Acute Kidney InjuryNCT04537325
Prevention of Acute Kidney Injury After Transcatheter Aortic Valve Implantation
A study testing RenalGuard system in people with Acute Kidney Injury, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
Randomized controlled, single-center trial randomizing patients with chronic kidney disease and symptomatic severe aortic valve stenosis undergoing transcatheter aortic valve implantation (TAVI). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- RenalGuard system
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteGermany
- Study dates
- 20 Jan 2017to 31 Aug 2020
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic severe aortic valve stenosis undergoing transcatheter aortic valve implantation
- Chronic kidney disease (baseline glomerular filtration rate ≤ 60 ml/min)
- Written informed consent
Who cannot join
- Hemodynamic instability
- Dialysis-dependent chronic kidney injury
- Emergency transcatheter aortic valve stenosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Acute Kidney Injury After Transcatheter Aortic Valve Implantation in Patients With Chronic Kidney Disease With Controlled Intravenous Hydration Matched to Urinary Output
Randomized controlled, single-center trial randomizing patients with chronic kidney disease and symptomatic severe aortic valve stenosis undergoing transcatheter aortic valve implantation (TAVI). Patients are randomized in a 1:1 ratio to periprocedural intravenous hydration matched to urine output using the RenalGuard system and to standard hydration. The purpose of the study is to test, wether the controlled intravenous hydration with the RenalGuard system is superior to standard hydration to prevent acute kidney injury after TAVI.
Read the detailed description
Acute kidney injury (AKI) after transcatheter aortic valve implantation (TAVI) is associated with worse outcome. The RenalGuard system was developed to prevent AKI by a controlled furosemide-induced diuresis with matched isotonic intravenous hydration. It is based on the theory, that a high urinary output prevents contrast media-induced nephropathy (CIN).
The present study is a prospective, randomized trial to investigate wether a matched intravenous hydration using the RenalGuard system is superior to standard pre- and postprocedural intravenous hydration in patients with severe aortic valve stenosis and chronic kidney disease undergoing TAVI. Primary endpoint is the occurrence of AKI after TAVI.
- Conditions
- Acute Kidney Injury
- Being tested
- RenalGuard system
- Keywords
- Transcatheter aortic valve stenosis, Chronic kidney disease, Acute kidney injury
- Medical subject headings
- Acute Kidney Injury, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RenalGuard systemDevice
Periprocedural intravenous hydration matched to urinary output.
| Study group | Role | What they receive |
|---|---|---|
| RenalGuard group | Active comparator | Not described Receives: Device: RenalGuard system |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute kidney injury
Increase of serum-creatinine of 0,3 mg/dl in pre-procedural serum-creatinine within 7 days after Transcatheter aortic valve implantation
Measured: Within 7 days after Transcatheter aortic valve implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start20 Jan 2017
- Primary completion16 Aug 2018
- Study completion31 Aug 2020
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.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe 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
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ulrich Schäfer, MD, Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04537325
- Sponsor's protocol ID
- AKI_TAVI
- Status last verified
- Mar 2021
- First submitted
- 29 Aug 2020
- Last updated
- 19 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hashimoto H, Yamada H, Murata M, Watanabe N. Diuretics for preventing and treating acute kidney injury. Cochrane Database Syst Rev. 2025 Jan 29;1(1):CD014937. doi: 10.1002/14651858.CD014937.pub2.
PubMed 39878152Voigtlander-Buschmann L, Schafer S, Schmidt-Lauber C, Weimann J, Shenas M, Giraldo Cortes J, Kuta PM, Zeller T, Twerenbold R, Seiffert M, Schofer N, Schneeberger Y, Schafer A, Schirmer J, Reichenspurner H, Blankenberg S, Conradi L, Schafer U. Effect of periprocedural furosemide-induced diuresis with matched isotonic intravenous hydration in patients with chronic kidney disease undergoing transcatheter aortic valve implantation. Clin Res Cardiol. 2024 Jun;113(6):801-811. doi: 10.1007/s00392-023-02234-z. Epub 2023 Jun 1.
PubMed 37264143
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Acute Kidney Injury After Transcatheter Aortic Valve Implantation in Patients With Chronic Kidney Disease With Controlled Intravenous Hydration Matched to Urinary Output
- ClinicalTrials.gov ID
- NCT04537325
- Acronym / sponsor ID
- AKI_TAVI
- Conditions
- Acute Kidney Injury
- Keywords
- Transcatheter aortic valve stenosis, Chronic kidney disease, Acute kidney injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 20 Jan 2017 (actual)
- Primary completion
- 16 Aug 2018 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 3 Sep 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.
Randomized controlled, single-center trial randomizing patients with chronic kidney disease and symptomatic severe aortic valve stenosis undergoing transcatheter aortic valve implantation (TAVI). Patients are randomized in a 1:1 ratio to periprocedural intravenous hydration matched to urine output using the RenalGuard system and to standard hydration. The purpose of the study is to test, wether the controlled intravenous hydration with the RenalGuard system is superior to standard hydration to prevent acute kidney injury after TAVI.
Detailed description
Acute kidney injury (AKI) after transcatheter aortic valve implantation (TAVI) is associated with worse outcome. The RenalGuard system was developed to prevent AKI by a controlled furosemide-induced diuresis with matched isotonic intravenous hydration. It is based on the theory, that a high urinary output prevents contrast media-induced nephropathy (CIN).
The present study is a prospective, randomized trial to investigate wether a matched intravenous hydration using the RenalGuard system is superior to standard pre- and postprocedural intravenous hydration in patients with severe aortic valve stenosis and chronic kidney disease undergoing TAVI. Primary endpoint is the occurrence of AKI after TAVI.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RenalGuard group | Active comparator | Device: RenalGuard system |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Symptomatic severe aortic valve stenosis undergoing transcatheter aortic valve implantation
- Chronic kidney disease (baseline glomerular filtration rate ≤ 60 ml/min)
- Written informed consent
Key exclusion criteria (3 listed)
- Hemodynamic instability
- Dialysis-dependent chronic kidney injury
- Emergency transcatheter aortic valve stenosis
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 |
|---|---|---|
| RenalGuard systemPeriprocedural intravenous hydration matched to urinary output. | Device | RenalGuard group |
Primary outcome
Acute kidney injury
Time frame: Within 7 days after Transcatheter aortic valve implantation
Increase of serum-creatinine of 0,3 mg/dl in pre-procedural serum-creatinine within 7 days after Transcatheter aortic valve implantation
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 19 Mar 2021.
- Derived from this study: PubMed 39878152Hashimoto H, Yamada H, Murata M, Watanabe N. Diuretics for preventing and treating acute kidney injury. Cochrane Database Syst Rev. 2025 Jan 29;1(1):CD014937. doi: 10.1002/14651858.CD014937.pub2.
- Derived from this study: PubMed 37264143Voigtlander-Buschmann L, Schafer S, Schmidt-Lauber C, Weimann J, Shenas M, Giraldo Cortes J, Kuta PM, Zeller T, Twerenbold R, Seiffert M, Schofer N, Schneeberger Y, Schafer A, Schirmer J, Reichenspurner H, Blankenberg S, Conradi L, Schafer U. Effect of periprocedural furosemide-induced diuresis with matched isotonic intravenous hydration in patients with chronic kidney disease undergoing transcatheter aortic valve implantation. Clin Res Cardiol. 2024 Jun;113(6):801-811. doi: 10.1007/s00392-023-02234-z. Epub 2023 Jun 1.
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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.
Ulrich Schäfer, MD principal investigator
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RenalGuard system in people with Acute Kidney Injury, run by Universitätsklinikum Hamburg-Eppendorf 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 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: finished, as of the sponsor's last update on 19 Mar 2021. 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?
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?
Acute kidney injury (time frame: Within 7 days after Transcatheter aortic valve implantation). 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 NCT04537325, 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 19 Mar 2021.