Contrast Induced NephropathyACTINNCT02650336
Aging Biomakers and ConTrast Induced Nephropathy (ACTIN) Trial
An observational study of Contrast Induced Nephropathy, run by Sun Yat-sen University at 1 site in China.
Trial summary
Biomarkers such as kidney injury molecule-1 (KIM-1) and neutrophil gelatinase-associated lipocalin (NGAL) have been used for the early diagnosis of AKI, although with no definitive results. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contrast Induced Nephropathy
- What is being tested?
- contrast
- How many people
- 592 participants
- Where
- 1 siteChina
- Study dates
- Oct 2013to Sep 2015
- 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 aged 18 years or older undergoing planed PCI at the institution of first affiliated hospital of SYSU were prospectively recruited between May 2014 and July 2015. The exclusion criteria were pregnancy, lactation, sepsis, the intravascular administration of a contrast medium within the past 7 days, nephroprotective drug treatment (e.g., N-acetylcysteine, theophylline, sodium bicarbonate, prostaglandin E1), nephrotoxic drug intake (e.g., non-steroidal anti-inflammatory drugs, metformin, aminoglycosides, cisplatin) within the past 7 days, a history of serious allergic to contrast media, renal transplantation, end-stage renal disease necessitating dialysis, and severe concomitant disease of other systems.
Who may be able to join
- Patients aged 18 years or older undergoing planed PCI were prospectively recruited
Who cannot join
- Pregnancy
- Lactation
- Sepsis
- The intravascular administration of a contrast medium within the past 7 days, nephroprotective drug treatment (e.g., N-acetylcysteine, theophylline, sodium bicarbonate, prostaglandin E1)
- Nephrotoxic drug intake (e.g., non-steroidal anti-inflammatory drugs, metformin, aminoglycosides, cisplatin) within the past 7 days
- A history of serious allergic to contrast media
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- Renal transplantation
- End-stage renal disease necessitating dialysis
- Severe concomitant disease of other systems.
Trial locations and contacts
1 site in 1 country.
About this study
Biomarkers such as kidney injury molecule-1 (KIM-1) and neutrophil gelatinase-associated lipocalin (NGAL) have been used for the early diagnosis of AKI, although with no definitive results. The investigators explored the association between plasma aging biomakers such as sklotho and contrast induced nephropathy in patients undergoing percutaneous coronary intervention (PCI) with contrast injection.
Read the detailed description
Acute kidney injury represents an important clinical problem in hospitalized patients, with persistently high rates of mortality and morbidity. With an ever-increasing number of patients receiving intravascular injection of iodinated contrast media worldwide, contrast induced nephropathy (CIN) has become the third leading cause of hospital-acquired AKI. Approximately half of these cases are in patients undergoing cardiac catheterization procedures.
The prevention and early intervention of CIN has been hampered mainly by the lack of a consensus definition and the paucity of early predictive biomarkers to accurately identify high-risk patients. CIN is most frequently defined as an increase in serum creatinine (sCr) by 25-50% above the baseline, generally occurring within the first 24 h after contrast exposure, in the absence of other causes. However, sCr is an unreliable indicator during acute changes in kidney function, and alterations in sCr levels are not particularly sensitive or specific for small changes in the glomerular filtration rate (GFR)e, gender, race and intravascular volume. Biomarkers such as kidney injury molecule-1 (KIM-1) and neutrophil gelatinase-associated lipocalin (NGAL) have been used for the early diagnosis of AKI, although with no definitive results.
- Conditions
- Contrast Induced Nephropathy
- Being tested
- contrast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
contrastDrug
Also called low-osmolar, non-ionic contrast medium
a substance used to enhance the contrast of structures or fluids within the body in medical imaging. It is commonly used to enhance the visibility of blood vessels and the gastrointestinal tract
| Study group | Role | What they receive |
|---|---|---|
| CIN proup | The occurrence of CIN was defined as an increase in serum creatinine of 0.5 mg/dL above the baseline value within 48-72 h after PCI. Follow-up SCr and BUN levels were measured 1, 2, and 3 days after the procedure. Receives: Drug: contrast | |
| control group | The occurrence of CIN was defined as an increase in serum creatinine of 0.5 mg/dL above the baseline value within 48-72 h after PCI. Follow-up SCr and BUN levels were measured 1, 2, and 3 days after the procedure. Receives: Drug: contrast |
What is being measured
The primary outcome is the main question the study is designed to answer.
The association between plasma aging biomakers and contrast induced nephropathy
The plasma concentrations human soluble a-Klotho levels were measured by Enzyme Linked Immunosorbent Assay (ELISA) (Immuno-Biologic Laboratories Co., Ltd. Japan). This novel method detects sklotho using a monoclonal antibody with high affinity to the human a-Klotho protein.Hs-CRP was tested with a Beckman Coulter Immage immunobiochemistry system (USA) using nephelometry (unit: mg/L). Creatinine clearance (CrCl) was calculated by applying the Cockcroft- Gault formula to the serum creatinine concentration.
Measured: 48-72 hours
Secondary outcomes (1)
The association between plasma aging biomakers and in-hospital MACE in patients undergoing percutaneous coronary intervention (PCI) with contrast injection.
In-hospital major adverse cardiovascular events (MACE):defined as (1) death, (2) nonfatal myocardial infarction, or (3) target vessel revascularization. Myocardial infarction was diagnosed by a rise in the creatine kinase level to more than twice the upper normal limit with an increased creatine kinase-MB. Target lesion revascularization was defined as a repeat intervention (surgical or percutaneous) to treat a luminal stenosis within the stent or in the 5-mm distal or proximal segments adjacent to the stent. Target vessel revascularization was defined as a reintervention driven by any lesion located in the same epicardial vessel. Thrombotic stent occlusion was angiographically documented as a complete occlusion (TIMI flow 0 or 1) or a flow-limiting thrombus (TIMI flow 1 or 2) of a previously successfully treated artery.
Measured: 30 days, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2016 (estimated)
- Study startOct 2013
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contrast Induced NephropathyStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 592 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao-dong Zhuang, Sun Yat-sen University
- Investigators
- zhimin du, MD, Principal investigator, fitst affiliated hospital of SYSU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02650336
- Sponsor's protocol ID
- ACTIN-sysu
- Acronym
- ACTIN
- Status last verified
- Jan 2016
- First submitted
- 3 Jan 2016
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aging Biomakers and ConTrast Induced Nephropathy (ACTIN) Trial
- ClinicalTrials.gov ID
- NCT02650336
- Acronym / sponsor ID
- ACTIN / ACTIN-sysu
- Conditions
- Contrast Induced Nephropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 592 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 8 Jan 2016 (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.
Biomarkers such as kidney injury molecule-1 (KIM-1) and neutrophil gelatinase-associated lipocalin (NGAL) have been used for the early diagnosis of AKI, although with no definitive results. The investigators explored the association between plasma aging biomakers such as sklotho and contrast induced nephropathy in patients undergoing percutaneous coronary intervention (PCI) with contrast injection.
Detailed description
Acute kidney injury represents an important clinical problem in hospitalized patients, with persistently high rates of mortality and morbidity. With an ever-increasing number of patients receiving intravascular injection of iodinated contrast media worldwide, contrast induced nephropathy (CIN) has become the third leading cause of hospital-acquired AKI. Approximately half of these cases are in patients undergoing cardiac catheterization procedures.
The prevention and early intervention of CIN has been hampered mainly by the lack of a consensus definition and the paucity of early predictive biomarkers to accurately identify high-risk patients. CIN is most frequently defined as an increase in serum creatinine (sCr) by 25-50% above the baseline, generally occurring within the first 24 h after contrast exposure, in the absence of other causes. However, sCr is an unreliable indicator during acute changes in kidney function, and alterations in sCr levels are not particularly sensitive or specific for small changes in the glomerular filtration rate (GFR)e, gender, race and intravascular volume. Biomarkers such as kidney injury molecule-1 (KIM-1) and neutrophil gelatinase-associated lipocalin (NGAL) have been used for the early diagnosis of AKI, although with no definitive results.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CIN proup | – | Drug: contrastThe occurrence of CIN was defined as an increase in serum creatinine of 0.5 mg/dL above the baseline value within 48-72 h after PCI. Follow-up SCr and BUN levels were measured 1, 2, and 3 days after the procedure. |
| control group | – | Drug: contrastThe occurrence of CIN was defined as an increase in serum creatinine of 0.5 mg/dL above the baseline value within 48-72 h after PCI. Follow-up SCr and BUN levels were measured 1, 2, and 3 days after the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 years or older undergoing planed PCI at the institution of first affiliated hospital of SYSU were prospectively recruited between May 2014 and July 2015. The exclusion criteria were pregnancy, lactation, sepsis, the intravascular administration of a contrast medium within the past 7 days, nephroprotective drug treatment (e.g., N-acetylcysteine, theophylline, sodium bicarbonate, prostaglandin E1), nephrotoxic drug intake (e.g., non-steroidal anti-inflammatory drugs, metformin, aminoglycosides, cisplatin) within the past 7 days, a history of serious allergic to contrast media, renal transplantation, end-stage renal disease necessitating dialysis, and severe concomitant disease of other systems.
Key inclusion criteria (1 listed)
- Patients aged 18 years or older undergoing planed PCI were prospectively recruited
Key exclusion criteria (9 listed)
- Pregnancy
- Lactation
- Sepsis
- The intravascular administration of a contrast medium within the past 7 days, nephroprotective drug treatment (e.g., N-acetylcysteine, theophylline, sodium bicarbonate, prostaglandin E1)
- Nephrotoxic drug intake (e.g., non-steroidal anti-inflammatory drugs, metformin, aminoglycosides, cisplatin) within the past 7 days
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 |
|---|---|---|
| contrastAlso: low-osmolar, non-ionic contrast mediuma substance used to enhance the contrast of structures or fluids within the body in medical imaging. It is commonly used to enhance the visibility of blood vessels and the gastrointestinal tract | Drug | CIN proup, control group |
Primary outcome
The association between plasma aging biomakers and contrast induced nephropathy
Time frame: 48-72 hours
The plasma concentrations human soluble a-Klotho levels were measured by Enzyme Linked Immunosorbent Assay (ELISA) (Immuno-Biologic Laboratories Co., Ltd. Japan). This novel method detects sklotho using a monoclonal antibody with high affinity to the human a-Klotho protein.Hs-CRP was tested with a Beckman Coulter Immage immunobiochemistry system (USA) using nephelometry (unit: mg/L). Creatinine clearance (CrCl) was calculated by applying the Cockcroft- Gault formula to the serum creatinine concentration.
1 secondary outcome
The association between plasma aging biomakers and in-hospital MACE in patients undergoing percutaneous coronary intervention (PCI) with contrast injection.
Time frame: 30 days, 1 year
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 8 Jan 2016.
- Individual participant dataSharing planned: No
Related trials for Contrast Induced Nephropathy
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Contrast-induced Acute Kidney Injury (CI-AKI) Following Coronary Angiogram (CI-AKI), Contrast-induced Nephropathy Following Coronary Angiogram (CIN)
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Uric Acid to Albumin Ratio for Predicting Contrast Associated Acute Kidney Injury After Cardiac and Non Cardiac Procedures
Contrast-Induced Nephropathy, Acute Kidney Injury
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Beyond the Mehran Risk Score: Predictive Value of Total Ischemic Time for Contrast-Induced Nephropathy in ST Segment Elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention.
ST Elevation (STEMI) Myocardial Infarction, Contrast Induced Nephropathy (CIN)
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Contrast Volume as a Predictor of Kidney Injury Following Contrast-Enhanced CT
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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.
zhimin du, MD principal investigator
fitst affiliated hospital of SYSU
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 Contrast Induced Nephropathy, run by Sun Yat-sen University 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 1 inclusion and 9 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 8 Jan 2016. 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 association between plasma aging biomakers and contrast induced nephropathy (time frame: 48-72 hours). 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 8 Jan 2016.