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

NCT06248359 | Recruiting

• 1 other identifier: KY20232170-C-1
• Study Type: observational
• Target: 7,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• 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

Study Arms (2)

Arginine Use

At least one dose of L-arginie was administered in the early postoperative stage

Drug: L-Arginine hydrochloride

Without Arginine

No L-arginie was administered

Interventions

L-Arginine hydrochloride DRUG

Postoperative administration of L-Arginine hydrochloride before incidence of CS-AKI

Arginine Use

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

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

You may qualify if:

• adult patients (over 18 years)
• underwent CPB assisted cardiac surgery
• admitted to ICU

You may not qualify if:

• congenital heart disease
• underwent deep hypothermic circulatory arrest (DHCA)
• with glomerular filtration rate (eGFR) below 30 mL/min/1.73 m²

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

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

Study Officials

• Chong Lei

  Xijing Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ziyu Zheng

CONTACT

+86-13228082320; zhengziyu@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 8, 2024
• Study Start: December 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)