Association Between Postoperative Administration of L-Arginine and CSA-AKI
- Registration Number
- NCT06248359
- Lead Sponsor
- Xijing Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 7000
- adult patients (over 18 years)
- underwent CPB assisted cardiac surgery
- admitted to ICU
- congenital heart disease
- underwent deep hypothermic circulatory arrest (DHCA)
- with glomerular filtration rate (eGFR) below 30 mL/min/1.73 m²
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Arginine Use L-Arginine hydrochloride At least one dose of L-arginie was administered in the early postoperative stage
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
Trial Locations
- Locations (1)
Xijing Hospital
🇨🇳Xi'an, Shaanxi, China