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NCT Number: NCT06248359

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

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.

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

L-Arginine hydrochloride

Drug

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

Primary outcomes

  1. incidence of postoperative AKI

    Time frame: 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

    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.

Secondary outcomes

  1. Renal failure

    Time frame: 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

    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.

  2. in-hospital mortality

    Time frame: 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

    all-cause postoperative deaths observed

  3. length of in-hospital stay

    Time frame: 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

    postoperative stay until discharge or death

Study contacts

Contact information is provided by the study sponsor or research team.

Ziyu Zheng

CONTACT

[email protected]

+86-13228082320

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 8, 2024
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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