Acute Kidney InjuryRIPC-CINNCT02674451
Remote Ischemic Preconditioning to Prevent Contrast Nephropathy
A study testing Remote ischemic preconditioning in people with Acute Kidney Injury, run by Johns Hopkins University at 1 site in United States.
Trial summary
Contrast-medium induced nephropathy (CIN) is a frequent and devastating complication of coronary angiography, occurring in 10-50% of cases. As would be expected, the incidence of CIN is much higher in patients with underlying renal dysfunction. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- 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
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2014to 11 May 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing coronary angiography for stable or unstable coronary artery disease
- eGFR less than or equal to 60 mL/min/1.73 m2
Who cannot join
- Subjects with known upper extremity vascular disease
- Subjects with systolic blood pressure differential of 10 mmHg or higher in the upper extremities
- End stage renal disease on peritoneal or hemodialysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Remote Ischemic Preconditioning to Prevent Contrast-induced Nephropathy in Patients With Stable and Unstable Coronary Disease Undergoing Coronary Angiography.
Contrast-medium induced nephropathy (CIN) is a frequent and devastating complication of coronary angiography, occurring in 10-50% of cases. As would be expected, the incidence of CIN is much higher in patients with underlying renal dysfunction. Multiple trials have found CIN to be an independent predictor of prolonged hospitalization and both 30 day and 1 year mortality in patients with coronary artery disease. Intravenous contrast dye is felt to cause renal ischemia as the mechanism of injury. Unfortunately, despite the significant morbidity and mortality with CIN, there are few therapeutic interventions to reduce the risk with the exception of hydration and high dose statin therapy. Recently, remote ischemic preconditioning (RIPC), a process of inducing transient arm ischemia by inflating a blood pressure cuff to 200 mmHg for 3 repetitive 5 minute cycles, leads to a systemic cytoprotective response and ultimately reduces ischemic renal injury, myocardial injury, and even cerebral injury following coronary bypass grafting. While there is significant data supporting the role of RIPC in reducing systemic ischemic injury in surgical patients, there is only one small trial studying RIPC in patient's undergoing coronary angiography. The investigators hypothesize that RIPC will reduce the incidence of contrast-induced nephropathy in patients with baseline renal dysfunction undergoing coronary angiography for stable or unstable coronary artery disease.
Read the detailed description
Contrast-medium induced nephropathy (CIN) is a frequent and devastating complication of coronary angiography, occurring in 10-50% of cases dependent on individual risk factors (JACC 2004; 44:1393). Multiple trials have found CIN to be an independent predictor of prolonged hospitalization and both 30 day and 1 year mortality in patients with coronary artery disease (Clin Res Cardiol 2009;98:765, JACC 2004:44:1780, Ann Int Med 2009;150:170, JACC 2008; 51: 1419). The largest retrospective study of over 16,000 hospitalized patients exposed to iodinated contrast found an in-hospital mortality rate of 34% in subjects developing CIN versus 7% in matched control subjects (JAMA 1996;275:1489). Despite the incidence of CIN and the deleterious outcomes, few therapies exist to prevent CIN other than hydration and withdraw of nephrotoxic medications prior to coronary angiography.
Remote ischemic preconditioning (RIPC) is a protective response resulting from transient episodes of ischemia, followed by reperfusion, to vascular beds remote from the organ which will undergo the prolonged ischemic insult. Studies in humans indicate that RIPC decreases cardiac enzyme release, clinical events, and improves mortality in patients undergoing elective coronary bypass surgery (Circulation 2009;119:820; Lancet 2007;370:575, Lancet 2013; 382: 597). In addition to the cardio-protective effects of RIPC, a small, single center randomized trial showed a reduction in the incidence of contrast-medium induced nephropathy of approximately 30% in patients receiving RIPC prior to elective coronary angiography compared to a control population (Circulation 2012; 126:296). RIPC was safely performed in all of these studies by inflating a blood pressure cuff to supra-systolic levels (200mmHg) for 3 five minute episodes separated by 5 minutes of reperfusion.
RIPC is a well-tolerated, easily administered mechanism that may reduce the incidence of contrast-mediated nephropathy. However, additional and larger trials are needed to validate the use of RIPC in both elective and urgent coronary angiography in patients at risk for contrast-medicated nephropathy.
- Conditions
- Acute Kidney Injury
- Being tested
- Remote ischemic preconditioning
- 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.
Remote ischemic preconditioningProcedure or surgery
Blood pressure cuff inflation to 200 mmHG for three 5-minute periods each separated by 5 minute intervals within 1 hour of planned coronary angiography.
| Study group | Role | What they receive |
|---|---|---|
| RIPC | Active comparator | Participants will receive remote ischemic preconditioning within one hour of coronary angiography. This involves blood pressure cuff inflation to 200mmHG for three-5 minute periods, each separated by 5 minute intervals. Receives: Procedure: Remote ischemic preconditioning |
| Controls | Sham comparator | Participants will have routine blood pressure measurements will be obtained. Receives: Procedure: Remote ischemic preconditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute kidney injury
Increase in serum creatinine greater than or equal to 0.05 mg/dL or a relative increase of greater than or equal to 25% of baseline.
Measured: 48 hours after contrast administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2016 (estimated)
- Study start12 Aug 2014
- Primary completion11 May 2017
- Study completion11 May 2017
Why it stopped: poor enrollment
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.
- More trials run by Johns Hopkins 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven P Schulman, M.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02674451
- Sponsor's protocol ID
- IRB00036762
- Acronym
- RIPC-CIN
- Status last verified
- Sep 2018
- First submitted
- 1 Feb 2016
- Last updated
- 6 Sep 2018
- 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 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Ischemic Preconditioning to Prevent Contrast-induced Nephropathy in Patients With Stable and Unstable Coronary Disease Undergoing Coronary Angiography.
- ClinicalTrials.gov ID
- NCT02674451
- Acronym / sponsor ID
- RIPC-CIN / IRB00036762
- Conditions
- Acute Kidney Injury
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor enrollment
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 12 Aug 2014 (actual)
- Primary completion
- 11 May 2017 (actual)
- Study completion
- 11 May 2017 (actual)
- First posted
- 4 Feb 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.
Contrast-medium induced nephropathy (CIN) is a frequent and devastating complication of coronary angiography, occurring in 10-50% of cases. As would be expected, the incidence of CIN is much higher in patients with underlying renal dysfunction. Multiple trials have found CIN to be an independent predictor of prolonged hospitalization and both 30 day and 1 year mortality in patients with coronary artery disease. Intravenous contrast dye is felt to cause renal ischemia as the mechanism of injury. Unfortunately, despite the significant morbidity and mortality with CIN, there are few therapeutic interventions to reduce the risk with the exception of hydration and high dose statin therapy. Recently, remote ischemic preconditioning (RIPC), a process of inducing transient arm ischemia by inflating a blood pressure cuff to 200 mmHg for 3 repetitive 5 minute cycles, leads to a systemic cytoprotective response and ultimately reduces ischemic renal injury, myocardial injury, and even cerebral injury following coronary bypass grafting. While there is significant data supporting the role of RIPC in reducing systemic ischemic injury in surgical patients, there is only one small trial studying RIPC in patient's undergoing coronary angiography. The investigators hypothesize that RIPC will reduce the incidence of contrast-induced nephropathy in patients with baseline renal dysfunction undergoing coronary angiography for stable or unstable coronary artery disease.
Detailed description
Contrast-medium induced nephropathy (CIN) is a frequent and devastating complication of coronary angiography, occurring in 10-50% of cases dependent on individual risk factors (JACC 2004; 44:1393). Multiple trials have found CIN to be an independent predictor of prolonged hospitalization and both 30 day and 1 year mortality in patients with coronary artery disease (Clin Res Cardiol 2009;98:765, JACC 2004:44:1780, Ann Int Med 2009;150:170, JACC 2008; 51: 1419). The largest retrospective study of over 16,000 hospitalized patients exposed to iodinated contrast found an in-hospital mortality rate of 34% in subjects developing CIN versus 7% in matched control subjects (JAMA 1996;275:1489). Despite the incidence of CIN and the deleterious outcomes, few therapies exist to prevent CIN other than hydration and withdraw of nephrotoxic medications prior to coronary angiography.
Remote ischemic preconditioning (RIPC) is a protective response resulting from transient episodes of ischemia, followed by reperfusion, to vascular beds remote from the organ which will undergo the prolonged ischemic insult. Studies in humans indicate that RIPC decreases cardiac enzyme release, clinical events, and improves mortality in patients undergoing elective coronary bypass surgery (Circulation 2009;119:820; Lancet 2007;370:575, Lancet 2013; 382: 597). In addition to the cardio-protective effects of RIPC, a small, single center randomized trial showed a reduction in the incidence of contrast-medium induced nephropathy of approximately 30% in patients receiving RIPC prior to elective coronary angiography compared to a control population (Circulation 2012; 126:296). RIPC was safely performed in all of these studies by inflating a blood pressure cuff to supra-systolic levels (200mmHg) for 3 five minute episodes separated by 5 minutes of reperfusion.
RIPC is a well-tolerated, easily administered mechanism that may reduce the incidence of contrast-mediated nephropathy. However, additional and larger trials are needed to validate the use of RIPC in both elective and urgent coronary angiography in patients at risk for contrast-medicated nephropathy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIPC | Active comparator | Procedure: Remote ischemic preconditioningParticipants will receive remote ischemic preconditioning within one hour of coronary angiography. This involves blood pressure cuff inflation to 200mmHG for three-5 minute periods, each separated by 5 minute intervals. |
| Controls | Sham comparator | Procedure: Remote ischemic preconditioningParticipants will have routine blood pressure measurements will be obtained. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing coronary angiography for stable or unstable coronary artery disease
- eGFR less than or equal to 60 mL/min/1.73 m2
Key exclusion criteria (3 listed)
- Subjects with known upper extremity vascular disease
- Subjects with systolic blood pressure differential of 10 mmHg or higher in the upper extremities
- End stage renal disease on peritoneal or hemodialysis
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 preconditioningBlood pressure cuff inflation to 200 mmHG for three 5-minute periods each separated by 5 minute intervals within 1 hour of planned coronary angiography. | Procedure or surgery | Controls, RIPC |
Primary outcome
Acute kidney injury
Time frame: 48 hours after contrast administration
Increase in serum creatinine greater than or equal to 0.05 mg/dL or a relative increase of greater than or equal to 25% of baseline.
Results and safety
The study was stopped early (reason given: poor enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
- Individual participant dataSharing planned: No
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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.
Steven P Schulman, M.D. principal investigator
Johns Hopkins University
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 Acute Kidney Injury, run by Johns Hopkins University at 1 site in United States.
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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 6 Sep 2018. 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 United States. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: poor enrollment). 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: 48 hours after contrast administration). 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 6 Sep 2018.