PathogenesisNCT03557047
Perioperative Mechanism of Acute Kidney Injury in Cardiovascular Surgery
An observational study of Pathogenesis and Acute Kidney Injury, run by The First Affiliated Hospital of Anhui Medical University at 1 site in China.
Trial summary
Continuous observation of acute renal injury after cardiac surgery, at the same time retention of blood samples, to test indicators，and to select the research route from the clinical actual test results . Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pathogenesis, Acute Kidney Injury, Cardiac Surgery
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 8 Mar 2018to Sep 2021
- How long will I take part?
- 1 Week
- 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: Perioperative data were collected, including cardiopulmonary bypass time，aortic cross-clamping time, operative time, extubation time, ICU time and hospital stay.
Who may be able to join
- Adult patients undergoing selective cardiac surgery, aged between 18 and 80.
Who cannot join
- Normal range of creatinine before operation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022
Qian Gong, (086)13485690649, 54xiaoqian@sina.com
About this study
Official title: Preliminary Study on the Pathogenesis of Acute Kidney Injury After Cardiac Surgery
Continuous observation of acute renal injury after cardiac surgery, at the same time retention of blood samples, to test indicators，and to select the research route from the clinical actual test results .
- Conditions
- Pathogenesis, Acute Kidney Injury, Cardiac Surgery
- Medical subject headings
- Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute renal injury after cardiac surgery
The standard of acute renal injury is based on the KDIGO
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start8 Mar 2018
- Primary completionMar 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PathogenesisStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03557047
- Sponsor's protocol ID
- PJ2018-03-10
- Status last verified
- Mar 2018
- First submitted
- 3 Jun 2018
- Last updated
- 3 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Study on the Pathogenesis of Acute Kidney Injury After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03557047
- Acronym / sponsor ID
- PJ2018-03-10
- Conditions
- Pathogenesis, Acute Kidney Injury, Cardiac Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Anhui Medical UniversityUniversity, hospital or other
- Study start
- 8 Mar 2018 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 14 Jun 2018 (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.
Continuous observation of acute renal injury after cardiac surgery, at the same time retention of blood samples, to test indicators，and to select the research route from the clinical actual test results .
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Week
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Perioperative data were collected, including cardiopulmonary bypass time，aortic cross-clamping time, operative time, extubation time, ICU time and hospital stay.
Key inclusion criteria (1 listed)
- Adult patients undergoing selective cardiac surgery, aged between 18 and 80.
Key exclusion criteria (1 listed)
- Normal range of creatinine before operation
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
Incidence of acute renal injury after cardiac surgery
Time frame: 48 hours
The standard of acute renal injury is based on the KDIGO
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
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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.
The First Affiliated Hospital of Anhui Medical University
Hefei, 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 Pathogenesis and Acute Kidney Injury, run by The First Affiliated Hospital of Anhui 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 1 inclusion and 1 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 3 Jul 2018. 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?
Incidence of acute renal injury 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 3 Jul 2018.