Acute Kidney InjuryNCT04317196
Association of Copy Number Variations in the SMN Genes With Acute Kidney Injury After Heart Surgery
An observational study of Acute Kidney Injury, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
This prospective cohort study aims to explore the susceptibility to acute kidney injury after heart surgery in SMN1+/- genotype population. This study also aims to analysis the effect of SMN1+/- genotype on postoperative AKI and the development of chronic kidney disease, as well as dose-compensating effect of… Read more about this study
- Who is it for?
- Ages 1 month to 80 years
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 1,206 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2020to 1 Sep 2022
- 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 1 month to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients from Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Who may be able to join
- Age: Children (1 month -17 years old) and adults (18-80 years old);
- Sex: All;
- Those who will receive selective cardiac surgery with cardiopulmonary bypass;
- Those who signed the informed consent.
Who cannot join
- Those with glomerular filtration rate: eGFR<15ml/min/1.73m2, and those who have received the renal replacement therapy before surgery;
- Those who have received nephrectomy and kidney transplantation;
- Those who have suffered from AKI before;
- Those with incomplete medical history or clinical data.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
Fujun Lin, +86-13917983703, linfujun@xinhuamed.com.cn
About this study
Official title: Molecular Epidemiology Study of the Association of Copy Number Variations in the SMN Genes With Acute Kidney Injury After Heart Surgery
This prospective cohort study aims to explore the susceptibility to acute kidney injury after heart surgery in SMN1+/- genotype population. This study also aims to analysis the effect of SMN1+/- genotype on postoperative AKI and the development of chronic kidney disease, as well as dose-compensating effect of different copy number of SMN2 gene on SMN1 +/- genotype.
Read the detailed description
This prospective cohort study aims to explore the susceptibility to acute kidney injury after heart surgery in SMN1+/- genotype population. Real-time PCR is used to detect copy number variations in the peripheral blood SMN gene on 1206 patients with heart surgery. This study also aims to analysis the effect of SMN1+/- genotype on postoperative AKI and the development of chronic kidney disease, as well as dose-compensating effect of different copy number of SMN2 gene on SMN1 +/- genotype.
- Conditions
- Acute Kidney Injury
- Medical subject headings
- Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with occurrence of acute kidney injury (AKI) after cardiac surgery
The definition of the occurrence of acute kidney injury is according to the acute kidney injury (AKI) definition and staging criteria released by Kidney Disease: Improving Global Outcomes (KDIGO) in the year 2012
Measured: 48 hours
Secondary outcomes (2)
Number of participants with occurrence of acute kidney disease (AKD) after cardiac surgery
The definition of the occurrence of acute kidney disease is according to the acute kidney disease (AKD) definition criteria released by Kidney Disease: Improving Global Outcomes (KDIGO) in the year 2012
Measured: 3 months
Glomerular Filtration Rate(GFR)
Glomerular filtration rate (GFR) is defined as the volume of plasma that is filtered by the glomeruli per unit of time, and is usually measured by estimating the rate of clearance of a substance from the plasma.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2020
- Study start1 Apr 2020
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Sep 2022 (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 Xinhua Hospital, Shanghai Jiao Tong 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
- 1,206 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04317196
- Sponsor's protocol ID
- XHEC-C-2019-111
- Status last verified
- Jul 2019
- First submitted
- 26 Nov 2019
- Last updated
- 12 May 2020
- 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 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Epidemiology Study of the Association of Copy Number Variations in the SMN Genes With Acute Kidney Injury After Heart Surgery
- ClinicalTrials.gov ID
- NCT04317196
- Acronym / sponsor ID
- XHEC-C-2019-111
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,206 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 23 Mar 2020 (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.
This prospective cohort study aims to explore the susceptibility to acute kidney injury after heart surgery in SMN1+/- genotype population. This study also aims to analysis the effect of SMN1+/- genotype on postoperative AKI and the development of chronic kidney disease, as well as dose-compensating effect of different copy number of SMN2 gene on SMN1 +/- genotype.
Detailed description
This prospective cohort study aims to explore the susceptibility to acute kidney injury after heart surgery in SMN1+/- genotype population. Real-time PCR is used to detect copy number variations in the peripheral blood SMN gene on 1206 patients with heart surgery. This study also aims to analysis the effect of SMN1+/- genotype on postoperative AKI and the development of chronic kidney disease, as well as dose-compensating effect of different copy number of SMN2 gene on SMN1 +/- genotype.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients from Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Key inclusion criteria (4 listed)
- Age: Children (1 month -17 years old) and adults (18-80 years old);
- Sex: All;
- Those who will receive selective cardiac surgery with cardiopulmonary bypass;
- Those who signed the informed consent.
Key exclusion criteria (4 listed)
- Those with glomerular filtration rate: eGFR<15ml/min/1.73m2, and those who have received the renal replacement therapy before surgery;
- Those who have received nephrectomy and kidney transplantation;
- Those who have suffered from AKI before;
- Those with incomplete medical history or clinical data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with occurrence of acute kidney injury (AKI) after cardiac surgery
Time frame: 48 hours
The definition of the occurrence of acute kidney injury is according to the acute kidney injury (AKI) definition and staging criteria released by Kidney Disease: Improving Global Outcomes (KDIGO) in the year 2012
2 secondary outcomes
Number of participants with occurrence of acute kidney disease (AKD) after cardiac surgery
Time frame: 3 months
Glomerular Filtration Rate(GFR)
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
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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.
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, 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 Xinhua Hospital, Shanghai Jiao Tong 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 4 inclusion and 4 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 12 May 2020. 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?
Number of participants with occurrence of acute kidney injury (AKI) after cardiac surgery (time frame: 48 hours). 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 12 May 2020.