To evaluate the efficacy of 250ml 1.4% sodium bicarbonate versus hypotone saline hydration prior to TAVI in patients with CKD to prevent CIN.
ID
Source
Brief title
Condition
- Cardiac valve disorders
- Nephropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Primary efficacy outcome is the development of contrast-induced nefropathy
(CIN).
2. Primary safety outcome is the development of acute heart failure due to
volume expansion.
Secondary outcome
1. Occurrence of the composite of CIN or acute heart failure due to volume
expansion.
2. Maximal relative change in serum creatinine measured between 0 and 72 h
post-TAVI compared with baseline.
3. Incidence of acute kidney injury, according to AKIN classification.
4. The need for dialysis.
5. The need for and number of blood transfusions.
6. Length of hospital stay.
7. 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]
Background 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. Prevention of contrast induced nephropathy (CIN) has not yet
been studied in these patients, and evidence on different strategies is
urgently needed.
Study objective
To evaluate the efficacy of 250ml 1.4% sodium bicarbonate versus hypotone
saline hydration prior to TAVI in patients with CKD to prevent CIN.
Study design
Randomized controlled trial.
Intervention
Random 1:1 allocation to sodium bicarbonate 250mL 1 h before TAVI versus
hypotone saline 1 ml/kg/h for 12 h before and 12 h after TAVI.
Study burden and risks
Follow-up is 30 days. We expect no physical and/or psychological discomfort
associated with participation.
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Listed location countries
Age
Inclusion criteria
1. Patient has provided written informed consent.
2. Patient is undergoing TAVI.
3. Patient has an estimated GFR <60ml/min/1.73m2.
Exclusion criteria
1. Patient has end-stage kidney disease requiring dialysis.
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2016-001919-20-NL |
| CCMO | NL57734.100.16 |