| Trial ID: | L1245 |
| Source ID: | NCT03121053
|
| Associated Drug: |
Sodium Bicarbonate
|
| Title: |
Preventing contrAst Induced Nephropathy After TranscathEter Aortic Valve Replacement
|
| Acronym: |
PANTER
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Aortic Valve Disease|Chronic Kidney Disease|Contrast Induced Nephropathy|Acute Kidney Injury
|
| Interventions: |
DRUG: sodium bicarbonate|DRUG: hypotone saline
|
| Outcome Measures: |
Primary: Contrast induced nephropathy, CIN is defined as an increase in Scr \>0.5 mg/dL or 25% within 72 hours, Day 3|Acute heart failure due to volume expansion, Day 3 | Secondary: Composite of CIN or acute heart failure, Day 3|Maximal relative change in serum creatinine, Day 3|Acute kidney injury, According to AKIN classification, Day 3|Need for dialysis, Day 30|Need for blood transfusions, Day 3 and Day 30|Number of blood transfusions, Day 3 and Day 30|Length of hospital stay, 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, Day 30
|
| Sponsor/Collaborators: |
Sponsor: St. Antonius Hospital
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
200
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
|
| Start Date: |
2016-10
|
| Completion Date: |
2019-01
|
| Results First Posted: |
|
| Last Update Posted: |
2017-04-19
|
| Locations: |
St Antonius hospital, Nieuwegein, Utrecht, 3435CM, Netherlands
|
| URL: |
https://clinicaltrials.gov/show/NCT03121053
|
