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

NCT07718373 | Not Yet Recruiting

• 1 other identifier: KY20232170
• Study Type: observational
• Target: 5,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Acute kidney injury

  defined by KDIGO criteria

  within 7 postoperative days

Secondary Outcomes (2)

• Acute kidney injury stage

  within 7 postoperative days

• in-hospital mortality.

  up to 48 weeks

Study Arms (2)

L-arginine

Initiation of L-arginine within 3 postoperative days

Drug: L-arginine

No L-arginine

No L-arginine therapy within 3 postoperative days

Interventions

L-arginine DRUG

Initiation of L-arginine within 3 postoperative days

L-arginine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adults admitted to the ICU after CPB-assisted cardiac surgery

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xijing Hospital: lead

Related Publications (2)

• 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.

  PMID: 29932345 BACKGROUND

• 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.

  PMID: 38865168 BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Arginine

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential

Central Study Contacts

Zefei Zhang

CONTACT

18811797795; zzfanita7@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Head of Anesthesia Clinical Research Center, Xijing Hospital

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 22, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): August 20, 2026
• Study Completion (Estimated): August 20, 2026
• Last Updated: July 22, 2026

Record last verified: 2026-07