Trial · NCT06702553
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Composite outcome of death and major adverse events requiring intensive life supports | within 30 days after operation | It is composite outcome including: * all cause mortality; * ischemic events(myocardial infarction, ischemic stroke, and pulmonary embolism) , * Cardiac arrest that had been successfully resuscitated or new onset of acute cardiac failure (low output syndrome) requiring IABP, ECMO, left ventricular assist device, cardiac dysfunction need for large dose of inotrope support, ---Stage 3 AKI or Renal failure that required renal replacement therapy, * prolonged mechanical ventilation (\> 24h ), * re-sternotomy for any indication, * major arrhythmia ((Ventricular fibrilliation or ventricular tachycardia after weaning-off cardiopulmonary bypass, new onset atrial fibrillation requiring anticoagulant therapy or other intervention upon discharge from the hospital); * sepsis |
| Secondary | Total number of major adverse events (MAEs) | within 30 days after operation | Total number of major adverse events( MAEs) listed as the components of the primary outcomes. |
| Secondary | Incidence of the MAEs | within 30 days after operation | Incidence of the MAEs listed as the components of the primary outcomes. |
| Secondary | All AKI incidence | within 7 days of surgery | AKI incidence which will be diagnosed by KDIGO criteria |
| Secondary | Length of mechanical ventilation | within 30 days after operation | Length of mechanical ventilation in hours |
| Secondary | Readmission | within 30 days after operation | Readmission after hospital discharge |
| Secondary | Length of ICU stay | From the date of surgery until the date patient discharge from hospital, assessed up to 1 year | Length of postoperative ICU stay |
| Secondary | Length of postprocedural hospital stays | From the date of surgery until the date patient discharge from hospital, assessed up to 1 year. | Length of postprocedural hospital stays |
| Secondary | All cause 90 d mortality | within 90 days after operation | Death within 90 days after surgery for any reason |
| Secondary | All cause 1 year mortality | within 1 year after operation | Death within 1 year after surgery. |
| Secondary | Change in organ-specific and total sepsis-related SOFA scores | from the day of surgery to postoperative day 7. | Change in organ-specific and total sepsis-related Sequential Organ Failure Assessment (SOFA) scores from enrollment through study day 7. |
| Secondary | Basal level of hemolysis | after entering operation room and before anaesthesia induction | Serum free hemoglobin levels at baseline (g/L) |
| Secondary | Incidence of acute intraoperative hemolysis | Immediately after the end of cardiopulmonary bypass (CPB) | measurement will be defined based on the level of free hemoglobin after CPB. |
| Secondary | The extent of hemolysis progression | taken at immediately after CPB finishes | Measured based on the free hemoglobin levels at baseline and immediately after CPB (free hemoglobin levels immediately after CPB/ baseline free hemoglobin) |
| Other | Blood transfusion | during postoperative hospitalization, with an average of 10 days | Amount of each type of blood product transfused (red blood cells, fresh frozen plasma, platelets) |
| Other | Blood loss | during the first 72 hours after surgery | Total amount of blood loss (chest tube drainage) in ml |
| Other | Incidence of prolonged cardiovascular support | during postoperative hospitalization, with an average of 10 days. | cardiovascular support by using inotropes for more than 48 hours |
| Other | Maximum vasoactive-inotropic score (VIS) | record the maximun of the day for the first 7 days after surgery | The VIS will be calculated using the formula: Dopamine dose (mcg/Kg/min) + Dobutamine dose (mcg/Kg/min) + 100 x Epinephrine dose (mcg/Kg/min) + 100 x Norepinephrine dose (mcg/Kg/min) + 50 x Levosimendan dose (mcg/Kg/min) + Enoximone dose (mcg/Kg/min) + 10.000 x Vasopressin dose (UI/kg/min). The maximum VIS will be recorded each day. |
| Other | local infections | within 30 days after surgery. | Postoperative local infections, including pneumonia, deep sternal wound infection/mediastinitis, endocarditis, central line infection, and urinary tract infection. |
| Other | Other non-cardiac postoperative complications | within 30 days after surgery | including hepatobiliary disorders, pneumothorax, pleural effusion, and delirium |
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.
For software
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