Preventing contrAst Induced Nephropathy After TranscathEter Aortic Valve Replacement

NCT03121053 | Unknown Phase 4 DMC

• 1 other identifier: PANTER_V1.1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

transcatheter aortic valve implantation; transcatheter aortic valve replacement

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Composite of CIN or acute heart failure

  Day 3

• Maximal relative change in serum creatinine

  Day 3

• Acute kidney injury

  Day 3

• Need for dialysis

  Day 30

• Need for blood transfusions

  Day 3 and Day 30

Study Arms (2)

sodium bicarbonate

ACTIVE COMPARATOR

250ml 1.4% sodium bicarbonate 1 h before TAVR

Drug: sodium bicarbonate

hypotone saline

ACTIVE COMPARATOR

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

Drug: hypotone saline

Interventions

sodium bicarbonate DRUG

sodium bicarbonate

hypotone saline DRUG

hypotone saline

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Antonius Hospital: lead

Study Sites (1)

St Antonius hospital

Nieuwegein, Utrecht, 3435CM, Netherlands

RECRUITING

MeSH Terms

Conditions

Aortic Valve Disease; Renal Insufficiency, Chronic; Acute Kidney Injury

Interventions

Sodium Bicarbonate

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Vincent Nijenhuis, MD

CONTACT

+31 65 274 2486; v.nijenhuis@antoniusziekenhuis.nl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: April 19, 2017
• Study Start: October 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: January 1, 2019
• Last Updated: April 19, 2017

Record last verified: 2017-04

Locations

NL (1)