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

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

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 Overview

• Status: Recruiting
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Drug: L-Arginine hydrochloride

• Study Type: Observational
• Enrollment (Estimated): 7000

Contacts and Locations

• Study Contact: Name: Ziyu Zheng; Phone Number: +86-13228082320; Email: zhengziyu@126.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • Xijing Hospital
      • Contact: Chong Lei, MD & phD; Phone Number: 86-18629011362; Email: crystalleichong@126.com
      • Contact: lini Wang, MD; Phone Number: 86-15209234508; Email: wangln238@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients who were admitted to the ICU after cardiac surgery with CPB.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Arginine Use; At least one dose of L-arginie was administered in the early postoperative stage	Drug: L-Arginine hydrochloride; Postoperative administration of L-Arginine hydrochloride before incidence of CS-AKI
Without Arginine; No L-arginie was administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of postoperative AKI	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.	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Renal failure	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.	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	all-cause postoperative deaths observed	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
length of in-hospital stay	postoperative stay until discharge or death	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

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Investigators: Principal Investigator: Chong Lei, Xijing Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: January 24, 2024
• First Submitted That Met QC Criteria: January 31, 2024
• First Posted (Actual): February 8, 2024

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Acute Kidney Injury
• Other Study ID Numbers: KY20232170-C-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No