Acute Kidney InjuryPhase 4EUROCRIPSNCT02195726
Efficacy of RIPC to Reduce AKI for Patients Undergoing PCI
A Phase 4 study testing Remote ischemic preconditioning in people with Acute Kidney Injury, run by A.O.U. Città della Salute e della Scienza at 7 sites in 3 countries.
Trial summary
The purpose of the present study is to determine if remote ischemic preconditioning reduces incidence of acute kidney injury in patients with reduced kidney function undergoing Percutaneous Coronary Intervention. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- 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
- 1,110 participants
- Where
- 7 sitesin 3 countries
- Study dates
- Jan 2013to Jul 2014
- Phase
- Phase 4
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- undergoing PCI with stenting for all clinical indications
- carrying (with) a renal clearance less than 60 mL/min/1.73 m2 and more than 30 mL/min/1.73 m2 (evaluated through MDRD); ù
- younger than 85 years old.
Who cannot join
- ST Segment Elevation Myocardial Infarction (STEMI), unstable hemodynamic presentations (cardiogenic shock) or ongoing severe arrhythmias;
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Italy5 sites
Unità Operativa di Cardiologia Presidio Ospedaliero Misericordia Via Senese 161 58100 Grosseto
Grosseto
Azienda Ospedaliere Senese Siena
Siena
Ospedale Maria Vittoria
Turin, 10016
San Luigi
Turin, 10016
Città Della Salute e Della Scienza
Turin
About this study
Official title: The EUROpean and Asian Cardiac and Renal Remote Ischemic Pre-conditioning Study : A Prospective, Randomized Control Trial
The purpose of the present study is to determine if remote ischemic preconditioning reduces incidence of acute kidney injury in patients with reduced kidney function undergoing Percutaneous Coronary Intervention.
Read the detailed description
Acute kidney injury negatively impacts on prognosis after PCI, and only hydratation have shown to reduce this complication.
Remote ischemic preconditioning has been demonstrated to reduce periprocedural MI, while impact on aki remains to be assessed
- Conditions
- Acute Kidney Injury
- Being tested
- Remote ischemic preconditioning, Sham 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
four times 5-minute inflations of a blood pressure cuff to 200 mmHg around the upper non dominant arm (or if systolic pressure is more than 150 mmHg, inflation will reach 50 mmHg up per than baseline), followed by 5-minute intervals of reperfusion.
Sham remote ischemic preconditioningProcedure or surgery
In the control group sham preconditioning will be performed with inflation of 10 mmHg more than baseline.
| Study group | Role | What they receive |
|---|---|---|
| Sham remote ischemic preconditioning' | Sham comparator | In the control group Sham remote ischemic preconditioning will be performed with inflation of 10 mmHg more than baseline Receives: Procedure: Sham remote ischemic preconditioning |
| Remote ischemic preconditioning | Experimental | In the experimental group, patients will receive for four times 5-minute inflations of a blood pressure cuff to 200 mmHg around the upper non dominant arm (or if systolic pressure is more than 150 mmHg, inflation will reach 50 mmHg upper than baseline), followed by 5-minute intervals of reperfusion.
In subjects presenting with BMI > 30 a dedicated blood pressure cuff for obese patients will be used. Coronary angiography will be performed in 45 minutes from last inflation Receives: Procedure: Remote ischemic preconditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute kidney injury
Acute Kidney Injury defined as Acute kidney injury is defined as an increase serum creatinine greater than 0.5 mg/dL, or by a relative increase of at least 25% over the baseline value within a period of 48-hours after contrast medium administration
Measured: 24 and 48 hours after PCI
Secondary outcomes (1)
Incidence of periprocedural myocardial infarction
Measured: 24 and 48 hours after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2014 (estimated)
- Study startJan 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,110 participants (actual)
Sponsor and investigators
- Lead sponsor
- A.O.U. Città della Salute e della Scienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudio Moretti, A.O.U. Città della Salute e della Scienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02195726
- Sponsor's protocol ID
- 201301
- Acronym
- EUROCRIPS
- Status last verified
- Jul 2014
- First submitted
- 14 Jan 2013
- Last updated
- 21 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
D'Ascenzo F, Femmino S, Ravera F, Angelini F, Caccioppo A, Franchin L, Grosso A, Comita S, Cavallari C, Penna C, De Ferrari GM, Camussi G, Pagliaro P, Brizzi MF. Extracellular vesicles from patients with Acute Coronary Syndrome impact on ischemia-reperfusion injury. Pharmacol Res. 2021 Aug;170:105715. doi: 10.1016/j.phrs.2021.105715. Epub 2021 Jun 7.
PubMed 34111564Moretti C, Cerrato E, Cavallero E, Lin S, Rossi ML, Picchi A, Sanguineti F, Ugo F, Palazzuoli A, Bertaina M, Presbitero P, Shao-Liang C, Pozzi R, Giammaria M, Limbruno U, Lefevre T, Gasparetto V, Garbo R, Omede P, Sheiban I, Escaned J, Biondi-Zoccai G, Gaita F, Perl L, D'Ascenzo F. The EUROpean and Chinese cardiac and renal Remote Ischemic Preconditioning Study (EURO-CRIPS CardioGroup I): A randomized controlled trial. Int J Cardiol. 2018 Apr 15;257:1-6. doi: 10.1016/j.ijcard.2017.12.033.
PubMed 29506674
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The EUROpean and Asian Cardiac and Renal Remote Ischemic Pre-conditioning Study : A Prospective, Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02195726
- Acronym / sponsor ID
- EUROCRIPS / 201301
- Conditions
- Acute Kidney Injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,110 participants (actual)
- Lead sponsor
- A.O.U. Città della Salute e della ScienzaUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 21 Jul 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.
The purpose of the present study is to determine if remote ischemic preconditioning reduces incidence of acute kidney injury in patients with reduced kidney function undergoing Percutaneous Coronary Intervention.
Detailed description
Acute kidney injury negatively impacts on prognosis after PCI, and only hydratation have shown to reduce this complication.
Remote ischemic preconditioning has been demonstrated to reduce periprocedural MI, while impact on aki remains to be assessed
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham remote ischemic preconditioning' | Sham comparator | Procedure: Sham remote ischemic preconditioningIn the control group Sham remote ischemic preconditioning will be performed with inflation of 10 mmHg more than baseline |
| Remote ischemic preconditioning | Experimental | Procedure: Remote ischemic preconditioningIn the experimental group, patients will receive for four times 5-minute inflations of a blood pressure cuff to 200 mmHg around the upper non dominant arm (or if systolic pressure is more than 150 mmHg, inflation will reach 50 mmHg upper than baseline), followed by 5-minute intervals of reperfusion. In subjects presenting with BMI > 30 a dedicated blood pressure cuff for obese patients will be used. Coronary angiography will be performed in 45 minutes from last inflation |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- undergoing PCI with stenting for all clinical indications
- carrying (with) a renal clearance less than 60 mL/min/1.73 m2 and more than 30 mL/min/1.73 m2 (evaluated through MDRD); ù
- younger than 85 years old.
Key exclusion criteria (1 listed)
- ST Segment Elevation Myocardial Infarction (STEMI), unstable hemodynamic presentations (cardiogenic shock) or ongoing severe arrhythmias;
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 preconditioningfour times 5-minute inflations of a blood pressure cuff to 200 mmHg around the upper non dominant arm (or if systolic pressure is more than 150 mmHg, inflation will reach 50 mmHg up per than baseline), followed by 5-minute intervals of reperfusion. | Procedure or surgery | Remote ischemic preconditioning |
| Sham remote ischemic preconditioningIn the control group sham preconditioning will be performed with inflation of 10 mmHg more than baseline. | Procedure or surgery | Sham remote ischemic preconditioning' |
Primary outcome
Incidence of acute kidney injury
Time frame: 24 and 48 hours after PCI
Acute Kidney Injury defined as Acute kidney injury is defined as an increase serum creatinine greater than 0.5 mg/dL, or by a relative increase of at least 25% over the baseline value within a period of 48-hours after contrast medium administration
1 secondary outcome
Incidence of periprocedural myocardial infarction
Time frame: 24 and 48 hours after PCI
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 21 Jul 2014.
- Derived from this study: PubMed 34111564D'Ascenzo F, Femmino S, Ravera F, Angelini F, Caccioppo A, Franchin L, Grosso A, Comita S, Cavallari C, Penna C, De Ferrari GM, Camussi G, Pagliaro P, Brizzi MF. Extracellular vesicles from patients with Acute Coronary Syndrome impact on ischemia-reperfusion injury. Pharmacol Res. 2021 Aug;170:105715. doi: 10.1016/j.phrs.2021.105715. Epub 2021 Jun 7.
- Derived from this study: PubMed 29506674Moretti C, Cerrato E, Cavallero E, Lin S, Rossi ML, Picchi A, Sanguineti F, Ugo F, Palazzuoli A, Bertaina M, Presbitero P, Shao-Liang C, Pozzi R, Giammaria M, Limbruno U, Lefevre T, Gasparetto V, Garbo R, Omede P, Sheiban I, Escaned J, Biondi-Zoccai G, Gaita F, Perl L, D'Ascenzo F. The EUROpean and Chinese cardiac and renal Remote Ischemic Preconditioning Study (EURO-CRIPS CardioGroup I): A randomized controlled trial. Int J Cardiol. 2018 Apr 15;257:1-6. doi: 10.1016/j.ijcard.2017.12.033.
- our research website groupLink provided by the sponsor.
Related trials for Acute Kidney Injury
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
Recruiting
Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Remote ischemic preconditioning in people with Acute Kidney Injury, run by A.O.U. Città della Salute e della Scienza at 7 sites in 3 countries.
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 3 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: finished, as of the sponsor's last update on 21 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Italy, France, Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 acute kidney injury (time frame: 24 and 48 hours after PCI). 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 NCT02195726, which also lists 2 linked publications.
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 21 Jul 2014.