Trial · NCT07194304
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Serum Troponin I Concentration (ng/L) | Before surgery, 1 hour after surgery, and 8 hours after surgery | Serum Troponin I concentration will be measured at baseline (before surgery), 1 hour after surgery, and 8 hours after surgery to assess the extent of myocardial injury associated with cardiopulmonary bypass during Tetralogy of Fallot repair. |
| Secondary | Change in Serum Malondialdehyde (MDA) Concentration (ng/mL) | Before surgery, 1 hour after surgery, and 8 hours after surgery | Serum malondialdehyde (MDA), a biomarker of oxidative stress, will be measured at baseline (before surgery), 1 hour after surgery, and 8 hours after surgery to evaluate oxidative injury associated with cardiopulmonary bypass during Tetralogy of Fallot repair. |
| Secondary | Change in Serum Lactate Concentration (mmol/L) | Before surgery, 1 hour, 6 hours, 12 hours, and 24 hours after surgery | Serum lactate levels will be measured at baseline (before surgery), and at 1 hour, 6 hours, 12 hours, and 24 hours after surgery to evaluate tissue perfusion and metabolic response associated with cardiopulmonary bypass during Tetralogy of Fallot repair. |
| Secondary | Myocardial Injury Score (Histopathology, Scale 0-3) | 15 minutes after release of the aortic cross-clamp | Myocardial tissue injury will be assessed from biopsy samples collected 15 minutes after release of the aortic cross-clamp. Injury will be graded on a histopathological scale ranging from 0 to 3, where 0 = no injury and 3 = severe injury. Higher scores indicate worse myocardial damage. |
| Secondary | Apoptotic Index (% of Apoptotic Cardiomyocytes) | tissue sample is collected 15 minutes after releasing the aortic cross clamp | The apoptotic index will be calculated from myocardial tissue samples collected 15 minutes after release of the aortic cross-clamp. Sections are stained with TUNEL and examined at 40× magnification across 6 hotspot areas. The index is expressed as the percentage of TUNEL-positive cardiomyocytes per 100 cardiomyocytes. The scale ranges from 0% (no apoptosis) to 100% (all cells apoptotic). Higher values indicate greater myocardial apoptosis. |
| Secondary | Duration of Mechanical Ventilation (hours) | From end of surgery until extubation | Duration of postoperative mechanical ventilation will be recorded in hours. |
| Secondary | anti-cTnI | tissue sample is collected 15 minutes after releasing the aortic cross clamp | |
| Secondary | GPx expression | tissue sample is collected 15 minutes after releasing the aortic cross clamp | |
| Secondary | Intensive Care Unit Length of Stay (days) | From ICU admission until ICU discharge, assessed up to 14 days | ICU length of stay will be recorded in days from ICU admission until ICU discharge. |
| Secondary | Hospital Length of Stay (days) | From hospital admission until hospital discharge, assessed up to 30 days | Hospital length of stay will be recorded in days from hospital admission until discharge. |
| Secondary | Vasoactive-Inotropic Score (VIS, Scale 0-X) | First 24 hours after surgery | Vasoactive-Inotropic Score (VIS) will be calculated to quantify the amount of vasoactive support required after surgery. The VIS scale ranges from 0 to an open-ended maximum value; higher scores indicate greater need for vasoactive support and worse hemodynamic status. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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