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CompletedNCT05610475CPBUpdated Nov 14, 2022

Serum Level of Calpains Product as a Novel Biomarker of Acute Lung Injury Following Cardiopulmonary Bypass

An interventional study of blood cell analysis, blood gas surveillance, chest radiograph and echocardiography in Lung Injury, Acute, sponsored by Yangzhou University. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-14.

Sponsored by Yangzhou University · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Feb 2022, registered Oct 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Lung Injury, Acute

Keywords

  • Cardiopulmonary Bypass
  • Calpain
  • Lung injury
03

In context

Lung Injury

399 studies on the registry are indexed under Lung Injury; 50 are open to participants now.

This study's enrollment of 100 is above the median of 53 across 239 interventional studies indexed under Lung Injury.

Browse Lung Injury studies →

Lead sponsor

Yangzhou University is the lead sponsor of 40 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age ≥ 18 years;
  • Underwent cardiac surgery using CPB technology.

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Active comparator
    Lung injury group

    Diagnostic Test: blood cell analysis, blood gas surveillance, chest radiograph and echocardiography

  • Sham comparator
    Non-lung injury group

    Diagnostic Test: blood cell analysis, blood gas surveillance, chest radiograph and echocardiography

Interventions

  • Diagnostic testblood cell analysis, blood gas surveillance, chest radiograph and echocardiography

    Laboratory parameters of all postoperative patients including blood cell analysis, blood gas surveillance, liver, and kidney function alone with chest radiograph and echocardiography were dynamically monitored.

06

What researchers measure

Primary outcomes

  1. PaO2/FiO2 ratio

    The ratio of inspiratory oxygen fraction to oxygen pressure (PaO2/FiO2) was calculated.

    Time frame: Change from beginning of CPB to 48 h after CPB

  2. 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.

    Time frame: The 24 and 48 hours after CPB

Secondary outcomes

  1. 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.

    Time frame: The day before CPB and 1, 12, 24, 48 hours after CPB

07

Study locations

1 site
  • the Affiliated Hospital of Yangzhou University
    Yangzhou, Jiangsu 225000, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05610475
Lead sponsor
Yangzhou University
Responsible party
Zhuan Zhang (Director, Yangzhou University) — Principal investigator
First posted
Nov 9, 2022
Start date
Feb 1, 2022
Primary completion
Aug 1, 2022
Completion
Aug 1, 2022
Last update
Nov 14, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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