Contrast Induced Acute Kidney InjuryNCT02329444
The Effect of Remote Ischemic Preconditioning on Elective Percutaneous Coronary Intervention in Diabetic Nephropathy
A study testing Remote ischemic preconditioning in people with Contrast Induced Acute Kidney Injury, run by Ulsan University Hospital at 1 site in South Korea.
Trial summary
Contrast-induced acute kidney injury (CI-AKI) is a significant iatrogenic complication of contrast media use associated with prolonged hospitalization, cardiovascular events, persistent kidney damage and increased risk of all-cause mortality. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Contrast Induced Acute Kidney Injury
- What is being tested?
- Remote ischemic preconditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2014to Mar 2015
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed written consent
- All of the following:
- Known diagnosis of Type 2 diabetes
- NSTEMI, unstable or stable angina
- Patients undergoing elective coronary angiography and/or percutaneous coronary intervention
- eGFR < 60 mls/min or ACR > 300 mg/dl
Who cannot join
- STEMI
- decompensated heart failure in the preceding 6 months
- patients with underlying end stage renal disease on maintenance dialysis
- recent (in the last 3 months) cerebrovascular disease
- chronic liver disease
- chronic obstructive pulmonary disease
- gastrointestinal bleeding
- acute or chronic infection or malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Remote Ischemic Preconditioning for the Prevention of Contrast-induced Acute Kidney Injury in Diabetic Patients Undergoing Percutaneous Coronary Intervention
Contrast-induced acute kidney injury (CI-AKI) is a significant iatrogenic complication of contrast media use associated with prolonged hospitalization, cardiovascular events, persistent kidney damage and increased risk of all-cause mortality. When remote ischemic preconditioning is applied before percutaneous coronary intervention (PCI), the kidneys can be protected against ischemia-reperfusion injury and subsequently CI-AKI. In this randomised controlled trial, diabetic nephropathy patients undergoing PCI as part of their assessment and treatment of cardiovascular disease are randomized to receive RIPC or control sham preconditioning.
Read the detailed description
Contrast-induced acute kidney injury (CI-AKI) is a significant iatrogenic complication of contrast media use associated with prolonged hospitalization, cardiovascular events, persistent kidney damage and increased risk of all-cause mortality. Diabetes with pre-existing renal disease can increase the risk of CI-AKI. Remote ischemic preconditioning (RIPC) is a non-pharmacological strategy inducing transient episodes of ischemia by the occlusion of blood flow in non-target tissue such as a limb, before a subsequent prolonged ischemia-reperfusion injury occurs in a more distant organ. These brief, repeated ischemic episodes in the limb can confer a protection at more remote sites such as the heart, brain, lung, kidney, intestine or skeletal muscle. In a recent pilot study, using RIPC prior to coronary angiography in high risk patients with moderate chronic kidney disease, the authors found that RIPC significantly reduced the incidence of CI-AKI (Er et al Circulation. 2012;126(3),296). We hypothesized that RIPC would be protective as an adjunctive therapy in reducing the incidence of CI-AKI in diabetics with pre-existing CKD. This prospective study was performed to evaluate the efficacy of RIPC for the prevention of CI-AKI among diabetic nephropathy patients undergoing percutaneous coronary intervention.
- Conditions
- Contrast Induced Acute Kidney Injury
- Being tested
- Remote ischemic preconditioning, Sham ischemic preconditioning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic preconditioningProcedure or surgery
Appropriately sized sphygmomanometer cuff placed around right upper arm; where contraindicated, left arm, with inflation of the cuff up to 200mmHg for 5 minutes, followed by deflation of 5 minutes to allow reperfusion with cycle repeated 3 times.
Sham ischemic preconditioningProcedure or surgery
Appropriately sized sphygmomanometer cuff placed around right upper arm; where contraindicated, left arm, with inflation of the cuff up to 50mmHg for 5 minutes, followed by deflation of 5 minutes to allow reperfusion with cycle repeated 3 times.
| Study group | Role | What they receive |
|---|---|---|
| Remote Ischemic Preconditioning | Experimental | Patients treated with Remote Ischemic Preconditioning Receives: Procedure: Remote ischemic preconditioning |
| Sham ischemic preconditioning | Active comparator | Patients treated with sham ischemic preconditioning Receives: Procedure: Sham ischemic preconditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of CI-AKI
defined as a creatinine rise of ≥ 25% or an increase of > 0.5mg/dl from baseline within 48 hours after contrast exposure
Measured: 48 hours
Secondary outcomes (3)
Relative change in NGAL levels from baseline
Defined as a change in serum NGAL value from baseline
Measured: 24 hours
Absolute change in NGAL levels from baseline
Defined as a change in serum NGAL value from baseline
Measured: 24 hours
Relative change in serum creatinine from baseline
Defined as a change in serum value from baseline
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startAug 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Contrast Induced 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulsan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Eun-Seok Shin, MD. PhD., Ulsan University Hospital
- Investigators
- Eun-Seok Shin, MD., PhD., Principal investigator, Ulsan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02329444
- Sponsor's protocol ID
- 2011-08-074
- Status last verified
- Apr 2019
- First submitted
- 29 Dec 2014
- Last updated
- 3 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Balbir Singh G, Ann SH, Park J, Chung HC, Lee JS, Kim ES, Choi JI, Lee J, Kim SJ, Shin ES. Remote Ischemic Preconditioning for the Prevention of Contrast-Induced Acute Kidney Injury in Diabetics Receiving Elective Percutaneous Coronary Intervention. PLoS One. 2016 Oct 10;11(10):e0164256. doi: 10.1371/journal.pone.0164256. eCollection 2016.
PubMed 27723839
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Ischemic Preconditioning for the Prevention of Contrast-induced Acute Kidney Injury in Diabetic Patients Undergoing Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT02329444
- Acronym / sponsor ID
- 2011-08-074
- Conditions
- Contrast Induced Acute Kidney Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ulsan University HospitalUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 31 Dec 2014 (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.
Contrast-induced acute kidney injury (CI-AKI) is a significant iatrogenic complication of contrast media use associated with prolonged hospitalization, cardiovascular events, persistent kidney damage and increased risk of all-cause mortality. When remote ischemic preconditioning is applied before percutaneous coronary intervention (PCI), the kidneys can be protected against ischemia-reperfusion injury and subsequently CI-AKI. In this randomised controlled trial, diabetic nephropathy patients undergoing PCI as part of their assessment and treatment of cardiovascular disease are randomized to receive RIPC or control sham preconditioning.
Detailed description
Contrast-induced acute kidney injury (CI-AKI) is a significant iatrogenic complication of contrast media use associated with prolonged hospitalization, cardiovascular events, persistent kidney damage and increased risk of all-cause mortality. Diabetes with pre-existing renal disease can increase the risk of CI-AKI. Remote ischemic preconditioning (RIPC) is a non-pharmacological strategy inducing transient episodes of ischemia by the occlusion of blood flow in non-target tissue such as a limb, before a subsequent prolonged ischemia-reperfusion injury occurs in a more distant organ. These brief, repeated ischemic episodes in the limb can confer a protection at more remote sites such as the heart, brain, lung, kidney, intestine or skeletal muscle. In a recent pilot study, using RIPC prior to coronary angiography in high risk patients with moderate chronic kidney disease, the authors found that RIPC significantly reduced the incidence of CI-AKI (Er et al Circulation. 2012;126(3),296). We hypothesized that RIPC would be protective as an adjunctive therapy in reducing the incidence of CI-AKI in diabetics with pre-existing CKD. This prospective study was performed to evaluate the efficacy of RIPC for the prevention of CI-AKI among diabetic nephropathy patients undergoing percutaneous coronary intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote Ischemic Preconditioning | Experimental | Procedure: Remote ischemic preconditioningPatients treated with Remote Ischemic Preconditioning |
| Sham ischemic preconditioning | Active comparator | Procedure: Sham ischemic preconditioningPatients treated with sham ischemic preconditioning |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Informed written consent
- All of the following:
- Known diagnosis of Type 2 diabetes
- NSTEMI, unstable or stable angina
- Patients undergoing elective coronary angiography and/or percutaneous coronary intervention
Key exclusion criteria (8 listed)
- STEMI
- decompensated heart failure in the preceding 6 months
- patients with underlying end stage renal disease on maintenance dialysis
- recent (in the last 3 months) cerebrovascular disease
- chronic liver disease
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 |
|---|---|---|
| Remote ischemic preconditioningAppropriately sized sphygmomanometer cuff placed around right upper arm; where contraindicated, left arm, with inflation of the cuff up to 200mmHg for 5 minutes, followed by deflation of 5 minutes to allow reperfusion with cycle repeated 3 times. | Procedure or surgery | Remote Ischemic Preconditioning |
| Sham ischemic preconditioningAppropriately sized sphygmomanometer cuff placed around right upper arm; where contraindicated, left arm, with inflation of the cuff up to 50mmHg for 5 minutes, followed by deflation of 5 minutes to allow reperfusion with cycle repeated 3 times. | Procedure or surgery | Sham ischemic preconditioning |
Primary outcome
Incidence of CI-AKI
Time frame: 48 hours
defined as a creatinine rise of ≥ 25% or an increase of > 0.5mg/dl from baseline within 48 hours after contrast exposure
3 secondary outcomes
Relative change in NGAL levels from baseline
Time frame: 24 hours
Absolute change in NGAL levels from baseline
Time frame: 24 hours
Relative change in serum creatinine from baseline
Time frame: 72 hours
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 3 Apr 2019.
- Derived from this study: PubMed 27723839Balbir Singh G, Ann SH, Park J, Chung HC, Lee JS, Kim ES, Choi JI, Lee J, Kim SJ, Shin ES. Remote Ischemic Preconditioning for the Prevention of Contrast-Induced Acute Kidney Injury in Diabetics Receiving Elective Percutaneous Coronary Intervention. PLoS One. 2016 Oct 10;11(10):e0164256. doi: 10.1371/journal.pone.0164256. eCollection 2016.
Related trials for Contrast Induced Acute Kidney Injury
Recruiting
Effectiveness of Remote Ischemic Preconditioning for Prevention of Contrast Induced Acute Kidney Injury in Patients Undergoing Coronary Angiograms.
Contrast-induced Acute Kidney Injury (CI-AKI) Following Coronary Angiogram (CI-AKI), Contrast-induced Nephropathy Following Coronary Angiogram (CIN)
Not yet recruitingObservational study
Uric Acid to Albumin Ratio for Predicting Contrast Associated Acute Kidney Injury After Cardiac and Non Cardiac Procedures
Contrast-Induced Nephropathy, Acute Kidney Injury
Not yet recruitingObservational study
An Observational Study of Percutaneous Glomerular Filtration Rate (TGFR) in the Early Warning of Contrast-induced Acute Kidney Injury During the Peri-examination Period of Emergency Enhanced CT
Contrast-associated Acute Kidney Injury
Not yet recruitingObservational study
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)
Not yet recruitingObservational study
Contrast Volume as a Predictor of Kidney Injury Following Contrast-Enhanced CT
Contrast-Associated Acute Kidney Injury, Acute Kidney Injury
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.
Eun-Seok Shin, MD., PhD. principal investigator
Ulsan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote ischemic preconditioning in people with Contrast Induced Acute Kidney Injury, run by Ulsan University Hospital at 1 site in South Korea.
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 6 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 3 Apr 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 South Korea. 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?
Incidence of CI-AKI (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02329444, which also lists 1 linked publication.
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 3 Apr 2019.