Acute Kidney InjuryNCT06248359
Association Between Postoperative Administration of L-Arginine and CSA-AKI
An observational study of Acute Kidney Injury, run by Xijing Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- L-Arginine hydrochloride
- How many people
- 5,135 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 1 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who were admitted to the ICU after cardiac surgery with CPB.
Who may be able to join
- adult patients (over 18 years)
- underwent CPB assisted cardiac surgery
- admitted to ICU
Who cannot join
- congenital heart disease
- underwent deep hypothermic circulatory arrest (DHCA)
- with glomerular filtration rate (eGFR) below 30 mL/min/1.73 m²
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Early Postoperative L-Arginine Administration and Acute Kidney Injury Following Cardiac Surgery
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
- Being tested
- L-Arginine hydrochloride
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-Arginine hydrochlorideDrug
Postoperative administration of L-Arginine hydrochloride before incidence of CS-AKI
| Study group | Role | What they receive |
|---|---|---|
| Arginine Use | At least one dose of L-arginie was administered in the early postoperative stage Receives: Drug: L-Arginine hydrochloride | |
| Without Arginine | No L-arginie was administered |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
all-cause postoperative deaths observed
Measured: 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
postoperative stay until discharge or death
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start1 Dec 2023
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5,135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chong Lei, MD & phD, Xijing Hospital
- Investigators
- Chong Lei, Principal investigator, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06248359
- Sponsor's protocol ID
- KY20232170-C-1
- Status last verified
- Aug 2026
- First submitted
- 24 Jan 2024
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Early Postoperative L-Arginine Administration and Acute Kidney Injury Following Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06248359
- Acronym / sponsor ID
- KY20232170-C-1
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,135 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arginine Use | – | Drug: L-Arginine hydrochlorideAt least one dose of L-arginie was administered in the early postoperative stage |
| Without Arginine | – | –No L-arginie was administered |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who were admitted to the ICU after cardiac surgery with CPB.
Key inclusion criteria (3 listed)
- adult patients (over 18 years)
- underwent CPB assisted cardiac surgery
- admitted to ICU
Key exclusion criteria (3 listed)
- congenital heart disease
- underwent deep hypothermic circulatory arrest (DHCA)
- with glomerular filtration rate (eGFR) below 30 mL/min/1.73 m²
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-Arginine hydrochloridePostoperative administration of L-Arginine hydrochloride before incidence of CS-AKI | Drug | Arginine Use |
Primary outcome
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.
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chong Lei principal investigator
Xijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.