Acute Kidney InjuryNCT03860545
New Markers of Cardiac Surgery Related Acute Kidney Injury.
An observational study of Acute Kidney Injury and Cardiac Disease, run by Pomeranian Medical University Szczecin at 1 site in Poland.
Trial summary
Cardiac surgery related acute kidney injury (CS-AKI) is a clinical problem associated with a cardiopulmonary bypass used during cardiac surgery procedures. In this study the investigators will assess the biochemical markers of acute kidney injury such as ischemia modified albumin (IMA) or urinary excreted of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Cardiac Disease
- What is being tested?
- urine and blood analysis
- How many people
- 88 participants
- Where
- 1 sitePoland
- Study dates
- 2 Jan 2018to 26 Feb 2019
- 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 study population will be divided into 2 groups regarding postoperative acute kidney injury
Who may be able to join
- a planned operation of coronary artery bypass grafting with the use of cardiopulmonary bypass
Who cannot join
- emergency operations or re-operations;
- a known pathology of the urinary tract or renal failure;
- chronic use of the following medications: iron, non-steroidal anti-inflammatory drugs (NSAIDs), immunosuppression, or steroids in the preoperative period;
- polycythemia, porphyria or pathological hemoglobin species in anamnesis;
- preoperative signs of hepatic failure;
- active autoimmune or neoplastic diseases, active infection;
- anticipated significant bleeding (anti-platelet agents), suggesting the use of blood-derived products during the operation and afterward
- acute myocardial infarction after operation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The New Biochemical Markers of Cardiac Surgery Related Acute Kidney Injury.
Cardiac surgery related acute kidney injury (CS-AKI) is a clinical problem associated with a cardiopulmonary bypass used during cardiac surgery procedures. In this study the investigators will assess the biochemical markers of acute kidney injury such as ischemia modified albumin (IMA) or urinary excreted of brush-border enzymes of the proximal renal tubules perioperatively. There has been no official recommendations toward routine use of analysed biomarkers.
Read the detailed description
Cardiac surgery related acute kidney injury (CS-AKI) is an important clinical problem. Kidney injury occurs following a cardiopulmonary bypass used during cardiac surgery procedures. The pathomechanisms of acute kidney injury (AKI) is complex and multifactorial. It may involve few injury pathways: ischemia and reperfusion, endogenous toxins, inflammation, metabolic factors and oxidative stress. Biochemical markers of acute kidney injury such as ischemia modified albumin (IMA) or urinary excreted of brush-border enzymes of the proximal renal tubules analysed perioperatively will be assessed in this study. There has been no official recommendations toward routine use of analysed biomarkers.
- Conditions
- Acute Kidney Injury, Cardiac Disease
- Being tested
- urine and blood analysis
- Keywords
- Acute Kidney Injury, cardiopulmonary bypass, brush-border enzymes of the proximal renal tubules, ischemia modified albumin
- Medical subject headings
- Acute Kidney Injury, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urine and blood analysisDiagnostic test
concentration of ischemia modified albumin assessed in blood before operation, immediately and one hour after cardiopulmonary bypass, 24 hours after operation; concentration of urinary excretion of brush-border enzymes of the proximal renal tubules assessed before operation, immediately and one hour after cardiopulmonary bypass, 24 hours after operation, serum creatinine levels will be evaluated on the day of the operation and 24 h and 48 h postoperatively
| Study group | Role | What they receive |
|---|---|---|
| non-AKI | patient without acute kidney injury (AKI) during perioperative observation period Receives: Diagnostic Test: urine and blood analysis | |
| AKI | patient with diagnosis acute kidney injury (AKI) established during perioperative observation period Receives: Diagnostic Test: urine and blood analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
acute kidney injure after operation
acute kidney injure measured by creatinine concentration mg/dl
Measured: up to 48 hours post operation
acute kidney injure after operation
acute kidney injure measured by urine output in ml
Measured: up to 48 hours post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study start2 Jan 2018
- Primary completion26 Feb 2019
- Study completion26 Feb 2019
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
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pomeranian Medical University Szczecin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jowita Biernawska, Pomeranian Medical University Szczecin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03860545
- Sponsor's protocol ID
- KB - 0012/146/10
- Status last verified
- Feb 2019
- First submitted
- 26 Feb 2019
- Last updated
- 4 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: encoded in database of principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The New Biochemical Markers of Cardiac Surgery Related Acute Kidney Injury.
- ClinicalTrials.gov ID
- NCT03860545
- Acronym / sponsor ID
- KB - 0012/146/10
- Conditions
- Acute Kidney Injury, Cardiac Disease
- Keywords
- Acute Kidney Injury, cardiopulmonary bypass, brush-border enzymes of the proximal renal tubules, ischemia modified albumin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Pomeranian Medical University SzczecinUniversity, hospital or other
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 26 Feb 2019 (actual)
- Study completion
- 26 Feb 2019 (actual)
- First posted
- 4 Mar 2019 (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.
Cardiac surgery related acute kidney injury (CS-AKI) is a clinical problem associated with a cardiopulmonary bypass used during cardiac surgery procedures. In this study the investigators will assess the biochemical markers of acute kidney injury such as ischemia modified albumin (IMA) or urinary excreted of brush-border enzymes of the proximal renal tubules perioperatively. There has been no official recommendations toward routine use of analysed biomarkers.
Detailed description
Cardiac surgery related acute kidney injury (CS-AKI) is an important clinical problem. Kidney injury occurs following a cardiopulmonary bypass used during cardiac surgery procedures. The pathomechanisms of acute kidney injury (AKI) is complex and multifactorial. It may involve few injury pathways: ischemia and reperfusion, endogenous toxins, inflammation, metabolic factors and oxidative stress. Biochemical markers of acute kidney injury such as ischemia modified albumin (IMA) or urinary excreted of brush-border enzymes of the proximal renal tubules analysed perioperatively will be assessed in this study. There has been no official recommendations toward routine use of analysed biomarkers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-AKI | – | Diagnostic Test: urine and blood analysispatient without acute kidney injury (AKI) during perioperative observation period |
| AKI | – | Diagnostic Test: urine and blood analysispatient with diagnosis acute kidney injury (AKI) established during perioperative observation period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be divided into 2 groups regarding postoperative acute kidney injury
Key inclusion criteria (1 listed)
- a planned operation of coronary artery bypass grafting with the use of cardiopulmonary bypass
Key exclusion criteria (8 listed)
- emergency operations or re-operations;
- a known pathology of the urinary tract or renal failure;
- chronic use of the following medications: iron, non-steroidal anti-inflammatory drugs (NSAIDs), immunosuppression, or steroids in the preoperative period;
- polycythemia, porphyria or pathological hemoglobin species in anamnesis;
- preoperative signs of hepatic failure;
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 |
|---|---|---|
| urine and blood analysisconcentration of ischemia modified albumin assessed in blood before operation, immediately and one hour after cardiopulmonary bypass, 24 hours after operation; concentration of urinary excretion of brush-border enzymes of the proximal renal tubules assessed before operation, immediately and one hour after cardiopulmonary bypass, 24 hours after operation, serum creatinine levels will be evaluated on the day of the operation and 24 h and 48 h postoperatively | Diagnostic test | AKI, non-AKI |
Primary outcome
acute kidney injure after operation
Time frame: up to 48 hours post operation
acute kidney injure measured by creatinine concentration mg/dl
acute kidney injure after operation
Time frame: up to 48 hours post operation
acute kidney injure measured by urine output in ml
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 4 Mar 2019.
- Individual participant dataSharing planned: Undecided. encoded in database of principal investigator
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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 record lists no contact. Use the official record to reach the sponsor.
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 Cardiac Disease, run by Pomeranian Medical University Szczecin at 1 site in Poland.
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 8 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 4 Mar 2019. 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 Poland. 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?
acute kidney injure after operation (time frame: up to 48 hours post operation). The study lists 2 primary outcomes in all. 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 4 Mar 2019.