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

Preventing Contrast Induced Nephropathy After Transcatheter Aortic Valve Replacement

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.

Study Overview

• Status: Unknown
• Conditions: Aortic Valve Disease; Chronic Kidney Disease; Acute Kidney Injury; Contrast Induced Nephropathy
• Intervention / Treatment: Drug: sodium bicarbonate; Drug: hypotone saline

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• Netherlands
  • Utrecht
    • Nieuwegein, Utrecht, Netherlands, 3435CM
      • Recruiting
      • St Antonius Hospital
      • Contact: Jan van der Heyden, MD, PhD; Phone Number: +31 30 609 27 74; Email: jvdheijden@antoniusziekenhuis.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: sodium bicarbonate; 250ml 1.4% sodium bicarbonate 1 h before TAVR	Drug: sodium bicarbonate
ACTIVE_COMPARATOR: hypotone saline; 0.65% sodiumchloride 1 ml/kg/h for 12 h before and 12 h after TAVR	Drug: hypotone saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: St. Antonius Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (ANTICIPATED): December 1, 2018
• Study Completion (ANTICIPATED): January 1, 2019

Study Registration Dates

• First Submitted: April 6, 2017
• First Submitted That Met QC Criteria: April 18, 2017
• First Posted (ACTUAL): April 19, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 19, 2017
• Last Update Submitted That Met QC Criteria: April 18, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: transcatheter aortic valve implantation; transcatheter aortic valve replacement
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Urologic Diseases; Renal Insufficiency; Heart Valve Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Acute Kidney Injury; Aortic Valve Disease
• Other Study ID Numbers: PANTER_V1.1