Chronic Kidney DiseasesNCT06599424
IntraRenal HEmoDynamics to IntegraTE CA-AKI Risk and Monitor NephroprotectiIoN by ImpElla Support.
An observational study of Chronic Kidney Diseases and Renal Failure, run by Heinrich-Heine University, Duesseldorf at 2 sites in Germany.
Trial summary
the hypothesis is that elevation of the intrarenal resistive index (RI) characterizes patients at elevated risk for subsequent CA-AKI and integrates items of the Mehran AKI risk score into a single, readily obtainable parameter. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Kidney Diseases, Renal Failure, Coronary Artery Disease
- What is being tested?
- Observational
- How many people
- 550 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Oct 2023to Jun 2025
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with indication for PCI or Impella-protected PCI
Who may be able to join
- Subjects must meet all of the Inclusion Criteria to participate in the trial.
- Age ≥18 years and <90 years
- Scheduled for PCI or PROTECTED PCI in near future (1 week) or PCI same day.
Who cannot join
- Subjects must NOT meet any of the following Exclusion Criteria to participate in the trial.
- Severe chronic kidney disease with eGFR ≤ 20 ml/min or on dialysis
- Patients with AKI within the last seven days prior screening or incipient AKI (in cases, where AKI cannot be ruled out as a cause for elevated serum creatinine, a rise or fall above 30% of a second serum creatinine measurement obtained within 12 to 24 hours is regarded indicative of AKI).
- STEMI ≤24 hours from the onset of ischemic symptoms or at any time if mechanical complications of transmural infarction are present (e.g., VSD, papillary muscle rupture, etc.)
- Cardiogenic shock (SBP <80 mmHg for ≥30 mins and not responsive to intravenous fluids or hemodynamic deterioration for any duration requiring pressors or mechanical circulatory support, including IABP)
- Cardiorespiratory arrest related to the current admission unless subject is extubated for >24 hours with full neurologic recovery and hemodynamically stable.
Show all 12Show fewer
- Platelet count <75,000 cells/mm3, bleeding diathesis or active bleeding, coagulopathy or unwilling to receive blood transfusions.
- Pregnant or child-bearing potential unless negative pregnancy test within 1 week
- Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device that has not reached its primary endpoint
- Any medical or psychiatric condition such as dementia, alcoholism or substance abuse which may preclude informed consent or interfere with any of the study procedures, including follow-up visits
- Any non-cardiac condition with life expectancy <1 years (e.g., cirrhosis, cancer not in remission, etc.)
- Subject belongs to a vulnerable population (defined as individuals with mental disability, persons in nursing homes, impoverished persons, homeless persons, nomads, refugees and those permanently incapable of giving informed consent; vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces and persons kept in detention)
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
Department of Cardiology, Angiology and Intensive Care Medicine Campus at German Heart Center Charite
Berlin
Carsten Skurk, Prof., +49 (0) 30 - 450 513702, carsten.skurk@charite.de
- Recruiting
Division of Cardiology, Pulmonary Disease and Vascular Medicine at University Hospital Duesseldorf
Düsseldorf, 40225
Amin Polzin, Prof., +49211-81-18800, Amin.Polzin@med.uni-duesseldorf.de
Lisa Dannenberg, PD, +49211-81-05315, LisaKristina.Dannenberg@med.uni-duesseldorf.de
About this study
the hypothesis is that elevation of the intrarenal resistive index (RI) characterizes patients at elevated risk for subsequent CA-AKI and integrates items of the Mehran AKI risk score into a single, readily obtainable parameter. Impella-mediated nephroprotection confers to reduction of elevated RI by restoration of intrarenal venous flow profile.
Read the detailed description
Contrast-associated acute kidney injury (CA-AKI) occurs in up to 10% of patients undergoing percutaneous coronary intervention (PCI) for coronary revascularization. CA-AKI is associated with impaired long-term outcome. This causes so-called "Renalism", describing the fact that patients with chronic kidney disease (CKD) in need of live-saving revascularizations are not offered PCI procedures in the risk of imminent CA-AKI.
Retrospective studies and one-single-center pilot study described protective effects of Impella-protected PCI to reduce the incidence of CA-AKI. However, mechanisms involved of nephroprotection by Impella remain obscure. Deciphering these, is a prerequisite to tailor nephroprotection to the patients in need and to gain a label for nephroprotection by Impella.
- Being tested
- Observational
- Keywords
- CKD, CAD, AKI, nephroprotection, impella, protected PCI
- Medical subject headings
- Renal Insufficiency, Chronic, Renal Insufficiency, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Observational
| Study group | Role | What they receive |
|---|---|---|
| subjects with PCI | Not described Receives: Other: Observational | |
| subjectis with Impella-protected PCI | Not described Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intrarenal Resistive Index (RI)
unitless, sonographic index measured in intrarenal arteries defined as (peak systolic velocity - end-diastolic velocity ) / peak systolic velocity.
Measured: immediately and 24 hours after PCI
Acute Kidney Injury
Increase in serum creatinine by at least 0.3 mg/dl within 48 hours, or increase in serum creatinine at least 1.5 times the known or assumed baseline value within seven days
Measured: 48 hours respectively within 7 days
Secondary outcomes (7)
Serum creatinine (mg/dl) and calculated creatinine clearance (ml/min) in relation to RI (Intrarenal Resistive Index) an Mehran score (unitiles)
Relation calculated by Pearson correlation
Measured: maximum change 24 hours post intervention compared to baseline
α2macroglobulin urine concentration in relation to RI and Mehran score (unitiless).
Relation calculated by Pearson correlation
Measured: maximum change 24 hours post intervention compared to baseline
NGAL urine concentration (ng/ml) in subgroup analysis in relation to RI and mehran score (unitless);
Relation calculated by Pearson correlation
Measured: maximum change 24 hours post intervention compared to baseline
Reclassification of AKI Risk by determined cutoff value for RI compared to classic Mehran score
Measured: maximum change day 1 or day 2 post intervention compared to baseline
Length of stay in relation to RI and classic Mehran score.
Measured: Hospital admission until discharge (assessed up to maximum of 10 days)
Hierarchical clinical endpoint of AKI > rise of urinary α2macroglobulin concentration post PCI > increase of RI post PCI in Impella-protected patients versus non-Impella-protected patients matched by Mehran score
Measured: maximum change day 1 or day 2 post intervention compared to baseline
Change of RI (Intrarenal Resistive Index) by Impella comparing RI at performance levels P0 and P9 at the begin of the intervention in every Impella-protected patient.
Measured: during Impella treatment (up to 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2023
- Primary completionOct 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Collaborators
- German Heart Center, Charite University, Berlin, Germany
- Responsible party
- Sponsor
- Investigators
- Malte Kelm, Prof., Study chair, Division of Cardiology, Pulmonary Disease and Vascular MedicineAmin Polzin, Prof., Principal investigator, Division of Cardiology, Pulmonary Disease and Vascular Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06599424
- Sponsor's protocol ID
- REDETERMINE
- Status last verified
- May 2024
- First submitted
- 2 May 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IntraRenal HEmoDynamics to IntegraTE CA-AKI Risk and Monitor NephroprotectiIoN by ImpElla Support.
- ClinicalTrials.gov ID
- NCT06599424
- Acronym / sponsor ID
- REDETERMINE
- Keywords
- CKD, CAD, AKI, nephroprotection, impella, protected PCI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Collaborators
- German Heart Center, Charite University, Berlin, Germany
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 19 Sep 2024 (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.
the hypothesis is that elevation of the intrarenal resistive index (RI) characterizes patients at elevated risk for subsequent CA-AKI and integrates items of the Mehran AKI risk score into a single, readily obtainable parameter. Impella-mediated nephroprotection confers to reduction of elevated RI by restoration of intrarenal venous flow profile.
Detailed description
Contrast-associated acute kidney injury (CA-AKI) occurs in up to 10% of patients undergoing percutaneous coronary intervention (PCI) for coronary revascularization. CA-AKI is associated with impaired long-term outcome. This causes so-called "Renalism", describing the fact that patients with chronic kidney disease (CKD) in need of live-saving revascularizations are not offered PCI procedures in the risk of imminent CA-AKI.
Retrospective studies and one-single-center pilot study described protective effects of Impella-protected PCI to reduce the incidence of CA-AKI. However, mechanisms involved of nephroprotection by Impella remain obscure. Deciphering these, is a prerequisite to tailor nephroprotection to the patients in need and to gain a label for nephroprotection by Impella.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| subjects with PCI | – | Other: Observational |
| subjectis with Impella-protected PCI | – | Other: Observational |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with indication for PCI or Impella-protected PCI
Key inclusion criteria (3 listed)
- Subjects must meet all of the Inclusion Criteria to participate in the trial.
- Age ≥18 years and <90 years
- Scheduled for PCI or PROTECTED PCI in near future (1 week) or PCI same day.
Key exclusion criteria (12 listed)
- Subjects must NOT meet any of the following Exclusion Criteria to participate in the trial.
- Severe chronic kidney disease with eGFR ≤ 20 ml/min or on dialysis
- Patients with AKI within the last seven days prior screening or incipient AKI (in cases, where AKI cannot be ruled out as a cause for elevated serum creatinine, a rise or fall above 30% of a second serum creatinine measurement obtained within 12 to 24 hours is regarded indicative of AKI).
- STEMI ≤24 hours from the onset of ischemic symptoms or at any time if mechanical complications of transmural infarction are present (e.g., VSD, papillary muscle rupture, etc.)
- Cardiogenic shock (SBP <80 mmHg for ≥30 mins and not responsive to intravenous fluids or hemodynamic deterioration for any duration requiring pressors or mechanical circulatory support, including IABP)
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 |
|---|---|---|
| ObservationalObservational | Other | subjectis with Impella-protected PCI, subjects with PCI |
Primary outcome
Intrarenal Resistive Index (RI)
Time frame: immediately and 24 hours after PCI
unitless, sonographic index measured in intrarenal arteries defined as (peak systolic velocity - end-diastolic velocity ) / peak systolic velocity.
Acute Kidney Injury
Time frame: 48 hours respectively within 7 days
Increase in serum creatinine by at least 0.3 mg/dl within 48 hours, or increase in serum creatinine at least 1.5 times the known or assumed baseline value within seven days
7 secondary outcomes
Serum creatinine (mg/dl) and calculated creatinine clearance (ml/min) in relation to RI (Intrarenal Resistive Index) an Mehran score (unitiles)
Time frame: maximum change 24 hours post intervention compared to baseline
α2macroglobulin urine concentration in relation to RI and Mehran score (unitiless).
Time frame: maximum change 24 hours post intervention compared to baseline
NGAL urine concentration (ng/ml) in subgroup analysis in relation to RI and mehran score (unitless);
Time frame: maximum change 24 hours post intervention compared to baseline
Reclassification of AKI Risk by determined cutoff value for RI compared to classic Mehran score
Time frame: maximum change day 1 or day 2 post intervention compared to baseline
Length of stay in relation to RI and classic Mehran score.
Time frame: Hospital admission until discharge (assessed up to maximum of 10 days)
Hierarchical clinical endpoint of AKI > rise of urinary α2macroglobulin concentration post PCI > increase of RI post PCI in Impella-protected patients versus non-Impella-protected patients matched by Mehran score
Time frame: maximum change day 1 or day 2 post intervention compared to baseline
Change of RI (Intrarenal Resistive Index) by Impella comparing RI at performance levels P0 and P9 at the begin of the intervention in every Impella-protected patient.
Time frame: during Impella treatment (up to 14 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- 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.
Malte Kelm, Prof. study chair
Division of Cardiology, Pulmonary Disease and Vascular Medicine
Amin Polzin, Prof. principal investigator
Division of Cardiology, Pulmonary Disease and Vascular Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases and Renal Failure, run by Heinrich-Heine University, Duesseldorf at 2 sites 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 12 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Amin Polzin, Prof. (+49211-81-18800, Amin.Polzin@med.uni-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intrarenal Resistive Index (RI) (time frame: immediately and 24 hours after PCI). The study lists 2 primary outcomes in all. 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 19 Sep 2024.