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

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06248359
• Other study ID #: KY20232170-C-1
• Status: Recruiting
• Start date: December 1, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: January 2024
• Source: Xijing Hospital
• Contact: Ziyu Zheng
• Phone: +86-13228082320
• Email: zhengziyu[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 7000
• Est. completion date: March 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

Drug:
• L-Arginine hydrochloride
Postoperative administration of L-Arginine hydrochloride before incidence of CS-AKI

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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