Acute Kidney InjuryNCT05871203
Changes in Gene Expression and Prognosis of Blood Immune Cells After Cardiopulmonary Bypass Surgery
An observational study of Acute Kidney Injury, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The goal of this observational study is to learn about the changes in gene expression in blood immune cells in after cardiac surgery with cardiopulmonary bypass.The main question it aims to answer is: What specific gene expression changes predict kidney damage after cardiac surgery with cardiopulmonary bypass. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Gene sequencing
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 17 May 2023to 10 Jul 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients undergoing elective major cardiac surgery under cardiopulmonary bypass
Who may be able to join
- 1) Age≥ 18 years old; 2) Cardiopulmonary bypass descending valve replacement (molding), or coronary artery bypass grafting, or macrovascular surgery.
Who cannot join
- 1) any cognitive or mental impairment that is unable to sign the informed consent form; 2) Have basic immune system and blood system diseases; 3) pregnancy; 4) Receiving radiotherapy and chemotherapy before surgery; 5) Receiving immunosuppressive drugs within six months; 6) Have participated in other interventional clinical trials within 30 days before surgery.
- Exit Criteria:
- Incomplete surgery;
- Secondary transfer in the operating room;
- Automatically request to terminate the test.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Zhejiang University anesthesiology department
Hangzhou, Zhejiang, 310000
Min Yan, Doctor, 18895386675, zryanmin@zju.edu.cn
Min Yan, Doctor
About this study
The goal of this observational study is to learn about the changes in gene expression in blood immune cells in after cardiac surgery with cardiopulmonary bypass.The main question it aims to answer is: What specific gene expression changes predict kidney damage after cardiac surgery with cardiopulmonary bypass. Participants received conventional treatment.
- Conditions
- Acute Kidney Injury
- Being tested
- Gene sequencing
- Keywords
- Acute kidney injury, Cardiopulmonary bypass, gene expression
- 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.
Gene sequencingOther
Participants were taken blood samples for gene sequencing at three time periods: before, after, and 24 hours after the end of the surgery
| Study group | Role | What they receive |
|---|---|---|
| Postoperative acute kidney injury | Not described Receives: Other: Gene sequencing | |
| Postoperative non-acute kidney injury | Not described Receives: Other: Gene sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative acute kidney injury
SCr was elevated ≥ 26.5 micromol/L or 1.5 times the baseline for SCr ≥ or urine output < 0.5 mL/kg/hour within 6 hours within 48 hours
Measured: Within 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start17 May 2023 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion10 Jul 2023 (estimated)
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 Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Prospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05871203
- Sponsor's protocol ID
- 2023-0359
- Status last verified
- May 2023
- First submitted
- 15 May 2023
- Last updated
- 23 May 2023
- Results posted
- 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 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Gene Expression and Prognosis of Blood Immune Cells After Cardiopulmonary Bypass Surgery
- ClinicalTrials.gov ID
- NCT05871203
- Acronym / sponsor ID
- 2023-0359
- Conditions
- Acute Kidney Injury
- Keywords
- Acute kidney injury, Cardiopulmonary bypass, gene expression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 17 May 2023 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 10 Jul 2023 (estimated)
- First posted
- 23 May 2023 (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 the changes in gene expression in blood immune cells in after cardiac surgery with cardiopulmonary bypass.The main question it aims to answer is: What specific gene expression changes predict kidney damage after cardiac surgery with cardiopulmonary bypass. Participants received conventional treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postoperative acute kidney injury | – | Other: Gene sequencing |
| Postoperative non-acute kidney injury | – | Other: Gene sequencing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing elective major cardiac surgery under cardiopulmonary bypass
Key inclusion criteria (1 listed)
- 1) Age≥ 18 years old; 2) Cardiopulmonary bypass descending valve replacement (molding), or coronary artery bypass grafting, or macrovascular surgery.
Key exclusion criteria (5 listed)
- 1) any cognitive or mental impairment that is unable to sign the informed consent form; 2) Have basic immune system and blood system diseases; 3) pregnancy; 4) Receiving radiotherapy and chemotherapy before surgery; 5) Receiving immunosuppressive drugs within six months; 6) Have participated in other interventional clinical trials within 30 days before surgery.
- Incomplete surgery;
- Secondary transfer in the operating room;
- Automatically request to terminate the test.
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 |
|---|---|---|
| Gene sequencingParticipants were taken blood samples for gene sequencing at three time periods: before, after, and 24 hours after the end of the surgery | Other | Postoperative acute kidney injury, Postoperative non-acute kidney injury |
Primary outcome
Postoperative acute kidney injury
Time frame: Within 48 hours after surgery
SCr was elevated ≥ 26.5 micromol/L or 1.5 times the baseline for SCr ≥ or urine output < 0.5 mL/kg/hour within 6 hours within 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
- Individual participant dataSharing planned: No
Related trials for Acute Kidney Injury
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
Recruiting
Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
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.
The Second Affiliated Hospital of Zhejiang University anesthesiology department
Hangzhou, China
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 Second Affiliated Hospital, Zhejiang University, School of Medicine 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 1 inclusion and 5 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 23 May 2023. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative acute kidney injury (time frame: Within 48 hours after surgery). 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 23 May 2023.