Consecutive Incident Adult Patients Undergoing Elective Cardiac SurgeryNCT01876134
The Diagnostic Role of Cystein-rich Protein 61 (Cyr61) in Acute Kidney Injury: Correlation With the Harmonic Analysis of Arterial Pressure Pulse Waves.
An observational study of Consecutive Incident Adult Patients Undergoing Elective Cardiac Surgery, run by National Taiwan University Hospital.
Trial summary
Acute kidney injury (AKI) is a common heterogeneous disease that complicates several medical and surgical conditions. Recent studies have demonstrated that the occurrence of AKI significantly increase the risk of adverse outcomes. Despite the advanced in modern medicine, the interventions for AKI are not improved. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Consecutive Incident Adult Patients Undergoing Elective Cardiac Surgery
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to Jun 2014
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive incident adult patients undergoing elective cardiac surgery (including coronary artery bypass graft, valve surgery, and correction of congenital heart diseases)
Who may be able to join
- All consecutive incident adult patients undergoing elective cardiac surgery (including coronary artery bypass graft, valve surgery, and correction of congenital heart diseases)
Who cannot join
- age younger than 20 years or older than 80 years; pregnant woman; emergent cardiac surgery; use of intra-aortic balloon pump or extracorporeal membrane oxygenation after surgery, pre-existing severe renal insufficiency (defined as estimated glomerular filtration rate 15 cc/min or less by the Modification of Diet in Renal Disease study equation36); patients with end-stage renal disease under maintenance hemodialysis, peritoneal dialysis, or receiving kidney transplantation; use of radiocontrast ≤24 h prior to the surgery; use of nephrotoxic drugs before or during the surgery
About this study
Acute kidney injury (AKI) is a common heterogeneous disease that complicates several medical and surgical conditions. Recent studies have demonstrated that the occurrence of AKI significantly increase the risk of adverse outcomes. Despite the advanced in modern medicine, the interventions for AKI are not improved. One major reason of the failure to shift therapeutic progress is the clinicians' widespread dependence upon serum creatinine, an unreliable marker during acute changes of renal function, for the diagnosis of AKI.
In the past decade, over 20 unique biomarkers of AKI had been explored. Among them, neutrophil gelatinase-associated lipocalin (NGAL), interleukin-18 (IL-18), and kidney injury molecule-1 (KIM-1) have received the most interest. None of them, however, is an idea one.
Read more
Cysteine-rich protein 61 (Cyr61), a secreted matrix-associated heparin-binding protein, belongs to the "CCN" family. It regulates a broad spectrum of cellular activities, including cell adhesion, migration, proliferation, survival, differentiation, apoptosis, angiogenesis, and extracellular matrix production of multiple cell types. By the kidney ischemic/reperfusion injury animal model, Cyr61 gene was found to be rapidly up-regulated in the renal outer medulla. That portion of the kidney is corresponding to the area of marginally oxygenated under normal condition and most tubular injury following renal ischemic/reperfusion injury.18 Elevation of Cyr61 protein was detected in the kidney and also in urine following injury, making it a potential marker of AKI.
Additionally, pulse diagnosis is an integrative part of traditional Chinese medicine. With spectral analysis of the pulse waves, researchers started to observe the pulse wave harmonics. An in vivo study of rats revealed that ligating one or both of the renal arteries significantly reduced the second harmonic component of the pressure pulse at the caudate artery. Ligating the artery toward the spleen prominently reduced the third harmonics component of the pulse. Analysis of the harmonics in the spectrum of the arterial pressure wave revealed that individual organs might have their own natural frequencies. These observations suggested that individual vascular beds exert independent, frequency-specific, effects on the peripheral pressure wave.
Among different etiologies, cardiac surgery is an important cause of AKI. It has been shown that AKI after cardiac surgery is relatively highly prevalent and prognostically important. Cardiac surgery is usually performed with the use of extracorporeal cardiopulmonary bypass machine ('on-pump').
Based on the evidence from cell culture study and animal study in the literature, we hypothesize that Cyr61 is rapidly increased in the urine after AKI. We thus design this project to evaluate study the diagnostic role and clinical application of Cyr61 in AKI. We will conduct a prospective cohort study to evaluate the changes of urinary Cyr61 in patients undergoing cardiac surgery. Cyr61 may serve a good biomarker for the early diagnosis of patients with AKI, either singly or in combination with NGAL. By the way, we also try to correlate the changes in those biomarker with a potential new tool：harmonic analysis of arterial pressure pulse waves. We have special interest in following the time course of changes in biomarker and correlate with changes in pulse analysis. Physiological parameters of vascular compliance and regional blood oxygen saturation will be correlated concurrently. It is hoped that early detection of AKI will lead to earlier intervention, thus enhancing our ability to develop beneficial therapies.
Read the detailed description
Acute kidney injury (AKI) is a common heterogeneous disease that complicates several medical and surgical conditions. Recent studies have demonstrated that the occurrence of AKI significantly increase the risk of adverse outcomes. Despite the advanced in modern medicine, the interventions for AKI are not improved. One major reason of the failure to shift therapeutic progress is the clinicians' widespread dependence upon serum creatinine, an unreliable marker during acute changes of renal function, for the diagnosis of AKI.
In the past decade, over 20 unique biomarkers of AKI had been explored. Among them, neutrophil gelatinase-associated lipocalin (NGAL), interleukin-18 (IL-18), and kidney injury molecule-1 (KIM-1) have received the most interest. None of them, however, is an idea one.
Cysteine-rich protein 61 (Cyr61), a secreted matrix-associated heparin-binding protein, belongs to the "CCN" family. It regulates a broad spectrum of cellular activities, including cell adhesion, migration, proliferation, survival, differentiation, apoptosis, angiogenesis, and extracellular matrix production of multiple cell types. By the kidney ischemic/reperfusion injury animal model, Cyr61 gene was found to be rapidly up-regulated in the renal outer medulla. That portion of the kidney is corresponding to the area of marginally oxygenated under normal condition and most tubular injury following renal ischemic/reperfusion injury.18 Elevation of Cyr61 protein was detected in the kidney and also in urine following injury, making it a potential marker of AKI.
Additionally, pulse diagnosis is an integrative part of traditional Chinese medicine. With spectral analysis of the pulse waves, researchers started to observe the pulse wave harmonics. An in vivo study of rats revealed that ligating one or both of the renal arteries significantly reduced the second harmonic component of the pressure pulse at the caudate artery. Ligating the artery toward the spleen prominently reduced the third harmonics component of the pulse. Analysis of the harmonics in the spectrum of the arterial pressure wave revealed that individual organs might have their own natural frequencies. These observations suggested that individual vascular beds exert independent, frequency-specific, effects on the peripheral pressure wave.
Among different etiologies, cardiac surgery is an important cause of AKI. It has been shown that AKI after cardiac surgery is relatively highly prevalent and prognostically important. Cardiac surgery is usually performed with the use of extracorporeal cardiopulmonary bypass machine ('on-pump').
Based on the evidence from cell culture study and animal study in the literature, we hypothesize that Cyr61 is rapidly increased in the urine after AKI. We thus design this project to evaluate study the diagnostic role and clinical application of Cyr61 in AKI. We will conduct a prospective cohort study to evaluate the changes of urinary Cyr61 in patients undergoing cardiac surgery. Cyr61 may serve a good biomarker for the early diagnosis of patients with AKI, either singly or in combination with NGAL. By the way, we also try to correlate the changes in those biomarker with a potential new tool：harmonic analysis of arterial pressure pulse waves. We have special interest in following the time course of changes in biomarker and correlate with changes in pulse analysis. Physiological parameters of vascular compliance and regional blood oxygen saturation will be correlated concurrently. It is hoped that early detection of AKI will lead to earlier intervention, thus enhancing our ability to develop beneficial therapies.
- Keywords
- Cardiac surgery, Acute kidney injury, Cyr-61, Pulse wave analysis
- 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 |
|---|---|---|
| Elective cardiac surgery | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute kidney injury
development of AKI within 1 week after cardiac surgery
Measured: 1 week after cardiac surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2013 (estimated)
- Study startApr 2013
- Primary completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Consecutive Incident Adult Patients Undergoing Elective Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- 150 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chun-Fu Lai, MD, Study director, Division of Nephrology, Department of Internal medicine, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01876134
- Sponsor's protocol ID
- 201210055RIC
- Status last verified
- Jun 2013
- First submitted
- 10 Jun 2013
- Last updated
- 12 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic Role of Cystein-rich Protein 61 (Cyr61) in Acute Kidney Injury: Correlation With the Harmonic Analysis of Arterial Pressure Pulse Waves.
- ClinicalTrials.gov ID
- NCT01876134
- Acronym / sponsor ID
- 201210055RIC
- Keywords
- Cardiac surgery, Acute kidney injury, Cyr-61, Pulse wave analysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jun 2014 (estimated)
- First posted
- 12 Jun 2013 (estimated)
- 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 heterogeneous disease that complicates several medical and surgical conditions. Recent studies have demonstrated that the occurrence of AKI significantly increase the risk of adverse outcomes. Despite the advanced in modern medicine, the interventions for AKI are not improved. One major reason of the failure to shift therapeutic progress is the clinicians' widespread dependence upon serum creatinine, an unreliable marker during acute changes of renal function, for the diagnosis of AKI.
In the past decade, over 20 unique biomarkers of AKI had been explored. Among them, neutrophil gelatinase-associated lipocalin (NGAL), interleukin-18 (IL-18), and kidney injury molecule-1 (KIM-1) have received the most interest. None of them, however, is an idea one.
Cysteine-rich protein 61 (Cyr61), a secreted matrix-associated heparin-binding protein, belongs to the "CCN" family. It regulates a broad spectrum of cellular activities, including cell adhesion, migration, proliferation, survival, differentiation, apoptosis, angiogenesis, and extracellular matrix production of multiple cell types. By the kidney ischemic/reperfusion injury animal model, Cyr61 gene was found to be rapidly up-regulated in the renal outer medulla. That portion of the kidney is corresponding to the area of marginally oxygenated under normal condition and most tubular injury following renal ischemic/reperfusion injury.18 Elevation of Cyr61 protein was detected in the kidney and also in urine following injury, making it a potential marker of AKI.
Additionally, pulse diagnosis is an integrative part of traditional Chinese medicine. With spectral analysis of the pulse waves, researchers started to observe the pulse wave harmonics. An in vivo study of rats revealed that ligating one or both of the renal arteries significantly reduced the second harmonic component of the pressure pulse at the caudate artery. Ligating the artery toward the spleen prominently reduced the third harmonics component of the pulse. Analysis of the harmonics in the spectrum of the arterial pressure wave revealed that individual organs might have their own natural frequencies. These observations suggested that individual vascular beds exert independent, frequency-specific, effects on the peripheral pressure wave.
Among different etiologies, cardiac surgery is an important cause of AKI. It has been shown that AKI after cardiac surgery is relatively highly prevalent and prognostically important. Cardiac surgery is usually performed with the use of extracorporeal cardiopulmonary bypass machine ('on-pump').
Based on the evidence from cell culture study and animal study in the literature, we hypothesize that Cyr61 is rapidly increased in the urine after AKI. We thus design this project to evaluate study the diagnostic role and clinical application of Cyr61 in AKI. We will conduct a prospective cohort study to evaluate the changes of urinary Cyr61 in patients undergoing cardiac surgery. Cyr61 may serve a good biomarker for the early diagnosis of patients with AKI, either singly or in combination with NGAL. By the way, we also try to correlate the changes in those biomarker with a potential new tool：harmonic analysis of arterial pressure pulse waves. We have special interest in following the time course of changes in biomarker and correlate with changes in pulse analysis. Physiological parameters of vascular compliance and regional blood oxygen saturation will be correlated concurrently. It is hoped that early detection of AKI will lead to earlier intervention, thus enhancing our ability to develop beneficial therapies.
Detailed description
Acute kidney injury (AKI) is a common heterogeneous disease that complicates several medical and surgical conditions. Recent studies have demonstrated that the occurrence of AKI significantly increase the risk of adverse outcomes. Despite the advanced in modern medicine, the interventions for AKI are not improved. One major reason of the failure to shift therapeutic progress is the clinicians' widespread dependence upon serum creatinine, an unreliable marker during acute changes of renal function, for the diagnosis of AKI.
In the past decade, over 20 unique biomarkers of AKI had been explored. Among them, neutrophil gelatinase-associated lipocalin (NGAL), interleukin-18 (IL-18), and kidney injury molecule-1 (KIM-1) have received the most interest. None of them, however, is an idea one.
Cysteine-rich protein 61 (Cyr61), a secreted matrix-associated heparin-binding protein, belongs to the "CCN" family. It regulates a broad spectrum of cellular activities, including cell adhesion, migration, proliferation, survival, differentiation, apoptosis, angiogenesis, and extracellular matrix production of multiple cell types. By the kidney ischemic/reperfusion injury animal model, Cyr61 gene was found to be rapidly up-regulated in the renal outer medulla. That portion of the kidney is corresponding to the area of marginally oxygenated under normal condition and most tubular injury following renal ischemic/reperfusion injury.18 Elevation of Cyr61 protein was detected in the kidney and also in urine following injury, making it a potential marker of AKI.
Additionally, pulse diagnosis is an integrative part of traditional Chinese medicine. With spectral analysis of the pulse waves, researchers started to observe the pulse wave harmonics. An in vivo study of rats revealed that ligating one or both of the renal arteries significantly reduced the second harmonic component of the pressure pulse at the caudate artery. Ligating the artery toward the spleen prominently reduced the third harmonics component of the pulse. Analysis of the harmonics in the spectrum of the arterial pressure wave revealed that individual organs might have their own natural frequencies. These observations suggested that individual vascular beds exert independent, frequency-specific, effects on the peripheral pressure wave.
Among different etiologies, cardiac surgery is an important cause of AKI. It has been shown that AKI after cardiac surgery is relatively highly prevalent and prognostically important. Cardiac surgery is usually performed with the use of extracorporeal cardiopulmonary bypass machine ('on-pump').
Based on the evidence from cell culture study and animal study in the literature, we hypothesize that Cyr61 is rapidly increased in the urine after AKI. We thus design this project to evaluate study the diagnostic role and clinical application of Cyr61 in AKI. We will conduct a prospective cohort study to evaluate the changes of urinary Cyr61 in patients undergoing cardiac surgery. Cyr61 may serve a good biomarker for the early diagnosis of patients with AKI, either singly or in combination with NGAL. By the way, we also try to correlate the changes in those biomarker with a potential new tool：harmonic analysis of arterial pressure pulse waves. We have special interest in following the time course of changes in biomarker and correlate with changes in pulse analysis. Physiological parameters of vascular compliance and regional blood oxygen saturation will be correlated concurrently. It is hoped that early detection of AKI will lead to earlier intervention, thus enhancing our ability to develop beneficial therapies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elective cardiac surgery | – | – |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive incident adult patients undergoing elective cardiac surgery (including coronary artery bypass graft, valve surgery, and correction of congenital heart diseases)
Key inclusion criteria (1 listed)
- All consecutive incident adult patients undergoing elective cardiac surgery (including coronary artery bypass graft, valve surgery, and correction of congenital heart diseases)
Key exclusion criteria (1 listed)
- age younger than 20 years or older than 80 years; pregnant woman; emergent cardiac surgery; use of intra-aortic balloon pump or extracorporeal membrane oxygenation after surgery, pre-existing severe renal insufficiency (defined as estimated glomerular filtration rate 15 cc/min or less by the Modification of Diet in Renal Disease study equation36); patients with end-stage renal disease under maintenance hemodialysis, peritoneal dialysis, or receiving kidney transplantation; use of radiocontrast ≤24 h prior to the surgery; use of nephrotoxic drugs before or during the 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
Acute kidney injury
Time frame: 1 week after cardiac surgery
development of AKI within 1 week after cardiac surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2013.
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.
Chun-Fu Lai, MD study director
Division of Nephrology, Department of Internal medicine, National Taiwan University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Consecutive Incident Adult Patients Undergoing Elective Cardiac Surgery, run by National Taiwan University Hospital.
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 12 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
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 injury (time frame: 1 week after cardiac surgery). 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 Jun 2013.