Acute Kidney InjuryNCT05386940
Protein Kinase N1 Level in Patients Undergoing Cardiac Surgery
An observational study of Acute Kidney Injury and Extracorporeal Circulation; Complications, run by Zhongnan Hospital at 1 site in China.
Trial summary
Acute kidney injury (AKI) is one of the most frequent major complications in patients undergoing cardiac surgery. CSA-AKI is independently related to increased perioperative mortality, increased hospital and ICU length of stay as well as heath care expenditure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Extracorporeal Circulation; Complications, Surgery
- What is being tested?
- PKN1 level
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 22 Jul 2019to 14 Mar 2021
- How long will I take part?
- 2 Weeks
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients (≥18 years old) underwent on-pump cardiac surgery and admitted to ICU immediately after surgery
Who may be able to join
- Patients (≥18 years old) underwent on-pump cardiac surgery
- admitted to ICU immediately after surgery
Who cannot join
- Patients younger than 18 years
- with prior AKI
- end-stage kidney disease
- need for chronic hemodialysis
- pregnant patients
- unable to give written consent for participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Protein Kinase N1 Level Predicts Acute Kidney Injury in Patients Undergoing Cardiac Surgery
Acute kidney injury (AKI) is one of the most frequent major complications in patients undergoing cardiac surgery. CSA-AKI is independently related to increased perioperative mortality, increased hospital and ICU length of stay as well as heath care expenditure. Identification of relevant biomarkers may lead to early diagnosis and improve patient outcomes and health care costs. The pathophysiology of CSA-AKI is complex and ischemia-reperfusion injury is one of the important factors. Recently, it has been shown that Protein kinase N1 (PKN1) is associated with ischemia-reperfusion injury. In this study, relationship between PKN1 with the risk of CSA-AKI was analyzed and the predictive value of elevated level of PKN1 for early prediction of CSA-AKI was further evaluated.
Read the detailed description
Acute kidney injury (AKI) is one of the most frequent major complications in patients undergoing cardiac surgery. The incidence of cardiac surgery-associated AKI (CSA-AKI) varies from 5% to 42% and is the second leading cause of AKI (after sepsis) in the intensive care unit (ICU). CSA-AKI is independently related to increased perioperative mortality, increased hospital and ICU length of stay as well as heath care expenditure. Early detection of CSA-AKI could improve patient outcomes and health care costs through targeted interventions. Thus, identification of relevant biomarkers may lead to early diagnosis. The pathophysiology of CSA-AKI is complex and ischemia-reperfusion injury is one of the important factors. Recently, it has been shown that Protein kinase N1 (PKN1) is associated with ischemia-reperfusion injury. Nowadays, little is known about relationship between PKN1 and CSA-AKI. In this study, relationship between PKN1 with the risk of CSA-AKI was analyzed and the predictive value of elevated level of PKN1 for early prediction of CSA-AKI was further evaluated.
- Being tested
- PKN1 level
- 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.
PKN1 levelOther
different PKN1 level after on-pump cardiac surgery
| Study group | Role | What they receive |
|---|---|---|
| PKN1 Tertile 1 | Not described Receives: Other: PKN1 level | |
| PKN1 Tertile 2 | Not described Receives: Other: PKN1 level | |
| PKN1 Tertile 3 | Not described Receives: Other: PKN1 level |
What is being measured
The primary outcome is the main question the study is designed to answer.
the development of CSA-AKI
the development of CSA-AKI
Measured: 1 Week
Secondary outcomes (5)
AKI severity
AKI stage 1，stage 2，stage 3
Measured: 1 Week
need for RRT
Reflect kidney function
Measured: 1 Week
duration of AKI (≥7 days)
Reflect kidney function
Measured: 1 Week
length of ICU stay
Reflect patient prognosis
Measured: up to 28 days
post-operative hospital stay
Reflect patient prognosis
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start22 Jul 2019
- Primary completion14 Mar 2021
- Study completion14 Mar 2021
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.
- 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
- 110 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ZhiYong Peng, Study director, Department of Critical Care Medicine, Zhongnan Hospital of Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05386940
- Sponsor's protocol ID
- 2017004
- Status last verified
- Jan 2022
- First submitted
- 15 May 2022
- Last updated
- 23 May 2022
- 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 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protein Kinase N1 Level Predicts Acute Kidney Injury in Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05386940
- Acronym / sponsor ID
- 2017004
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Study start
- 22 Jul 2019 (actual)
- Primary completion
- 14 Mar 2021 (actual)
- Study completion
- 14 Mar 2021 (actual)
- First posted
- 23 May 2022 (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.
Acute kidney injury (AKI) is one of the most frequent major complications in patients undergoing cardiac surgery. CSA-AKI is independently related to increased perioperative mortality, increased hospital and ICU length of stay as well as heath care expenditure. Identification of relevant biomarkers may lead to early diagnosis and improve patient outcomes and health care costs. The pathophysiology of CSA-AKI is complex and ischemia-reperfusion injury is one of the important factors. Recently, it has been shown that Protein kinase N1 (PKN1) is associated with ischemia-reperfusion injury. In this study, relationship between PKN1 with the risk of CSA-AKI was analyzed and the predictive value of elevated level of PKN1 for early prediction of CSA-AKI was further evaluated.
Detailed description
Acute kidney injury (AKI) is one of the most frequent major complications in patients undergoing cardiac surgery. The incidence of cardiac surgery-associated AKI (CSA-AKI) varies from 5% to 42% and is the second leading cause of AKI (after sepsis) in the intensive care unit (ICU). CSA-AKI is independently related to increased perioperative mortality, increased hospital and ICU length of stay as well as heath care expenditure. Early detection of CSA-AKI could improve patient outcomes and health care costs through targeted interventions. Thus, identification of relevant biomarkers may lead to early diagnosis. The pathophysiology of CSA-AKI is complex and ischemia-reperfusion injury is one of the important factors. Recently, it has been shown that Protein kinase N1 (PKN1) is associated with ischemia-reperfusion injury. Nowadays, little is known about relationship between PKN1 and CSA-AKI. In this study, relationship between PKN1 with the risk of CSA-AKI was analyzed and the predictive value of elevated level of PKN1 for early prediction of CSA-AKI was further evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PKN1 Tertile 1 | – | Other: PKN1 level |
| PKN1 Tertile 2 | – | Other: PKN1 level |
| PKN1 Tertile 3 | – | Other: PKN1 level |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients (≥18 years old) underwent on-pump cardiac surgery and admitted to ICU immediately after surgery
Key inclusion criteria (2 listed)
- Patients (≥18 years old) underwent on-pump cardiac surgery
- admitted to ICU immediately after surgery
Key exclusion criteria (6 listed)
- Patients younger than 18 years
- with prior AKI
- end-stage kidney disease
- need for chronic hemodialysis
- pregnant patients
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 |
|---|---|---|
| PKN1 leveldifferent PKN1 level after on-pump cardiac surgery | Other | PKN1 Tertile 1, PKN1 Tertile 2, PKN1 Tertile 3 |
Primary outcome
the development of CSA-AKI
Time frame: 1 Week
the development of CSA-AKI
5 secondary outcomes
AKI severity
Time frame: 1 Week
need for RRT
Time frame: 1 Week
duration of AKI (≥7 days)
Time frame: 1 Week
length of ICU stay
Time frame: up to 28 days
post-operative hospital stay
Time frame: up to 28 days
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 23 May 2022.
- Individual participant dataSharing planned: No
Related trials for Acute Kidney Injury
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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.
ZhiYong Peng study director
Department of Critical Care Medicine, Zhongnan Hospital of Wuhan 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 Acute Kidney Injury and Extracorporeal Circulation; Complications, run by Zhongnan Hospital 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 6 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 23 May 2022. 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?
the development of CSA-AKI (time frame: 1 Week). 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 2022.