Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-25 @ 3:48 AM
NCT ID:
NCT05300802
Eligibility Criteria:
Inclusion Criteria:
* All the patients guardian consent to participate in this study
* Patient with Cyanotic CHD who are undergoing open-heart surgery using CPB with an Aristotle score of 6-9
* Patient is aged between 1 month to 6 years
Exclusion Criteria:
* Elective surgery patients who change into an emergency case surgery
* Patient with procalcitonin levels exceeding 0.5 ng/ml with the symptoms of infection
* Patient with liver dysfunction as measured by an increase of Glutamic Oxaloacetic Transaminase (SGOT)/ Serum Glutamic Pyruvic Transaminase (SGPT) levels more than 1.5 times from baseline
* Patient with Renal dysfunction as measured by creatinine levels exceeding 2 mg/dL
Drop out Criteria:
* Duration of CPB and/or Aortic cross-clamp time exceeding 120 minutes
* Intraoperative anatomy of CHDs finding is different from the preoperative diagnosis so that the patient no longer fulfils the Aristotle score of 6-9
* Surgery requires more than two attempts of CPB
* Patient fails to wean from CPB
* Patient requires ECMO (Extracorporeal Membrane Oxygenator) postoperatively
* Patient dies on the operating table
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Month
Maximum Age:
6 Years
Study:
NCT05300802
Study Brief:
Protocol Section:
NCT05300802