Induced Acute Kidney InjuryNCT04321148
Protect Kidney Trial
A study testing Impella-protected PCI in people with Induced Acute Kidney Injury and High-risk Percutaneous Coronary Intervention, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
This trial is a randomized, controlled, open-label, parallel study. Patients at high risk for contrast induced acute kidney injury (CI AKI) and planned high-risk percutaneous coronary intervention (PCI) will be randomized to receive optimal medical care for the prevention of CI AKI with periprocedural hydration either… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Induced Acute Kidney Injury, High-risk Percutaneous Coronary Intervention
- What is being tested?
- Impella-protected PCI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteGermany
- Study dates
- 24 Jan 2020to Dec 2023
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent obtained before any trial-related activities.
- Patients aged 18-85 years (both inclusive) with clinical indication for coronary angiogram with potential high-risk PCI
- Patients at high risk for contrast induced acute kidney injury as indicated by a preliminary Mehran Score ≥ 10 (contrast media volume is assumed to be < 100 ml)
Who cannot join
- Previous participation in this trial. Participation is defined as randomized.
- Patients with contraindications to use of an Impella heart pump (mural thrombus in the left ventricle; presence of a mechanical aortic valve or aortic valve stenosis (equivalent orifice area of 1.5 cm2 or less); moderate to severe aortic insufficiency (echocardiographic assessment graded as ≥ +2); in whom severe peripheral arterial disease precluding placement of an Impella system)
- Patients where hemodynamic support is deemed potentially required for PCI as assessed by at least one physician
- Patients needing emergency percutaneous coronary intervention (e.g. STEMI patients)
- Patients with acute cardiogenic shock indicated by one of the following:
- Systolic blood pressure < 90mmHg over 30 minutes or inotropic support needed to maintain blood pressure targets.
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- Killip class III \& IV
- MCS already in place to maintain blood pressure and organ perfusion
- Patients with on-going resuscitation
- Unwitnessed cardiac arrest OR ≥30 minutes of CPR prior to screening OR any impairment in mental status, cognition, or any global or focal neurological deficit
- Patients on mechanical ventilation.
- Patients diagnosed with AKI within the last seven days prior to screening or incipient AKI. (In cases, where AKI cannot be ruled out as a cause for elevated serum creatine, a rise or fall above 30% of a second serum creatinine measurement obtained within 12 to 24 hours is indicative of AKI)
- Patients with an eGFR < 20 ml/min/1.73 m²
- Suspected or known pregnancy
- Patients with comorbidity that in the Investigator's opinion would limit life expectancy to less than 6 months
- Patients with other medical, social, or psychological problems that, in the opinion of the Investigator, preclude them from undergoing Impella-protected PCI or the study-related procedures, evaluations, and follow-up.
- Patients with severe anemia as indicated by hemoglobin concentrations < 8.5 g/dl at the time of screening.
- Patients who were exposed to contrast media in the last seven days prior to the time of screening
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
- Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device which has not reached its primary end point.
- Patients with contraindications against MRI-procedures (e.g. patients with pacemakers) are eligible for the study but will not participate in the BOLD-MRI assessment.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Heinrich-Heine-University, Div. of Cardiology, Pulmonary Disease and Vascular Medicine
Düsseldorf, North Rhine-Westphalia, 40225
Ralf Westenfeld, MD, +49 211 81 18800, ralf.westenfeld@med.uni-duesseldorf.de
M.A.
About this study
Official title: Prospective Randomized Study Comparing Impella Support Plus Optimal Medical Care Versus Optimal Medical Care Alone in Patients at High Risk for Contrast-induced Nephropathy Undergoing Elective Percutaneous Revascularization
This trial is a randomized, controlled, open-label, parallel study. Patients at high risk for contrast induced acute kidney injury (CI AKI) and planned high-risk percutaneous coronary intervention (PCI) will be randomized to receive optimal medical care for the prevention of CI AKI with periprocedural hydration either in combination with or without use of an Impella device during PCI. Renal function will be assessed over 6 months, potential complications (in particular bleeding and access site complications) over one month. Effects of device-assisted PCI on pathways for salt and water handling, as well as on kidney oxygenation will be detected by sequential sampling of blood and urine as well as detection of magnetic resonance imaging indicative of blood kidney oxygenation (BOLD MRI).
- Being tested
- standard of care PCI, Impella-protected PCI
- Keywords
- induced acute kidney injury, high-risk percutaneous coronary intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard of care PCIProcedure or surgery
optimal medical care PCI
Impella-protected PCIProcedure or surgery
Impella-protected PCI
| Study group | Role | What they receive |
|---|---|---|
| standard of care PCI | Other | Not described Receives: Procedure: standard of care PCI |
| Impella-protected PCI | Experimental | Not described Receives: Procedure: Impella-protected PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of Contrast-induced acute kidney injury (CI-AKI)
Incidence rate of AKI (Acute Kidney Injury Criteria 1-3) over 2 days after PCI
Measured: 2 days after PCI
Secondary outcomes (6)
Change in eGFR
Measured: at day 1 and day 3 from baseline (pre-PCI)
Incidence of acute kidney injury (AKIN Criteria 1-3)
Measured: over 3 days after PCI
Incidence of dialysis
Incidence of dialysis during hospitalization and over 6 months after PCI
Measured: up to 6 months after PCI
Incidence of re-hospitalization for renal dysfunction
Incidence of re-hospitalization for renal dysfunction over 30 days and 6 months after PCI
Measured: 30 days and up to 6 months after PCI
Mortality
Mortality during hospital stay and over 6 months after PCI
Measured: up to 6 months after PCI
Length of hospital stay
Measured: up to 3 days after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start24 Jan 2020
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- None (open label)
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Collaborators
- Profil Clinical Trials Coordination GmbH, Abiomed Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04321148
- Sponsor's protocol ID
- 18-018
- Status last verified
- Nov 2022
- First submitted
- 16 Mar 2020
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study Comparing Impella Support Plus Optimal Medical Care Versus Optimal Medical Care Alone in Patients at High Risk for Contrast-induced Nephropathy Undergoing Elective Percutaneous Revascularization
- ClinicalTrials.gov ID
- NCT04321148
- Acronym / sponsor ID
- 18-018
- Keywords
- induced acute kidney injury, high-risk percutaneous coronary intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Collaborators
- Profil Clinical Trials Coordination GmbH, Abiomed Inc.
- Study start
- 24 Jan 2020 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 25 Mar 2020 (actual)
- 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.
This trial is a randomized, controlled, open-label, parallel study. Patients at high risk for contrast induced acute kidney injury (CI AKI) and planned high-risk percutaneous coronary intervention (PCI) will be randomized to receive optimal medical care for the prevention of CI AKI with periprocedural hydration either in combination with or without use of an Impella device during PCI. Renal function will be assessed over 6 months, potential complications (in particular bleeding and access site complications) over one month. Effects of device-assisted PCI on pathways for salt and water handling, as well as on kidney oxygenation will be detected by sequential sampling of blood and urine as well as detection of magnetic resonance imaging indicative of blood kidney oxygenation (BOLD MRI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard of care PCI | Other | Procedure: standard of care PCI |
| Impella-protected PCI | Experimental | Procedure: Impella-protected PCI |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed and dated informed consent obtained before any trial-related activities.
- Patients aged 18-85 years (both inclusive) with clinical indication for coronary angiogram with potential high-risk PCI
- Patients at high risk for contrast induced acute kidney injury as indicated by a preliminary Mehran Score ≥ 10 (contrast media volume is assumed to be < 100 ml)
Key exclusion criteria (21 listed)
- Previous participation in this trial. Participation is defined as randomized.
- Patients with contraindications to use of an Impella heart pump (mural thrombus in the left ventricle; presence of a mechanical aortic valve or aortic valve stenosis (equivalent orifice area of 1.5 cm2 or less); moderate to severe aortic insufficiency (echocardiographic assessment graded as ≥ +2); in whom severe peripheral arterial disease precluding placement of an Impella system)
- Patients where hemodynamic support is deemed potentially required for PCI as assessed by at least one physician
- Patients needing emergency percutaneous coronary intervention (e.g. STEMI patients)
- Patients with acute cardiogenic shock indicated by one of the following:
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 |
|---|---|---|
| standard of care PCIoptimal medical care PCI | Procedure or surgery | standard of care PCI |
| Impella-protected PCIImpella-protected PCI | Procedure or surgery | Impella-protected PCI |
Primary outcome
Incidence rate of Contrast-induced acute kidney injury (CI-AKI)
Time frame: 2 days after PCI
Incidence rate of AKI (Acute Kidney Injury Criteria 1-3) over 2 days after PCI
6 secondary outcomes
Change in eGFR
Time frame: at day 1 and day 3 from baseline (pre-PCI)
Incidence of acute kidney injury (AKIN Criteria 1-3)
Time frame: over 3 days after PCI
Incidence of dialysis
Time frame: up to 6 months after PCI
Incidence of re-hospitalization for renal dysfunction
Time frame: 30 days and up to 6 months after PCI
Mortality
Time frame: up to 6 months after PCI
Length of hospital stay
Time frame: up to 3 days after PCI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Impella-protected PCI in people with Induced Acute Kidney Injury and High-risk Percutaneous Coronary Intervention, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
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 21 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 7 Nov 2022. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ralf Westenfeld, MD (+2118118800, ctu@med.uni-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of Contrast-induced acute kidney injury (CI-AKI) (time frame: 2 days after PCI). 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 7 Nov 2022.