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Association Between Postoperative Administration of L-Arginine and CSA-AKI

Association Between Early Postoperative L-Arginine Administration and Acute Kidney Injury Following Cardiac Surgery

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06248359
Enrollment
7000
Registered
2024-02-08
Start date
2023-12-01
Completion date
2025-12-01
Last updated
2025-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury

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

Xijing Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
incidence of postoperative AKIfrom the time of end of surgery until time of documented hospital discharge or time of death, whichever came first, assessed up to 30 daysSerum 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

MeasureTime frameDescription
Renal failurefrom the time of end of surgery until time of documented hospital discharge or time of death, whichever came first, assessed up to 30 daysKDIGO 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 mortalityfrom the time of end of surgery until time of documented hospital discharge or time of death, whichever came first, assessed up to 30 daysall-cause postoperative deaths observed
length of in-hospital stayfrom the time of end of surgery until time of documented hospital discharge or time of death, whichever came first, assessed up to 30 dayspostoperative stay until discharge or death

Countries

China

Contacts

Primary ContactZiyu Zheng
zhengziyu@126.com+86-13228082320

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026