Acute Kidney Injury
Conditions
Brief summary
To investigate the association between the the early administration of L-Arginine after CPB-assisted cardiac surgery and the incidence of CS-AKI in adult patients. To test if it can reduce the incidence of post-operative AKI.
Interventions
Postoperative administration of L-Arginine hydrochloride before incidence of CS-AKI
Sponsors
Study design
Eligibility
Inclusion criteria
* adult patients (over 18 years) * underwent CPB assisted cardiac surgery * admitted to ICU
Exclusion criteria
* congenital heart disease * underwent deep hypothermic circulatory arrest (DHCA) * with glomerular filtration rate (eGFR) below 30 mL/min/1.73 m²
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of postoperative AKI | from the time of end of surgery until time of documented hospital discharge or time of death, whichever came first, assessed up to 30 days | Serum Creatinine Criteria: Increase in Serum Creatinine: An absolute increase in serum creatinine of 0.3 mg/dL (26.5 µmol/L) within 48 hours. OR a percentage increase in serum creatinine of ≥50% within 7 days. These criteria are relative to the baseline creatinine level, which is usually the recent preadmission value. Urine Output Criteria: Oliguria, defined as a urine output \<0.5 mL/kg/h for more than 6 hours. OR anuria, defined as a urine output \<100 mL in 24 hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Renal failure | from the time of end of surgery until time of documented hospital discharge or time of death, whichever came first, assessed up to 30 days | KDIGO defined AKI stage ≥ 2, or if dialysis is required for newly developed conditions KDIGO classifies AKI into three stages based on the severity: Stage 2: Increase in serum creatinine of 2.0 to 2.9 times baseline OR Urine output \<0.5 mL/kg/h for ≥12 hours. Stage 3: Increase in serum creatinine of 3.0 times baseline OR Increase in serum creatinine to ≥4.0 mg/dL OR Initiation of renal replacement therapy (RRT) OR Urine output \<0.3 mL/kg/h for ≥24 hours OR anuria for ≥12 hours. |
| in-hospital mortality | from the time of end of surgery until time of documented hospital discharge or time of death, whichever came first, assessed up to 30 days | all-cause postoperative deaths observed |
| length of in-hospital stay | from the time of end of surgery until time of documented hospital discharge or time of death, whichever came first, assessed up to 30 days | postoperative stay until discharge or death |
Countries
China