Aortic DissectionNCT05039814
Prediction of Postoperative Acute Kidney Injury in Patients With Acute Type A Aortic Dissection Using Cystatin C
An observational study of Aortic Dissection and Acute Kidney Injury, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
The research aimed to predict postoperative acute kidney injury in patients with acute type A aortic dissection preliminarily by exploring the correlation of preoperative cystatin C level and incidence of postoperative acute kidney injury and combining with relevant risk factors. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aortic Dissection, Acute Kidney Injury
- What is being tested?
- postoperative acute kidney injury and none postoperative acute kidney injury
- How many people
- 249 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2020to 15 Aug 2021
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients sufferred acute type A aortic dissection
Who may be able to join
- 18-80 years old
- Acute type A aortic dissection diagnosed by CT angiography
Who cannot join
- History of chronic kidney disease
- History of cardiovascular operation
- Pregnancy status
Trial locations and contacts
1 site in 1 country.
About this study
The research aimed to predict postoperative acute kidney injury in patients with acute type A aortic dissection preliminarily by exploring the correlation of preoperative cystatin C level and incidence of postoperative acute kidney injury and combining with relevant risk factors.
- Conditions
- Aortic Dissection, Acute Kidney Injury
- Being tested
- postoperative acute kidney injury, none postoperative acute kidney injury
- Medical subject headings
- Aortic Dissection, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
postoperative acute kidney injuryOther
patients suffered postoperative acute kidney injury
none postoperative acute kidney injuryOther
patients did not suffered postoperative acute kidney injury
| Study group | Role | What they receive |
|---|---|---|
| AKI | patients suffered postoperative acute kidney injury Receives: Other: postoperative acute kidney injury | |
| Non-AKI | patients did not suffer postoperative acute kidney injury Receives: Other: none postoperative acute kidney injury |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative acute kidney injury
YES; NO
Measured: From date of operation until the date of acute kidney injury or date of death from any cause, 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 posted10 Sep 2021
- Study start1 Oct 2020
- Primary completion1 Jun 2021
- Study completion15 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic DissectionStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xin Zhao, Principal investigator, Department of cardiac surgery, Qilu Hospital, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05039814
- Sponsor's protocol ID
- 81500367
- Status last verified
- Aug 2021
- First submitted
- 1 Sep 2021
- Last updated
- 3 Aug 2023
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Postoperative Acute Kidney Injury in Patients With Acute Type A Aortic Dissection Using Cystatin C
- ClinicalTrials.gov ID
- NCT05039814
- Acronym / sponsor ID
- 81500367
- Conditions
- Aortic Dissection, Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 15 Aug 2021 (actual)
- First posted
- 10 Sep 2021 (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 research aimed to predict postoperative acute kidney injury in patients with acute type A aortic dissection preliminarily by exploring the correlation of preoperative cystatin C level and incidence of postoperative acute kidney injury and combining with relevant risk factors.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AKI | – | Other: postoperative acute kidney injurypatients suffered postoperative acute kidney injury |
| Non-AKI | – | Other: none postoperative acute kidney injurypatients did not suffer postoperative acute kidney injury |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients sufferred acute type A aortic dissection
Key inclusion criteria (2 listed)
- 18-80 years old
- Acute type A aortic dissection diagnosed by CT angiography
Key exclusion criteria (3 listed)
- History of chronic kidney disease
- History of cardiovascular operation
- Pregnancy status
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 |
|---|---|---|
| postoperative acute kidney injurypatients suffered postoperative acute kidney injury | Other | AKI |
| none postoperative acute kidney injurypatients did not suffered postoperative acute kidney injury | Other | Non-AKI |
Primary outcome
postoperative acute kidney injury
Time frame: From date of operation until the date of acute kidney injury or date of death from any cause, whichever came first, assessed up to 30 days.
YES; NO
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 3 Aug 2023.
- Individual participant dataSharing planned: Undecided
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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.
Xin Zhao principal investigator
Department of cardiac surgery, Qilu Hospital, Shandong 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 Aortic Dissection and Acute Kidney Injury, run by Qilu Hospital of Shandong 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: finished, as of the sponsor's last update on 3 Aug 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?
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?
postoperative acute kidney injury (time frame: From date of operation until the date of acute kidney injury or date of death from any cause, 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 3 Aug 2023.