The Effect of Ulistin on Acute Renal Injury in Patients Undergoing OPCAB (Off Pump Coronary Artery Bypass): a Propensity Score Matched Study
Tylko zarejestrowani użytkownicy mogą tłumaczyć artykuły
Zaloguj się Zarejestruj się
Link zostanie zapisany w schowku
StatusJeszcze nie rekrutuję
Sponsorzy
Ajou University School of Medicine
BADANIE KLINICZNE: NCT04473144
BioSeek: nct04473144
Słowa kluczowe
Abstrakcyjny
Acute kidney injury (AKI) is a frequent complication after cardiac surgery. AKI has been reported as 7-40% depending on the type of surgery, and is known to increase to about 50% when there are risk factors. Cardiac surgery-associated AKI (CSA-AKI) requires cardiac replacement therapy in 1-5% of patients and increases mortality to 1,4%, but the treatment is still unknown. Therefore prevention of occurrence is very important.
Known factors related to the development of CSA-AKI include hemodynamic, inflammatory, metabolic, and nephrotoxic factors, and since there is a close connection between hypotension due to deterioration of cardiac function, preventive measures to prevent hypotension in juicing It is only possible.
To date, strategies to protect kidneys with drugs are very limited. Urinary trypsin inhibitor, ulistine, has anti-inflammatory and antioxidant effects, so it has been reported to protect against renal ischemia/reperfusion injury. Various studies have been attempted to prevent CSA-AKI, but most of them are inflammatory reactions during surgery. It was performed only for surgery with extracorporeal circulation that causes severely.
Therefore, this study would like to verify the effectiveness of ulistine's medicine in the prevention of CSA-AKI in patients undergoing coronary artery bypass surgery without extracorporeal circulation.
Daktyle
| Ostatnia weryfikacja: | 06/30/2020 |
| Pierwsze przesłane: | 07/07/2020 |
| Szacowana liczba przesłanych rejestracji: | 07/14/2020 |
| Wysłany pierwszy: | 07/15/2020 |
| Ostatnia aktualizacja przesłana: | 07/14/2020 |
| Ostatnia opublikowana aktualizacja: | 07/15/2020 |
| Rzeczywista data rozpoczęcia badania: | 07/31/2020 |
| Szacowana data zakończenia podstawowej działalności: | 06/30/2021 |
| Szacowana data zakończenia badania: | 08/30/2021 |
Stan lub choroba
Acute Kidney Injury
Interwencja / leczenie
Drug: Ulistin
Faza
-
Grupy ramion
| Ramię | Interwencja / leczenie |
|---|---|
| No Intervention: Control Anesthesia induction and maintenance and postoperative recovery management were performed according to the standard anesthesia protocol for off pump coronary artery bypass surgery. | |
| Sham Comparator: Ulistin In the Ulistine administration group, 300,000 KIU was mixed with 100 mL physiological saline and administered over 15 minutes after induction of anesthesia.
Anesthesia induction and maintenance and postoperative recovery management were performed according to the standard anesthesia protocol for off pump coronary artery bypass surgery. | Drug: Ulistin In the Ulistine administration group, 300,000 KIU was mixed with 100 mL physiological saline and administered over 15 minutes after induction of anesthesia. |
Kryteria kwalifikacji
| Wiek kwalifikujący się do nauki | 19 Years Do 19 Years |
| Płeć kwalifikująca się do nauki | All |
| Przyjmuje zdrowych wolontariuszy | tak |
| Kryteria | Inclusion Criteria: - From January 2015 to June 2020, a retrospective study will be conducted on patients undergoing extracorporeal circulatory coronary artery bypass surgery at Ajou University Hospital. Exclusion Criteria: - Patients who were undergoing renal replacement therapy prior to surgery due to end-stage renal failure are excluded from the study. |
Wynik
Podstawowe miary wyników
1. The incidence of acute kidney injury [7 days after operation]
Cr ≥ 0.3 mg/dl within 48 hours after surgery, 1.5 times higher preoperative value within 7 days, urine volume <0.5 ml/kg for 6 hours after surgery
