Lung Injury, Acute Clinical Trial
— CPBOfficial title:
Serum Level of Calpains Product as a Novel Biomarker of Acute Lung Injury Following Cardiopulmonary Bypass(CPB)
Verified date | October 2022 |
Source | Yangzhou University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
More than 2 million patients worldwide receive heart surgery every year, majority of these surgical patients will undergo cardiopulmonary bypass. However, the incidence of postoperative acute lung injury due to cardiopulmonary bypass is still as high as 20% to 35%. According to clinical experience, the earlier lung damage is detected, the more successful the treatment will be. On the basis of traditional detection, the investigators found a new indicator, serum calpains, which are easy to obtain and have certain specificity. Importantly, they can predict postoperative acute lung injury within 1 hour after cardiac surgery. It is meaningful that this indicator can provide clinicians with early decision-making advice and immediate treatment for patients who may be at risk.
Status | Completed |
Enrollment | 100 |
Est. completion date | August 1, 2022 |
Est. primary completion date | August 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age = 18 years; - Underwent cardiac surgery using CPB technology. Exclusion criteria : - Patient's lack of consent to participate; - Presence of abnormal liver, kidney or other organ function; - Pulmonary inflammation, chronic obstructive pulmonary disease or tumors; - Underwent cardiac surgery without CPB technology; - Postoperative need for extracorporeal membrane oxygenation support. |
Country | Name | City | State |
---|---|---|---|
China | the Affiliated Hospital of Yangzhou University | Yangzhou | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Yangzhou University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PaO2/FiO2 ratio | The ratio of inspiratory oxygen fraction to oxygen pressure (PaO2/FiO2) was calculated. | Change from beginning of CPB to 48 h after CPB | |
Primary | lung-injury scores | A structured tutorial was used to establish consensus in the interpretation of radiographs for radiographic lung-injury scores, range from 0 to 4.
0: No alveolar consolidation; 1: Alveolar consolidation confined to 1 quadrant; 2: Alveolar consolidation confined to 2 quadrants 3: Alveolar consolidation confined to 3 quadrants; 4: Alveolar consolidation in all 4 quadrants. The higher scores mean a worse outcome. |
The 24 and 48 hours after CPB | |
Secondary | Perioperative serum calpains' concentrations | Serial serum samples were obtained and measured by using a fluorometric kit (Abcam, Cambridge, UK) according to the manufacturer's protocol. | The day before CPB and 1, 12, 24, 48 hours after CPB |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00498251 -
Prevention of Lung Edema After Thoracic Surgery
|
N/A | |
Completed |
NCT01597635 -
The Safety, Tolerability, PK and PD of GSK2586881 in Patients With Acute Lung Injury
|
Phase 2 | |
Completed |
NCT00141726 -
Study of Enbrel (Etanercept) for the Treatment Sub-Acute Pulmonary Dysfunction After Allogeneic Stem Cell Transplant
|
Phase 2 | |
Completed |
NCT00996840 -
SB-681323 IV for Subjects at Risk of Acute Lung Injury or ARDS
|
Phase 2 | |
Completed |
NCT03651817 -
Lung Protection Strategy in Open Heart Surgery: Which Tidal Volume is Better 8ml/kg or 6ml/kg
|
N/A | |
Recruiting |
NCT05680831 -
Pulmonary and Inflammatory Responses Following Exposure to a Low Concentration of Ozone or Clean Air
|
Phase 1 | |
Completed |
NCT03764319 -
Low Frequency, Ultra-low Tidal Volume Ventilation in Patients With ARDS and ECMO
|
N/A | |
Completed |
NCT01640990 -
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of an Intravenous Infusion of GW328267X in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT01114009 -
Effects of Recruitment Maneuvers in Early Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS) Patients
|
N/A | |
Terminated |
NCT00715338 -
Effects of Oxygen on Lung Tissue During Anesthesia
|
N/A | |
Recruiting |
NCT03202641 -
Open Lung Strategy, Gas Distribution and Right Heart Function in ARDS Patients
|
N/A | |
Completed |
NCT03828630 -
Lung Ultrasound to Detect Pulmonary Complications in Critically Ill Parturients
|
||
Completed |
NCT03905837 -
Impact of Lidocaine Administration on Postoperative Complications During Lung Resection Surgery
|
Phase 4 | |
Completed |
NCT03023670 -
Lung Protection and Pediatric Cardiac Surgery
|
N/A | |
Recruiting |
NCT05647967 -
Features of Regional Perfusion of Lung Consolidation
|
||
Recruiting |
NCT04289324 -
Open Lung Maneuvers During High Frequency Oscillatory Ventilation in Preterm Infants
|
N/A | |
Completed |
NCT05647382 -
Soluble VE-cadherin in Prediction and Diagnosis of Early Postoperative Hypoxemia After Cardiopulmonary Bypass
|
N/A | |
Recruiting |
NCT04511923 -
Nebulised Heparin to Reduce COVID-19 Induced Acute Lung Injury
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03637530 -
a Study Conducted About a New Mode of Ventilation in Laparoscopic Surgeries
|
N/A | |
Completed |
NCT04344184 -
SAFEty Study of Early Infusion of Vitamin C for Treatment of Novel Coronavirus Acute Lung Injury (SAFE EVICT CORONA-ALI)
|
Phase 2 |