Cardiac Surgery Associated Acute Kidney InjuryNCT06245720
Serum and Urine Metabolome Studies in Patients With Acute Kidney Injury After Cardiac Surgery
An observational study of Cardiac Surgery Associated Acute Kidney Injury, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
The goal of this observational study is to learn about serum and urine metabolome in patients after cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery Associated Acute Kidney Injury
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 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
- Adult, Older adult
Study population: Patients with cardiac surgery who have undergone cardiopulmonary bypass. Acute kidney injury is defined according to the KIDIGO guidelines.
Who may be able to join
- Age> 18 years old;
- after cardiopulmonary bypass;
Who cannot join
- Under the age of 18;
- Previous chronic kidney disease or receiving renal replacement therapy;
- Have a history of kidney transplantation or nephrectomy.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this observational study is to learn about serum and urine metabolome in patients after cardiac surgery.
Read the detailed description
The main objective of this study is to collect blood and urine samples from patients after cardiac surgery, and to perform metabolomic analysis to find the differential metabolites and their enrichment pathways in AKI patients and non-AKI patients.The secondary objective is to intervene in its enrichment pathway to find ways to improve CSA-AKI.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
| Study group | Role | What they receive |
|---|---|---|
| AKI group | AKI is then defined as an increase in serum creatinine (SCr) of at least 26.4 μmol/L over 48 hours, or an increase in SCr greater than 1.5 times baseline over 7 days, or a urine output of less than 0.5 mL/kg per hour for more than 6 hours, according to the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines. | |
| Non-AKI group | According to the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines, patients do not develop acute kidney injury. |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum and urine metabolome studies
The preoperative and postoperative metabolomic differences in blood and urine between AKI group and non-AKI group were compared.
Measured: January 2025 - December 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start1 Jan 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Surgery Associated Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe 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
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chen Wenxiu, Principal investigator, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06245720
- Sponsor's protocol ID
- KY20240123-01
- Status last verified
- Jan 2024
- First submitted
- 30 Jan 2024
- Last updated
- 7 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum and Urine Metabolome Studies in Patients With Acute Kidney Injury After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06245720
- Acronym / sponsor ID
- KY20240123-01
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 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.
The goal of this observational study is to learn about serum and urine metabolome in patients after cardiac surgery.
Detailed description
The main objective of this study is to collect blood and urine samples from patients after cardiac surgery, and to perform metabolomic analysis to find the differential metabolites and their enrichment pathways in AKI patients and non-AKI patients.The secondary objective is to intervene in its enrichment pathway to find ways to improve CSA-AKI.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AKI group | – | –AKI is then defined as an increase in serum creatinine (SCr) of at least 26.4 μmol/L over 48 hours, or an increase in SCr greater than 1.5 times baseline over 7 days, or a urine output of less than 0.5 mL/kg per hour for more than 6 hours, according to the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines. |
| Non-AKI group | – | –According to the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines, patients do not develop acute kidney injury. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with cardiac surgery who have undergone cardiopulmonary bypass. Acute kidney injury is defined according to the KIDIGO guidelines.
Key inclusion criteria (2 listed)
- Age> 18 years old;
- after cardiopulmonary bypass;
Key exclusion criteria (3 listed)
- Under the age of 18;
- Previous chronic kidney disease or receiving renal replacement therapy;
- Have a history of kidney transplantation or nephrectomy.
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 |
|---|---|---|
| Other | AKI group, Non-AKI group |
Primary outcome
serum and urine metabolome studies
Time frame: January 2025 - December 2025
The preoperative and postoperative metabolomic differences in blood and urine between AKI group and non-AKI group were compared.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
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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.
Chen Wenxiu principal investigator
Nanjing First Hospital, Nanjing Medical University
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 Cardiac Surgery Associated Acute Kidney Injury, run by Nanjing First Hospital, Nanjing Medical University 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 2 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: status not confirmed, as of the sponsor's last update on 7 Feb 2024. 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?
Results are not available in the source record.
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?
serum and urine metabolome studies (time frame: January 2025 - December 2025). 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 7 Feb 2024.