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

Primary Purpose

Aortic Valve Disease, Chronic Kidney Disease, Contrast Induced Nephropathy

Status

Unknown status

Phase

Phase 4

Locations

Netherlands

Study Type

Interventional

Intervention

sodium bicarbonate

hypotone saline

About this trial

This is an interventional prevention trial for Aortic Valve Disease focused on measuring transcatheter aortic valve implantation, transcatheter aortic valve replacement

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient has provided written informed consent.
Patient is undergoing TAVI.
Patient has an estimated GFR <60ml/min/1.73m2.

Exclusion Criteria:

Patient has end-stage kidney disease requiring dialysis.
Emergent TAVI (planned before next working day).
Recent exposure to radiographic contrast agents (within 2 days prior to the TAVI).
Allergy to contrast agent.
Planned administration of dopamine, mannitol, fenoldopam or N-acetylcysteine during the intended time of the study.
Need for continuous hydration therapy (e.g. sepsis).
Multiple myeloma.
Contra-indication to sodium bicarbonate.

Sites / Locations

St Antonius hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

sodium bicarbonate

hypotone saline

Arm Description

250ml 1.4% sodium bicarbonate 1 h before TAVR

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

Outcomes

Primary Outcome Measures

Contrast induced nephropathy

CIN is defined as an increase in Scr >0.5 mg/dL or 25% within 72 hours

Acute heart failure due to volume expansion

Secondary Outcome Measures

Composite of CIN or acute heart failure

Maximal relative change in serum creatinine

Acute kidney injury

According to AKIN classification

Need for dialysis

Need for blood transfusions

Number of blood transfusions

Length of hospital stay

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

Full Information

NCT ID

NCT03121053

First Posted

April 6, 2017

Last Updated

April 18, 2017

Sponsor

St. Antonius Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03121053

Brief Title

Preventing contrAst Induced Nephropathy After TranscathEter Aortic Valve Replacement

Acronym

PANTER

Official Title

Preventing Contrast Induced Nephropathy After Transcatheter Aortic Valve Replacement

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Unknown status

Study Start Date

October 2016 (undefined)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

January 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

St. Antonius Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

transcatheter aortic valve implantation, transcatheter aortic valve replacement

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

sodium bicarbonate

Arm Type

Active Comparator

Arm Description

250ml 1.4% sodium bicarbonate 1 h before TAVR

Arm Title

hypotone saline

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

sodium bicarbonate

Intervention Type

Drug

Intervention Name(s)

hypotone saline

Primary Outcome Measure Information:

Title

Contrast induced nephropathy

Description

CIN is defined as an increase in Scr >0.5 mg/dL or 25% within 72 hours

Time Frame

Day 3

Title

Acute heart failure due to volume expansion

Time Frame

Day 3

Secondary Outcome Measure Information:

Title

Composite of CIN or acute heart failure

Time Frame

Day 3

Title

Maximal relative change in serum creatinine

Time Frame

Day 3

Title

Acute kidney injury

Description

According to AKIN classification

Time Frame

Day 3

Title

Need for dialysis

Time Frame

Day 30

Title

Need for blood transfusions

Time Frame

Day 3 and Day 30

Title

Number of blood transfusions

Time Frame

Day 3 and Day 30

Title

Length of hospital stay

Time Frame

Day 30

Title

Recovery of renal function in CIN patients

Description

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

Time Frame

Day 30

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient has provided written informed consent. Patient is undergoing TAVI. Patient has an estimated GFR <60ml/min/1.73m2. Exclusion Criteria: Patient has end-stage kidney disease requiring dialysis. Emergent TAVI (planned before next working day). Recent exposure to radiographic contrast agents (within 2 days prior to the TAVI). Allergy to contrast agent. Planned administration of dopamine, mannitol, fenoldopam or N-acetylcysteine during the intended time of the study. Need for continuous hydration therapy (e.g. sepsis). Multiple myeloma. Contra-indication to sodium bicarbonate.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Vincent Nijenhuis, MD

Phone

+31 65 274 2486

v.nijenhuis@antoniusziekenhuis.nl

Facility Information:

Facility Name

St Antonius hospital

City

Nieuwegein

State/Province

Utrecht

ZIP/Postal Code

3435CM

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jan van der Heyden, MD, PhD

Phone

+31 30 609 27 74

jvdheijden@antoniusziekenhuis.nl

12. IPD Sharing Statement

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Preventing contrAst Induced Nephropathy After TranscathEter Aortic Valve Replacement

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