Acute Kidney InjuryAKI-CDSNCT03632538
AKI Cardiosurgery Diagnostic Study (AKI-CDS)
An observational study of Acute Kidney Injury and Renal Replacement Therapy, run by University of Rostock at 1 site in Germany.
Trial summary
Acute kidney injury (AKI) is a common and major complication of cardiac surgery. The aim of this study is to evaluate the use of a fragment of proencephalin in plasma and other biomarkers as specific markers for early diagnosis of AKI and the need of renal replacement therapy after cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Renal Replacement Therapy
- What is being tested?
- Biomarker ("penKid", adrenomedulin, C-terminal alpha-1 antitrypsin peptide)
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 27 Jul 2018to Oct 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 years and older
- All sexes
- Adult, Older adult
Study population: All patients undergoing cardiac surgery and fulfilling the inclusion criteria should be screened for the study at the university hospital of Rostock, Germany at one of the two different intensive care units PIT 1 and 2 at the Department of Anaesthesiology and Intensive Care or at the Department of Cardiac Surgery.
Who may be able to join
- Female or male, at least 18 years old
- Ability to consent to the study by patient or legal representative
- Cardiac surgery with use of extracorporeal circulation (ECC)
- Bypass (> 2; ACB) or bypass + heart valve surgery
- Two or three heart-valve operation
Who cannot join
- Dialysis-dependent patients with chronic, end-stage renal failure
- Pre-existing renal replacement therapy
- Infused prognosis (expected death in ≤ 12 hours despite maximal therapy)
- Inability to consent of participation in the research project, of the patient or of the patients representative
- Aortic surgery
- Endocarditis
- (Only) partial sternotomy (eg. aortic valve surgery)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Intensive Care Units PIT 1+2, University hospital Rostock
Rostock, 18055
Martin Sauer, PD Dr., +49 381 4946434, martin.sauer@uni-rostock.de
Sandra Doß, +49 381 4942640, sandra.doss@med.uni-rostock.de
About this study
Official title: Prospective Analysis of Postoperative Occurrence of Acute Kidney Injury (AKI) and Need for Renal Replacement Therapy After Cardiac Surgery With the Help of New Biomarkers.
Acute kidney injury (AKI) is a common and major complication of cardiac surgery. The aim of this study is to evaluate the use of a fragment of proencephalin in plasma and other biomarkers as specific markers for early diagnosis of AKI and the need of renal replacement therapy after cardiac surgery.
Read the detailed description
Acute kidney injury (AKI) is an abrupt loss of kidney function and occurs in up to 5-40% of patients who undergo cardiac surgery; dialysis being required in approximately 2-15% of all patients. AKI is a common problem in critically ill patients and is independently from underlying diseases associated with increased morbidity and mortality (to progressive loss of kidney function, cardiovascular disease, and death). Unfortunately, chronic kidney disease is often overlooked in its earliest, most treatable stages. Implementation of novel biomarkers into the clinical practice that reliably identify patients at risk or at an early stage of AKI could offer more efficient management strategies may lead to better outcomes in critically ill patients.
Kidney disease usually progresses silently, often destroying most of the kidney function before causing any symptoms. AKI was defined using the Kidney Disease Improvement Global Outcome (KDIGO) definition. The standard key tests (increase of serum creatinine and urine output) are late parameters after significant kidney injury.
In this study 20 female and 20 male adult patients before and after cardiac surgery should be included. From all patients basic demographic data, pre-morbidity, vital parameters, blood parameters, urine output, Illness severity scores (APACHE-II, SOFA, GCS), drug levels, microbiological results will be recorded. The aim of this study is to evaluate the use of a fragment of proencephalin in plasma "penKID", Spingotec GmbH, Berlin, Germany) and other biomarkers (ADM: adrenomedulin, CAAP: C-terminal alpha-1 antitrypsin peptide) as specific markers for early diagnosis of AKI and the need of renal replacement therapy. Bio-ADM is a water-soluble peptide hormone with a molecular weight of about 6kDa released mainly by endothelial cells. Its biological function is the control of vasodilation, an important regulator of blood pressure and organ perfusion. This biomarker predicts and diagnoses endothelial dysfunctions. C-terminal alpha-1 antitrypsin peptide (CAAP) is a novel sepsis and renal injury biomarker with immunomodulatory function, especially in human neutrophils, which supports its role in the host response and pathophysiology of sepsis.
- Conditions
- Acute Kidney Injury, Renal Replacement Therapy
- Being tested
- Biomarker ("penKid", adrenomedulin, C-terminal alpha-1 antitrypsin peptide)
- Keywords
- 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.
Biomarker ("penKid", adrenomedulin, C-terminal alpha-1 antitrypsin peptide)Diagnostic test
Drawing of patients blood for measurement of biomarkers for AKI before and after cardiac surgery (times: 0, 6, 24, 72, 168 hours).
| Study group | Role | What they receive |
|---|---|---|
| Male | 20 male adult patients after cardiac surgery. Drawing of patients blood for measurement of biomarkers ("penKid", adrenomedulin, C-terminal alpha-1 antitrypsin peptide) for AKI before and after cardiac surgery (times: 0, 6, 24, 72, 168 hours). Receives: Diagnostic Test: Biomarker ("penKid", adrenomedulin, C-terminal alpha-1 antitrypsin peptide) | |
| Female | 20 female adult patients after cardiac surgery. Drawing of patients blood for measurement of biomarkers ("penKid", adrenomedulin, C-terminal alpha-1 antitrypsin peptide) for AKI before and after cardiac surgery (times: 0, 6, 24, 72, 168 hours). Receives: Diagnostic Test: Biomarker ("penKid", adrenomedulin, C-terminal alpha-1 antitrypsin peptide) |
What is being measured
The primary outcome is the main question the study is designed to answer.
AKI 0 h
Diagnosis and severity of acute kidney injury following the KDIGO-criteria
Measured: after operation (surgery): 0 hours
AKI 6 h
Diagnosis and severity of acute kidney injury following the KDIGO-criteria
Measured: after operation (surgery): 6 hours
Secondary outcomes (1)
SOFA
SOFA-Score
Measured: before operation, after operation (times: 0, 6, 24, 72 and 168 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start27 Jul 2018
- Primary completionJul 2021 (estimated)
- Study completionOct 2021 (estimated)
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rostock
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Martin Sauer, MD, University of Rostock
- Investigators
- Martin Sauer, MD, Principal investigator, University Medical Center Rostock
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03632538
- Sponsor's protocol ID
- A 2018-0092
- Acronym
- AKI-CDS
- Status last verified
- Apr 2020
- First submitted
- 27 Jul 2018
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Analysis of Postoperative Occurrence of Acute Kidney Injury (AKI) and Need for Renal Replacement Therapy After Cardiac Surgery With the Help of New Biomarkers.
- ClinicalTrials.gov ID
- NCT03632538
- Acronym / sponsor ID
- AKI-CDS / A 2018-0092
- Conditions
- Acute Kidney Injury, Renal Replacement Therapy
- Keywords
- Acute Kidney Injury, Cardiac Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of RostockUniversity, hospital or other
- Study start
- 27 Jul 2018 (actual)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 15 Aug 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.
Acute kidney injury (AKI) is a common and major complication of cardiac surgery. The aim of this study is to evaluate the use of a fragment of proencephalin in plasma and other biomarkers as specific markers for early diagnosis of AKI and the need of renal replacement therapy after cardiac surgery.
Detailed description
Acute kidney injury (AKI) is an abrupt loss of kidney function and occurs in up to 5-40% of patients who undergo cardiac surgery; dialysis being required in approximately 2-15% of all patients. AKI is a common problem in critically ill patients and is independently from underlying diseases associated with increased morbidity and mortality (to progressive loss of kidney function, cardiovascular disease, and death). Unfortunately, chronic kidney disease is often overlooked in its earliest, most treatable stages. Implementation of novel biomarkers into the clinical practice that reliably identify patients at risk or at an early stage of AKI could offer more efficient management strategies may lead to better outcomes in critically ill patients.
Kidney disease usually progresses silently, often destroying most of the kidney function before causing any symptoms. AKI was defined using the Kidney Disease Improvement Global Outcome (KDIGO) definition. The standard key tests (increase of serum creatinine and urine output) are late parameters after significant kidney injury.
In this study 20 female and 20 male adult patients before and after cardiac surgery should be included. From all patients basic demographic data, pre-morbidity, vital parameters, blood parameters, urine output, Illness severity scores (APACHE-II, SOFA, GCS), drug levels, microbiological results will be recorded. The aim of this study is to evaluate the use of a fragment of proencephalin in plasma "penKID", Spingotec GmbH, Berlin, Germany) and other biomarkers (ADM: adrenomedulin, CAAP: C-terminal alpha-1 antitrypsin peptide) as specific markers for early diagnosis of AKI and the need of renal replacement therapy. Bio-ADM is a water-soluble peptide hormone with a molecular weight of about 6kDa released mainly by endothelial cells. Its biological function is the control of vasodilation, an important regulator of blood pressure and organ perfusion. This biomarker predicts and diagnoses endothelial dysfunctions. C-terminal alpha-1 antitrypsin peptide (CAAP) is a novel sepsis and renal injury biomarker with immunomodulatory function, especially in human neutrophils, which supports its role in the host response and pathophysiology of sepsis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Male | – | Diagnostic Test: Biomarker ("penKid", adrenomedulin, C-terminal alpha-1 antitrypsin peptide)20 male adult patients after cardiac surgery. Drawing of patients blood for measurement of biomarkers ("penKid", adrenomedulin, C-terminal alpha-1 antitrypsin peptide) for AKI before and after cardiac surgery (times: 0, 6, 24, 72, 168 hours). |
| Female | – | Diagnostic Test: Biomarker ("penKid", adrenomedulin, C-terminal alpha-1 antitrypsin peptide)20 female adult patients after cardiac surgery. Drawing of patients blood for measurement of biomarkers ("penKid", adrenomedulin, C-terminal alpha-1 antitrypsin peptide) for AKI before and after cardiac surgery (times: 0, 6, 24, 72, 168 hours). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing cardiac surgery and fulfilling the inclusion criteria should be screened for the study at the university hospital of Rostock, Germany at one of the two different intensive care units PIT 1 and 2 at the Department of Anaesthesiology and Intensive Care or at the Department of Cardiac Surgery.
Key inclusion criteria (5 listed)
- Female or male, at least 18 years old
- Ability to consent to the study by patient or legal representative
- Cardiac surgery with use of extracorporeal circulation (ECC)
- Bypass (> 2; ACB) or bypass + heart valve surgery
- Two or three heart-valve operation
Key exclusion criteria (7 listed)
- Dialysis-dependent patients with chronic, end-stage renal failure
- Pre-existing renal replacement therapy
- Infused prognosis (expected death in ≤ 12 hours despite maximal therapy)
- Inability to consent of participation in the research project, of the patient or of the patients representative
- Aortic surgery
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 |
|---|---|---|
| Biomarker ("penKid", adrenomedulin, C-terminal alpha-1 antitrypsin peptide)Drawing of patients blood for measurement of biomarkers for AKI before and after cardiac surgery (times: 0, 6, 24, 72, 168 hours). | Diagnostic test | Female, Male |
Primary outcome
AKI 0 h
Time frame: after operation (surgery): 0 hours
Diagnosis and severity of acute kidney injury following the KDIGO-criteria
AKI 6 h
Time frame: after operation (surgery): 6 hours
Diagnosis and severity of acute kidney injury following the KDIGO-criteria
1 secondary outcome
SOFA
Time frame: before operation, after operation (times: 0, 6, 24, 72 and 168 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
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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.
Martin Sauer, MD principal investigator
University Medical Center Rostock
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 Renal Replacement Therapy, run by University of Rostock at 1 site in Germany.
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 5 inclusion and 7 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 7 Apr 2020. 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 Germany. 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?
Contact Martin Sauer, MD (+493814946409, martin.sauer@uni-rostock.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AKI 0 h (time frame: after operation (surgery): 0 hours). 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 7 Apr 2020.