Preventing contrAst Induced Nephropathy After TranscathEter Aortic Valve Replacement

NCT ID: NCT03121053

Last Updated: 2017-04-19

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2019-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Aortic Valve Disease Chronic Kidney Disease Contrast Induced Nephropathy Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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sodium bicarbonate

250ml 1.4% sodium bicarbonate 1 h before TAVR

Group Type ACTIVE_COMPARATOR

sodium bicarbonate

Intervention Type DRUG

hypotone saline

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

Group Type ACTIVE_COMPARATOR

hypotone saline

Intervention Type DRUG

Interventions

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sodium bicarbonate

Intervention Type DRUG

hypotone saline

Intervention Type DRUG

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Antonius Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jan van der Heyden

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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St Antonius hospital

Nieuwegein, Utrecht, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Vincent Nijenhuis, MD

Role: CONTACT

+31 65 274 2486

Facility Contacts

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Jan van der Heyden, MD, PhD

Role: primary

+31 30 609 27 74

Other Identifiers

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PANTER_V1.1

Identifier Type: -

Identifier Source: org_study_id

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