Early Postoperative L-arginine and Acute Kidney Injury After Cardiac Surgery

Early Postoperative L-arginine and Acute Kidney Injury After Cardiac Surgery: a Target Trial Emulation

Acute kidney injury (AKI) is common after cardiac surgery, yet effective protective strategies remain limited. L-arginine is the substrate for endogenous nitric oxide (NO) synthesis and may improve renal perfusion and endothelial function. investigators emulated a target trial to evaluate whether early perioperative L-arginine was associated with a lower risk of AKI after cardiac surgery.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Drug: L-arginine

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Zefei Zhang; Phone Number: 18811797795; Email: zzfanita7@163.com

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

adults admitted to the ICU after CPB-assisted cardiac surgery

Description

Inclusion Criteria:

·adults admitted to the ICU after CPB-assisted cardiac surgery

Exclusion Criteria:

• congenital heart disease,
• surgery requiring deep hypothermic circulatory arrest,
• a preoperative baseline estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m²,
• AKI already present prior to ICU admission

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
L-arginine; Initiation of L-arginine within 3 postoperative days	Drug: L-arginine; Initiation of L-arginine within 3 postoperative days
No L-arginine; No L-arginine therapy within 3 postoperative days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute kidney injury	defined by KDIGO criteria	within 7 postoperative days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute kidney injury stage	defined by KDIGO criteria	within 7 postoperative days
in-hospital mortality.	in-hospital mortality.	up to 48 weeks

Collaborators and Investigators

• Sponsor: Xijing Hospital

Publications and helpful links

General Publications

• Lei C, Berra L, Rezoagli E, Yu B, Dong H, Yu S, Hou L, Chen M, Chen W, Wang H, Zheng Q, Shen J, Jin Z, Chen T, Zhao R, Christie E, Sabbisetti VS, Nordio F, Bonventre JV, Xiong L, Zapol WM. Nitric Oxide Decreases Acute Kidney Injury and Stage 3 Chronic Kidney Disease after Cardiac Surgery. Am J Respir Crit Care Med. 2018 Nov 15;198(10):1279-1287. doi: 10.1164/rccm.201710-2150OC.
• Landoni G, Monaco F, Ti LK, Baiardo Redaelli M, Bradic N, Comis M, Kotani Y, Brambillasca C, Garofalo E, Scandroglio AM, Viscido C, Paternoster G, Franco A, Porta S, Ferrod F, Calabro MG, Pisano A, Vendramin I, Barucco G, Federici F, Severi L, Belletti A, Cortegiani A, Bruni A, Galbiati C, Covino A, Baryshnikova E, Giardina G, Venditto M, Kroeller D, Nakhnoukh C, Mantovani L, Silvetti S, Licheri M, Guarracino F, Lobreglio R, Di Prima AL, Fresilli S, Labanca R, Mucchetti M, Lembo R, Losiggio R, Bove T, Ranucci M, Fominskiy E, Longhini F, Zangrillo A, Bellomo R; PROTECTION Study Group. A Randomized Trial of Intravenous Amino Acids for Kidney Protection. N Engl J Med. 2024 Aug 22;391(8):687-698. doi: 10.1056/NEJMoa2403769. Epub 2024 Jun 12.

Study record dates

Study Major Dates

• Study Start (Estimated): July 20, 2026
• Primary Completion (Estimated): August 20, 2026
• Study Completion (Estimated): August 20, 2026

Study Registration Dates

• First Submitted: July 14, 2026
• First Submitted That Met QC Criteria: July 17, 2026
• First Posted (Actual): July 22, 2026

Study Record Updates

• Last Update Posted (Actual): July 22, 2026
• Last Update Submitted That Met QC Criteria: July 17, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Renal Insufficiency; Acute Kidney Injury; Amino Acids, Peptides, and Proteins; Amino Acids; Amino Acids, Basic; Amino Acids, Diamino; Amino Acids, Essential; Arginine
• Other Study ID Numbers: KY20232170

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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