Preventing contrAst Induced Nephropathy After TranscathEter Aortic Valve Replacement
NCT ID: NCT03121053
Last Updated: 2017-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
200 participants
INTERVENTIONAL
2016-10-31
2019-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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sodium bicarbonate
250ml 1.4% sodium bicarbonate 1 h before TAVR
sodium bicarbonate
hypotone saline
0.65% sodiumchloride 1 ml/kg/h for 12 h before and 12 h after TAVR
hypotone saline
Interventions
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sodium bicarbonate
hypotone saline
Eligibility Criteria
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Inclusion Criteria
2. Patient is undergoing TAVI.
3. Patient has an estimated GFR \<60ml/min/1.73m2.
Exclusion Criteria
2. Emergent TAVI (planned before next working day).
3. Recent exposure to radiographic contrast agents (within 2 days prior to the TAVI).
4. Allergy to contrast agent.
5. Planned administration of dopamine, mannitol, fenoldopam or N-acetylcysteine during the intended time of the study.
6. Need for continuous hydration therapy (e.g. sepsis).
7. Multiple myeloma.
8. Contra-indication to sodium bicarbonate.
ALL
No
Sponsors
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St. Antonius Hospital
OTHER
Responsible Party
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Jan van der Heyden
Principal Investigator
Locations
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St Antonius hospital
Nieuwegein, Utrecht, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PANTER_V1.1
Identifier Type: -
Identifier Source: org_study_id
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