Preventing contrAst Induced Nephropathy After TranscathEter Aortic Valve Replacement (PANTER)

St. Antonius Hospital

Status and phase: Unknown; Phase 4

Conditions: Chronic Kidney Disease; Acute Kidney Injury; Aortic Valve Disease; Contrast Induced Nephropathy

Treatments: Drug: hypotone saline; Drug: sodium bicarbonate

Study type: Interventional

Funder types: Other

Identifiers

NCT03121053

PANTER_V1.1

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

sodium bicarbonate

Active Comparator group

Description:

250ml 1.4% sodium bicarbonate 1 h before TAVR

Treatment:

Drug: sodium bicarbonate

hypotone saline

Active Comparator group

Description:

0.65% sodiumchloride 1 ml/kg/h for 12 h before and 12 h after TAVR

Treatment:

Drug: hypotone saline