First submitted
- 12 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhang C, Foo I. Is intravenous lidocaine protective against myocardial ischaemia and reperfusion injury after cardiac surgery? Ann Med Surg (Lond). 2020 Sep 11;59:72-75. doi: 10.1016/j.amsu.2020.09.008. eCollection 2020 Nov.
PubMed 32994986Gregory AJ, Arora RC, Chatterjee S, Crisafi C, Morton-Bailey V, Rea A, Salenger R, Engelman DT, Grant MC; ERAS Cardiac Working Group. Enhanced Recovery After Surgery (ERAS) cardiac turnkey order set for perioperative pain management in cardiac surgery: Proceedings from the American Association for Thoracic Surgery (AATS) ERAS Conclave 2023. JTCVS Open. 2024 Sep 6;22:14-24. doi: 10.1016/j.xjon.2024.08.018. eCollection 2024 Dec.
PubMed 39780778Wang L, Wang M, Li S, Wu H, Shen Q, Zhang S, Fang L, Liu R. Nebulized lidocaine ameliorates allergic airway inflammation via downregulation of TLR2. Mol Immunol. 2018 May;97:94-100. doi: 10.1016/j.molimm.2018.03.010. Epub 2018 Mar 30.
PubMed 29609129Lee JM, Suh JK, Jeong JS, Cho SY, Kim DW. Antioxidant effect of lidocaine and procaine on reactive oxygen species-induced endothelial dysfunction in the rabbit abdominal aorta. Korean J Anesthesiol. 2010 Aug;59(2):104-10. doi: 10.4097/kjae.2010.59.2.104. Epub 2010 Aug 20.
PubMed 20740215Kavcic H, Jug U, Mavri J, Umek N. Antioxidant activity of lidocaine, bupivacaine, and ropivacaine in aqueous and lipophilic environments: an experimental and computational study. Front Chem. 2023 Jun 20;11:1208843. doi: 10.3389/fchem.2023.1208843. eCollection 2023.
PubMed 37408557Weibel S, Jelting Y, Pace NL, Helf A, Eberhart LH, Hahnenkamp K, Hollmann MW, Poepping DM, Schnabel A, Kranke P. Continuous intravenous perioperative lidocaine infusion for postoperative pain and recovery in adults. Cochrane Database Syst Rev. 2018 Jun 4;6(6):CD009642. doi: 10.1002/14651858.CD009642.pub3.
PubMed 29864216Simonato M, Padalino M, Vedovelli L, Carollo C, Sartori A, Vida V, Gregori D, Carnielli V, Cogo P. Effect of preoperative pulmonary hemodynamic and cardiopulmonary bypass on lung function in children with congenital heart disease. Eur J Pediatr. 2023 Jun;182(6):2549-2557. doi: 10.1007/s00431-023-04926-0. Epub 2023 Mar 18.
PubMed 36933017Fischer MO, Brotons F, Briant AR, Suehiro K, Gozdzik W, Sponholz C, Kirkeby-Garstad I, Joosten A, Nigro Neto C, Kunstyr J, Parienti JJ, Abou-Arab O, Ouattara A; VENICE study group. Postoperative Pulmonary Complications After Cardiac Surgery: The VENICE International Cohort Study. J Cardiothorac Vasc Anesth. 2022 Aug;36(8 Pt A):2344-2351. doi: 10.1053/j.jvca.2021.12.024. Epub 2021 Dec 25.
PubMed 35094928Jenke A, Yazdanyar M, Miyahara S, Chekhoeva A, Immohr MB, Kistner J, Boeken U, Lichtenberg A, Akhyari P. AdipoRon Attenuates Inflammation and Impairment of Cardiac Function Associated With Cardiopulmonary Bypass-Induced Systemic Inflammatory Response Syndrome. J Am Heart Assoc. 2021 Mar 16;10(6):e018097. doi: 10.1161/JAHA.120.018097. Epub 2021 Mar 5.
PubMed 33666100Sperotto F, Cogo P, Amigoni A, Pettenazzo A, Thiagarajan RR, Polito A. Extracorporeal Membrane Oxygenation Support for Failure to Wean From Cardiopulmonary Bypass After Pediatric Cardiac Surgery: Analysis of Extracorporeal Life Support Organization Registry Data. Crit Care Explor. 2020 Sep 15;2(9):e0183. doi: 10.1097/CCE.0000000000000183. eCollection 2020 Sep.
PubMed 32984825Cholette JM, Muszynski JA, Ibla JC, Emani S, Steiner ME, Vogel AM, Parker RI, Nellis ME, Bembea MM; Pediatric Critical Care Transfusion and Anemia EXpertise Initiative-Control/Avoidance of Bleeding (TAXI-CAB), in collaboration with the Pediatric Critical Care Blood Research Network (BloodNet), and the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network. Plasma and Platelet Transfusions Strategies in Neonates and Children Undergoing Cardiac Surgery With Cardiopulmonary Bypass or Neonates and Children Supported by Extracorporeal Membrane Oxygenation: From the Transfusion and Anemia EXpertise Initiative-Control/Avoidance of Bleeding. Pediatr Crit Care Med. 2022 Jan 1;23(13 Supple 1 1S):e25-e36. doi: 10.1097/PCC.0000000000002856.
PubMed 34989703
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Perioperative Lidocaine Administration on Reducing Pulmonary Injury in Infants Following Cardiac Surgery: A Randomized, Placebo-Controlled, Double-Blind, Multi-center Superiority Trial.
- ClinicalTrials.gov ID
- NCT07499154
- Acronym / sponsor ID
- PLICS / 2026-IRB-0031-P-01
- Keywords
- Lidocaine, Lung injury, Infant cardiac surgery, Cardiopulmonary bypass
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- The Children's Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Infants undergoing cardiac surgery with cardiopulmonary bypass are at risk of postoperative pulmonary injury due to systemic inflammatory activation, ischemia-reperfusion injury, and disruption of the alveolar-capillary barrier. Intravenous lidocaine has been reported to exert anti-inflammatory, anti-arrhythmic, and potential organ-protective effects. However, evidence in infants undergoing cardiac surgery remains limited.
This randomized, double-blind, placebo-controlled superiority trial will enroll infants aged 0 to 12 months scheduled for corrective, non-palliative congenital cardiac surgery with cardiopulmonary bypass at a tertiary pediatric center. Participants will be randomized in a 1:1 ratio to receive either perioperative intravenous lidocaine or volume-matched normal saline placebo. The trial will assess postoperative pulmonary injury severity over the first 72 hours after surgery, together with respiratory, laboratory, echocardiographic, and safety outcomes until postoperative day 7 or at discharge.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to receive either intravenous lidocaine or volume-matched normal saline placebo.
| Arm | Type | Receives |
|---|---|---|
| Lidocaine Group | Experimental | Drug: Lidocaine %2 ampouleParticipants receive intravenous lidocaine beginning at the surgery, with a loading infusion over 20 minutes followed by continuous infusion for 24 hours. |
| Placebo Group | Placebo comparator | Drug: Normal Saline (0.9% NaCl)Participants receive volume-matched intravenous normal saline placebo beginning at the surgery, with the same administration schedule as the active intervention. |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (11 listed)
- Multiple malformations, chromosomal abnormalities, or immunodeficiency.
- Known or suspected allergy to lidocaine.
- Concomitant continuous infusion of another local anesthetic.
- Conditions associated with increased risk of lidocaine accumulation or toxicity, including severe conduction block or severe bradycardia.
- ASA physical status IV or higher.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine %2 ampouleIntravenous lidocaine hydrochloride 2%: loading dose 1.0 mg/kg administered over 20 minutes starting at the surgery, followed by continuous infusion at 1.0 mg/kg/hour for 24 hours. Dosing is based on standard body weight or actual body weight according to protocol-defined rules. | Drug | Lidocaine Group |
| Normal Saline (0.9% NaCl)Volume-matched 0.9% normal saline placebo administered according to the same schedule as the lidocaine group. | Drug | Placebo Group |
Primary outcome
Acute Lung Injury Score within 72 hours after surgery
Time frame: Assessed at 0, 12, 24, 36, 48, 60, and 72 hours after surgery
Composite lung injury severity score ranging from 0 to 4, based on oxygenation index or oxygen saturation index, chest radiograph findings, positive en-expiratory pressure, and pulmonary compliance. Higher scores indicate more severe lung injury.
24 secondary outcomes
Arterial partial pressure of oxygen
Time frame: 0, 12, 24, 36, 48, 60, and 72 hours after surgery
Arterial partial pressure of carbon dioxide
Time frame: 0, 12, 24, 36, 48, 60, and 72 hours after surgery
Arterial oxygen saturation
Time frame: 0, 12, 24, 36, 48, 60, and 72 hours after surgery
Arterial lactate concentration
Time frame: 0, 12, 24, 36, 48, 60, and 72 hours after surgery
Duration of mechanical ventilation
Time frame: From postoperative ICU admission until successful discontinuation of invasive mechanical ventilation, assessed up to 72 hours after surgery.
PICU length of stay
Time frame: From postoperative admission to the pediatric intensive care unit until discharge from the pediatric intensive care unit, assessed up to 7 days after surgery.
Left ventricular ejection fraction (LVEF)
Time frame: Baseline, 24, 48, and 72 hours after surgery
Plasma lidocaine concentration
Time frame: 6, 12, 18, 24 hours after surgery
Incidence of postoperative pulmonary complications
Time frame: Assessed within 72 hours after surgery
Prothrombin time (PT)
Time frame: Baseline, 24, 48, and 72 hours after surgery
Activated partial thromboplastin time (aPTT)
Time frame: Baseline, 24, 48, and 72 hours after surgery
Alanine aminotransferase (ALT)
Time frame: Baseline, 24, 48, and 72 hours after surgery
Aspartate aminotransferase (AST)
Time frame: Baseline, 24, 48, and 72 hours after surgery
Serum creatinine
Time frame: Baseline, 24, 48, and 72 hours after surgery
Blood urea nitrogen
Time frame: Baseline, 24, 48, and 72 hours after surgery
Plasma soluble intercellular adhesion molecule-1 (sICAM-1) concentration
Time frame: Baseline, 24, 48, and 72 hours after surgery
Plasma surfactant protein D (SP-D) concentration
Time frame: Baseline, 24, 48, and 72 hours after surgery
Plasma soluble receptor for advanced glycation end products (sRAGE) concentration
Time frame: Baseline, 24, 48, and 72 hours after surgery
Plasma interleukin-1 beta (IL-1β) concentration
Time frame: Baseline, 24, 48, and 72 hours after surgery
Plasma angiopoietin-2 concentration
Time frame: Baseline, 24, 48, and 72 hours after surgery
Plasma double-stranded DNA (dsDNA) concentration
Time frame: Baseline, 24, 48, and 72 hours after surgery
Plasma high-mobility group box 1 (HMGB1) concentration
Time frame: Baseline, 24, 48, and 72 hours after surgery
Plasma neurofilament light chain (NFL) concentration
Time frame: Baseline, 24, 48, and 72 hours after surgery
Plasma S100B concentration
Time frame: Baseline, 24, 48, and 72 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Background: PubMed 32994986Zhang C, Foo I. Is intravenous lidocaine protective against myocardial ischaemia and reperfusion injury after cardiac surgery? Ann Med Surg (Lond). 2020 Sep 11;59:72-75. doi: 10.1016/j.amsu.2020.09.008. eCollection 2020 Nov.
- Background: PubMed 39780778Gregory AJ, Arora RC, Chatterjee S, Crisafi C, Morton-Bailey V, Rea A, Salenger R, Engelman DT, Grant MC; ERAS Cardiac Working Group. Enhanced Recovery After Surgery (ERAS) cardiac turnkey order set for perioperative pain management in cardiac surgery: Proceedings from the American Association for Thoracic Surgery (AATS) ERAS Conclave 2023. JTCVS Open. 2024 Sep 6;22:14-24. doi: 10.1016/j.xjon.2024.08.018. eCollection 2024 Dec.
- Background: PubMed 29609129Wang L, Wang M, Li S, Wu H, Shen Q, Zhang S, Fang L, Liu R. Nebulized lidocaine ameliorates allergic airway inflammation via downregulation of TLR2. Mol Immunol. 2018 May;97:94-100. doi: 10.1016/j.molimm.2018.03.010. Epub 2018 Mar 30.
- Background: PubMed 20740215Lee JM, Suh JK, Jeong JS, Cho SY, Kim DW. Antioxidant effect of lidocaine and procaine on reactive oxygen species-induced endothelial dysfunction in the rabbit abdominal aorta. Korean J Anesthesiol. 2010 Aug;59(2):104-10. doi: 10.4097/kjae.2010.59.2.104. Epub 2010 Aug 20.
- Background: PubMed 37408557Kavcic H, Jug U, Mavri J, Umek N. Antioxidant activity of lidocaine, bupivacaine, and ropivacaine in aqueous and lipophilic environments: an experimental and computational study. Front Chem. 2023 Jun 20;11:1208843. doi: 10.3389/fchem.2023.1208843. eCollection 2023.
- Background: PubMed 29864216Weibel S, Jelting Y, Pace NL, Helf A, Eberhart LH, Hahnenkamp K, Hollmann MW, Poepping DM, Schnabel A, Kranke P. Continuous intravenous perioperative lidocaine infusion for postoperative pain and recovery in adults. Cochrane Database Syst Rev. 2018 Jun 4;6(6):CD009642. doi: 10.1002/14651858.CD009642.pub3.
- Background: PubMed 36933017Simonato M, Padalino M, Vedovelli L, Carollo C, Sartori A, Vida V, Gregori D, Carnielli V, Cogo P. Effect of preoperative pulmonary hemodynamic and cardiopulmonary bypass on lung function in children with congenital heart disease. Eur J Pediatr. 2023 Jun;182(6):2549-2557. doi: 10.1007/s00431-023-04926-0. Epub 2023 Mar 18.
- Background: PubMed 35094928Fischer MO, Brotons F, Briant AR, Suehiro K, Gozdzik W, Sponholz C, Kirkeby-Garstad I, Joosten A, Nigro Neto C, Kunstyr J, Parienti JJ, Abou-Arab O, Ouattara A; VENICE study group. Postoperative Pulmonary Complications After Cardiac Surgery: The VENICE International Cohort Study. J Cardiothorac Vasc Anesth. 2022 Aug;36(8 Pt A):2344-2351. doi: 10.1053/j.jvca.2021.12.024. Epub 2021 Dec 25.
- Background: PubMed 33666100Jenke A, Yazdanyar M, Miyahara S, Chekhoeva A, Immohr MB, Kistner J, Boeken U, Lichtenberg A, Akhyari P. AdipoRon Attenuates Inflammation and Impairment of Cardiac Function Associated With Cardiopulmonary Bypass-Induced Systemic Inflammatory Response Syndrome. J Am Heart Assoc. 2021 Mar 16;10(6):e018097. doi: 10.1161/JAHA.120.018097. Epub 2021 Mar 5.
- Background: PubMed 32984825Sperotto F, Cogo P, Amigoni A, Pettenazzo A, Thiagarajan RR, Polito A. Extracorporeal Membrane Oxygenation Support for Failure to Wean From Cardiopulmonary Bypass After Pediatric Cardiac Surgery: Analysis of Extracorporeal Life Support Organization Registry Data. Crit Care Explor. 2020 Sep 15;2(9):e0183. doi: 10.1097/CCE.0000000000000183. eCollection 2020 Sep.
- Background: PubMed 34989703Cholette JM, Muszynski JA, Ibla JC, Emani S, Steiner ME, Vogel AM, Parker RI, Nellis ME, Bembea MM; Pediatric Critical Care Transfusion and Anemia EXpertise Initiative-Control/Avoidance of Bleeding (TAXI-CAB), in collaboration with the Pediatric Critical Care Blood Research Network (BloodNet), and the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network. Plasma and Platelet Transfusions Strategies in Neonates and Children Undergoing Cardiac Surgery With Cardiopulmonary Bypass or Neonates and Children Supported by Extracorporeal Membrane Oxygenation: From the Transfusion and Anemia EXpertise Initiative-Control/Avoidance of Bleeding. Pediatr Crit Care Med. 2022 Jan 1;23(13 Supple 1 1S):e25-e36. doi: 10.1097/PCC.0000000000002856.
- Individual participant dataSharing planned: Undecided
Related trials for Congenital Heart Disease
Not yet recruiting
Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study
Congenital Heart Disease (CHD)
RecruitingPhase 1
A Study of SGT-212 Gene Therapy in Friedreich's Ataxia
Friedreich's Ataxia (FA)
RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
RecruitingObservational study
Essen Amyloidosis Registry
Amyloidosis; Systemic, Amyloidosis Cardiac
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine %2 ampoule and Normal Saline (0.9% NaCl) in people with Congenital Heart Disease and Postoperative Pulmonary Complications, run by The Children's Hospital of Zhejiang University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiangming Fan, MD, PhD (+86 13616532813, fanxiangming@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Lung Injury Score within 72 hours after surgery (time frame: Assessed at 0, 12, 24, 36, 48, 60, and 72 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07499154, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.