Aortic Valve DiseasePhase 4PANTERNCT03121053
Preventing contrAst Induced Nephropathy After TranscathEter Aortic Valve Replacement
A Phase 4 study testing sodium bicarbonate and hypotone saline in people with Aortic Valve Disease and Chronic Kidney Disease, run by St. Antonius Hospital at 1 site in Netherlands.
Trial summary
Chronic kidney disease (CKD) and (subsequent) acute kidney injury are frequent in patients undergoing transcatheter aortic valve implantation (TAVI). Moreover, these patients are easily hypervolemic and susceptible for cardiac decompensation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Valve Disease, Chronic Kidney Disease, Contrast Induced Nephropathy
- What is being tested?
- sodium bicarbonate and hypotone saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2016to Jan 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient has provided written informed consent.
- Patient is undergoing TAVI.
- Patient has an estimated GFR <60ml/min/1.73m2.
Who cannot join
- Patient has end-stage kidney disease requiring dialysis.
- Emergent TAVI (planned before next working day).
- Recent exposure to radiographic contrast agents (within 2 days prior to the TAVI).
- Allergy to contrast agent.
- Planned administration of dopamine, mannitol, fenoldopam or N-acetylcysteine during the intended time of the study.
- Need for continuous hydration therapy (e.g. sepsis).
- Multiple myeloma.
- Contra-indication to sodium bicarbonate.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
St Antonius hospital
Nieuwegein, Utrecht, 3435CM
Jan van der Heyden, MD, PhD, +31 30 609 27 74, jvdheijden@antoniusziekenhuis.nl
About this study
Official title: Preventing Contrast Induced Nephropathy After Transcatheter Aortic Valve Replacement
Chronic kidney disease (CKD) and (subsequent) acute kidney injury are frequent in patients undergoing transcatheter aortic valve implantation (TAVI). Moreover, these patients are easily hypervolemic and susceptible for cardiac decompensation. Prevention of contrast induced nephropathy (CIN) has not yet been studied in these patients, and evidence on different strategies is urgently needed. The objective of this study is to evaluate the efficacy of 250ml 1.4% sodium bicarbonate versus hypotone saline (0.65% sodiumchloride) hydration prior to TAVI in patients with CKD to prevent CIN.
- Conditions
- Aortic Valve Disease, Chronic Kidney Disease, Contrast Induced Nephropathy, Acute Kidney Injury
- Being tested
- sodium bicarbonate, hypotone saline
- Keywords
- transcatheter aortic valve implantation, transcatheter aortic valve replacement
- Medical subject headings
- Aortic Valve Disease, Renal Insufficiency, Chronic, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium bicarbonateDrug
hypotone salineDrug
| Study group | Role | What they receive |
|---|---|---|
| sodium bicarbonate | Active comparator | 250ml 1.4% sodium bicarbonate 1 h before TAVR Receives: Drug: sodium bicarbonate |
| hypotone saline | Active comparator | 0.65% sodiumchloride 1 ml/kg/h for 12 h before and 12 h after TAVR Receives: Drug: hypotone saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast induced nephropathy
CIN is defined as an increase in Scr >0.5 mg/dL or 25% within 72 hours
Measured: Day 3
Acute heart failure due to volume expansion
Measured: Day 3
Secondary outcomes (8)
Composite of CIN or acute heart failure
Measured: Day 3
Maximal relative change in serum creatinine
Measured: Day 3
Acute kidney injury
According to AKIN classification
Measured: Day 3
Need for dialysis
Measured: Day 30
Need for blood transfusions
Measured: Day 3 and Day 30
Number of blood transfusions
Measured: Day 3 and Day 30
Length of hospital stay
Measured: Day 30
Recovery of renal function in CIN patients
Recovery defined as an increase in serum creatinine <25% or <44 μmol/L (0.5 mg/dL) measured at 1 month post-TAVI compared with baseline
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study startOct 2016
- Primary completionDec 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve DiseaseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan van der Heyden, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03121053
- Sponsor's protocol ID
- PANTER_V1.1
- Acronym
- PANTER
- Status last verified
- Apr 2017
- First submitted
- 6 Apr 2017
- Last updated
- 19 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Contrast Induced Nephropathy After Transcatheter Aortic Valve Replacement
- ClinicalTrials.gov ID
- NCT03121053
- Acronym / sponsor ID
- PANTER / PANTER_V1.1
- Conditions
- Aortic Valve Disease, Chronic Kidney Disease, Contrast Induced Nephropathy, Acute Kidney Injury
- Keywords
- transcatheter aortic valve implantation, transcatheter aortic valve replacement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 19 Apr 2017 (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.
Chronic kidney disease (CKD) and (subsequent) acute kidney injury are frequent in patients undergoing transcatheter aortic valve implantation (TAVI). Moreover, these patients are easily hypervolemic and susceptible for cardiac decompensation. Prevention of contrast induced nephropathy (CIN) has not yet been studied in these patients, and evidence on different strategies is urgently needed. The objective of this study is to evaluate the efficacy of 250ml 1.4% sodium bicarbonate versus hypotone saline (0.65% sodiumchloride) hydration prior to TAVI in patients with CKD to prevent CIN.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sodium bicarbonate | Active comparator | Drug: sodium bicarbonate250ml 1.4% sodium bicarbonate 1 h before TAVR |
| hypotone saline | Active comparator | Drug: hypotone saline0.65% sodiumchloride 1 ml/kg/h for 12 h before and 12 h after TAVR |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patient has provided written informed consent.
- Patient is undergoing TAVI.
- Patient has an estimated GFR <60ml/min/1.73m2.
Key exclusion criteria (8 listed)
- Patient has end-stage kidney disease requiring dialysis.
- Emergent TAVI (planned before next working day).
- Recent exposure to radiographic contrast agents (within 2 days prior to the TAVI).
- Allergy to contrast agent.
- Planned administration of dopamine, mannitol, fenoldopam or N-acetylcysteine during the intended time of the study.
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 |
|---|---|---|
| sodium bicarbonate | Drug | sodium bicarbonate |
| hypotone saline | Drug | hypotone saline |
Primary outcome
Contrast induced nephropathy
Time frame: Day 3
CIN is defined as an increase in Scr >0.5 mg/dL or 25% within 72 hours
Acute heart failure due to volume expansion
Time frame: Day 3
8 secondary outcomes
Composite of CIN or acute heart failure
Time frame: Day 3
Maximal relative change in serum creatinine
Time frame: Day 3
Acute kidney injury
Time frame: Day 3
Need for dialysis
Time frame: Day 30
Need for blood transfusions
Time frame: Day 3 and Day 30
Number of blood transfusions
Time frame: Day 3 and Day 30
Length of hospital stay
Time frame: Day 30
Recovery of renal function in CIN patients
Time frame: Day 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2017.
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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 Phase 4 study testing sodium bicarbonate and hypotone saline in people with Aortic Valve Disease and Chronic Kidney Disease, run by St. Antonius Hospital at 1 site in Netherlands.
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 8 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 Apr 2017. 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 Netherlands. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vincent Nijenhuis, MD (+31 65 274 2486, v.nijenhuis@antoniusziekenhuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contrast induced nephropathy (time frame: Day 3). 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 Apr 2017.