Preventing contrAst Induced Nephropathy After TranscathEter Aortic Valve Replacement

Chronic Kidney Disease Clinical Trial

— PANTER  

Official title:

Preventing Contrast Induced Nephropathy After Transcatheter Aortic Valve Replacement

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03121053
• Other study ID #: PANTER_V1.1
• Status: Recruiting
• Phase: Phase 4
• First received: April 6, 2017
• Last updated: April 18, 2017
• Start date: October 2016
• Est. completion date: January 2019

Study information

• Verified date: April 2017
• Source: St. Antonius Hospital
• Contact: Vincent Nijenhuis, MD
• Phone: +31 65 274 2486
• Email: v.nijenhuis[@]antoniusziekenhuis.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Aortic Valve Disease
• Chronic Kidney Disease
• Contrast Induced Nephropathy
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• sodium bicarbonate

• hypotone saline

Locations

Country	Name	City	State
Netherlands	St Antonius hospital	Nieuwegein	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
St. Antonius Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contrast induced nephropathy	CIN is defined as an increase in Scr >0.5 mg/dL or 25% within 72 hours	Day 3
Primary	Acute heart failure due to volume expansion		Day 3
Secondary	Composite of CIN or acute heart failure		Day 3
Secondary	Maximal relative change in serum creatinine		Day 3
Secondary	Acute kidney injury	According to AKIN classification	Day 3
Secondary	Need for dialysis		Day 30
Secondary	Need for blood transfusions		Day 3 and Day 30
Secondary	Number of blood transfusions		Day 3 and Day 30
Secondary	Length of hospital stay		Day 30
Secondary	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