Association Between Early Postoperative L-Arginine Administration and Acute Kidney Injury Following Cardiac Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 5,135
- Locations
- 2
- Primary Endpoint
- incidence of postoperative AKI
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Without Arginine
No L-arginie was administered
Arginine Use
At least one dose of L-arginie was administered in the early postoperative stage
Intervention: L-Arginine hydrochloride (Drug)
Outcomes
Primary Outcomes
incidence of postoperative AKI
Time Frame: 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 Outcomes
- 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)
- 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)
- 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)
Investigators
Chong Lei, MD & phD
Principal Investigator
Xijing Hospital