Cardiac Surgery Associated - Acute Kidney InjuryTransAKINCT06730854
Association Between Liver Function Tests and Acute Kidney Injury in Cardiac Surgery Patients
An observational study of Cardiac Surgery Associated - Acute Kidney Injury and Acute Kidney Injury, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
A sudden decline in function of the kidneys is a common problem that can happen after heart surgery. It can have serious effects on a patient's recovery and long-term health, potentially leading to permanent kidney problems or heart-related issues. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery Associated - Acute Kidney Injury, Acute Kidney Injury
- How many people
- 3,415 participants
- Where
- 1 siteBelgium
- Study dates
- 6 Nov 2024to 6 Nov 2024
- 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: The cardiac surgery patients screened for eligibility were admitted on the cardiac surgery intensive care unit of Ghent University hospital between 1 Januari 2012 until 31 december 2017
Who may be able to join
- 18 years old or older
- admission on intensive care after cardiac surgery
- available data about liver enzymes
Who cannot join
- chronic kidney disease with (estimated) glomerular filtration rate below 30mL/min/1.73 m2 or renal replacement therapy (RRT) dependent
- patient on extracorporal membrane oxygenator (ECMO) before or after cardiac surgery
- patient with or planned surgery for Left ventricular assist device (LVAD)
- inotropics or vasopressore before surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Elevated Liver Functions Tests Following Cardiac Surgery and Acute Kidney Injury - a Restrospectiv Single Center Cohort Study
A sudden decline in function of the kidneys is a common problem that can happen after heart surgery. It can have serious effects on a patient's recovery and long-term health, potentially leading to permanent kidney problems or heart-related issues. One of the main reasons kidney problems occurs is due to changes in blood flow caused by the heart not pumping well enough. These changes may harm the kidneys, but other organs as well such as the liver.
This study aims to find out if there is a relationship between elevated levels of liver function blood tests and the decline in kidney function.
Read the detailed description
In this study data will be retrospectively collected from the intensive care patient management system for patients admitted postoperatively to the cardiac intensive care unit (ICU) following cardiac surgery. The inclusion period spans from 2012 to 2017 (5 years) and includes about 3,500 patients.
For all included patients, retrospective data collection will include variables related to renal function, fluid balance, hemodynamics, and transaminase levels. Additionally, demographic information, surgical procedure details, comorbidities, and laboratory values will be gathered.
Cardiac surgery-associated acute kidney injury (CSA-AKI) has a multifactorial etiology influenced by non-modifiable factors such as age, comorbidities (e.g., heart failure/ejection fraction, chronic kidney disease, hypertension, diabetes), medication use (NSAIDs, ACE inhibitors/ARBs), type of surgery, duration of surgery/cardiopulmonary bypass time. Central venous pressure (CVP) can serve as a marker of venous congestion, which may contribute to the development of AKI. Venous congestion may also result in elevated transaminase levels.
The primary aim of this study is to investigate the association between postoperative transaminase elevation in the ICU and the development of AKI during the intensive care stay. Data about transaminases will be collected in the first 24 hours after ICU admission. The occurrence of AKI and its severity will be investigated within 72 hours after cardiac surgery. Furthermore, the relationship between the transaminase elevation and the severity of acute kidney injury will be examined, as well as the association between central venous presure (CVP) and transaminase levels postoperatively in the ICU.
Acute kidney injury will be defined according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria, with severity classified based on the KDIGO staging system.
- Keywords
- liver enzymes, acute kidney injury, cardiac surgery
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Main cohort of patient | In the included patients the occurrence of acute kidney injury (AKI) will be investigated. So patient will be grouped as 'no AKI' and 'AKI' For the subanalysis, patient will be grouped according to their admission central venous pressure. There are no interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between liver enzymes and acute kidney injury
Investigation of the association between liver enzymes (alanine aminotransferase (AST); aspartate aminotransferase (ALT)) and development of acute kidney injury. Data about liver enzymes will be collected at ICU admission, and 12 hours and 24 hours after ICU admission. AKI is defined by the Kidney Disease Improving global outcome definition by using both the serum creatinine and urine output criteria.
Measured: Data about liver enzymes will be collected at ICU admission, and 12 hours and 24 hours after ICU admission. The occurrence of acute kidney injury within 72 hours after ICU admission will be investigated
Secondary outcomes (2)
Association between liver enzymes and the severity of acute kidney injury
Investigation of the association between liver enzymes (alanine aminotransferase (AST); aspartate aminotransferase (ALT)) and the sevirity of the developed acute kidney injury. AKI severity is defined by the Kidney Disease Improving global outcome (KDIGO) classification: stage 1, stage 2 and stage 3. Stage 3 is the most severe form of kidney injury, including the use of renal replacement therapy (RRT)
Measured: Data about liver enzymes will be collected at ICU admission, and 12 hours and 24 hours after ICU admission. The occurrence of the different severity stages of acute kidney injury within 72 hours after ICU admission will be investigated
association of central venous pressure with elevated liver enzymes and acute kidney injury
Investigation of the association between elevated central venous pressure and elevation in liver enzymes (alanine aminotransferase (AST); aspartate aminotransferase (ALT)) and the development of acute kidney injury (severity)
Measured: Data about central venous pressure will be collected during the first 24 hours after ICU admission.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start6 Nov 2024
- Primary completion6 Nov 2024
- Study completion6 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Surgery Associated - 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
- Retrospective
- Enrolment
- 3,415 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wim Vandenberghe, MD; PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06730854
- Sponsor's protocol ID
- ONZ-2024-0453
- Acronym
- TransAKI
- Status last verified
- Nov 2024
- First submitted
- 26 Nov 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to European Data Protection regulation, no individual participant data will be shared, only the analysed data.
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Elevated Liver Functions Tests Following Cardiac Surgery and Acute Kidney Injury - a Restrospectiv Single Center Cohort Study
- ClinicalTrials.gov ID
- NCT06730854
- Acronym / sponsor ID
- TransAKI / ONZ-2024-0453
- Keywords
- liver enzymes, acute kidney injury, cardiac surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,415 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 6 Nov 2024 (actual)
- Primary completion
- 6 Nov 2024 (actual)
- Study completion
- 6 Nov 2024 (actual)
- First posted
- 12 Dec 2024 (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.
A sudden decline in function of the kidneys is a common problem that can happen after heart surgery. It can have serious effects on a patient's recovery and long-term health, potentially leading to permanent kidney problems or heart-related issues. One of the main reasons kidney problems occurs is due to changes in blood flow caused by the heart not pumping well enough. These changes may harm the kidneys, but other organs as well such as the liver.
This study aims to find out if there is a relationship between elevated levels of liver function blood tests and the decline in kidney function.
Detailed description
In this study data will be retrospectively collected from the intensive care patient management system for patients admitted postoperatively to the cardiac intensive care unit (ICU) following cardiac surgery. The inclusion period spans from 2012 to 2017 (5 years) and includes about 3,500 patients.
For all included patients, retrospective data collection will include variables related to renal function, fluid balance, hemodynamics, and transaminase levels. Additionally, demographic information, surgical procedure details, comorbidities, and laboratory values will be gathered.
Cardiac surgery-associated acute kidney injury (CSA-AKI) has a multifactorial etiology influenced by non-modifiable factors such as age, comorbidities (e.g., heart failure/ejection fraction, chronic kidney disease, hypertension, diabetes), medication use (NSAIDs, ACE inhibitors/ARBs), type of surgery, duration of surgery/cardiopulmonary bypass time. Central venous pressure (CVP) can serve as a marker of venous congestion, which may contribute to the development of AKI. Venous congestion may also result in elevated transaminase levels.
The primary aim of this study is to investigate the association between postoperative transaminase elevation in the ICU and the development of AKI during the intensive care stay. Data about transaminases will be collected in the first 24 hours after ICU admission. The occurrence of AKI and its severity will be investigated within 72 hours after cardiac surgery. Furthermore, the relationship between the transaminase elevation and the severity of acute kidney injury will be examined, as well as the association between central venous presure (CVP) and transaminase levels postoperatively in the ICU.
Acute kidney injury will be defined according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria, with severity classified based on the KDIGO staging system.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main cohort of patient | – | –In the included patients the occurrence of acute kidney injury (AKI) will be investigated. So patient will be grouped as 'no AKI' and 'AKI' For the subanalysis, patient will be grouped according to their admission central venous pressure. There are no interventions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The cardiac surgery patients screened for eligibility were admitted on the cardiac surgery intensive care unit of Ghent University hospital between 1 Januari 2012 until 31 december 2017
Key inclusion criteria (3 listed)
- 18 years old or older
- admission on intensive care after cardiac surgery
- available data about liver enzymes
Key exclusion criteria (4 listed)
- chronic kidney disease with (estimated) glomerular filtration rate below 30mL/min/1.73 m2 or renal replacement therapy (RRT) dependent
- patient on extracorporal membrane oxygenator (ECMO) before or after cardiac surgery
- patient with or planned surgery for Left ventricular assist device (LVAD)
- inotropics or vasopressore before surgery
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
Association between liver enzymes and acute kidney injury
Time frame: Data about liver enzymes will be collected at ICU admission, and 12 hours and 24 hours after ICU admission. The occurrence of acute kidney injury within 72 hours after ICU admission will be investigated
Investigation of the association between liver enzymes (alanine aminotransferase (AST); aspartate aminotransferase (ALT)) and development of acute kidney injury. Data about liver enzymes will be collected at ICU admission, and 12 hours and 24 hours after ICU admission. AKI is defined by the Kidney Disease Improving global outcome definition by using both the serum creatinine and urine output criteria.
2 secondary outcomes
Association between liver enzymes and the severity of acute kidney injury
Time frame: Data about liver enzymes will be collected at ICU admission, and 12 hours and 24 hours after ICU admission. The occurrence of the different severity stages of acute kidney injury within 72 hours after ICU admission will be investigated
association of central venous pressure with elevated liver enzymes and acute kidney injury
Time frame: Data about central venous pressure will be collected during the first 24 hours after ICU admission.
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 12 Dec 2024.
- Individual participant dataSharing planned: No. Due to European Data Protection regulation, no individual participant data will be shared, only the analysed data.
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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.
Wim Vandenberghe, MD; PhD principal investigator
University Hospital, Ghent
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 Cardiac Surgery Associated - Acute Kidney Injury and Acute Kidney Injury, run by University Hospital, Ghent at 1 site in Belgium.
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 3 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: finished, as of the sponsor's last update on 12 Dec 2024. 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 Belgium. 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?
Association between liver enzymes and acute kidney injury (time frame: Data about liver enzymes will be collected at ICU admission, and 12 hours and 24 hours after ICU admission. The occurrence of acute kidney injury within 72 hours after ICU admission will be investigated). 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 Dec 2024.