Preventing contrAst Induced Nephropathy After TranscathEter Aortic Valve Replacement

Phase 4

• Conditions: Aortic Valve Disease; Chronic Kidney Disease; Contrast Induced Nephropathy; Acute Kidney Injury
• Interventions: Drug: hypotone saline; Drug: sodium bicarbonate

• Registration Number: NCT03121053
• Lead Sponsor: St. Antonius Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10
• Status Verified: 2017-04
• Study First Submitted: 2017-04-06
• Study First Submitted QC: 2017-04-18
• Last Update Submitted: 2017-04-18
• Study First Posted: 2017-04-19
• Last Update Posted: 2017-04-19
• Primary Completion: 2018-12
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hypotone saline	hypotone saline	0.65% sodiumchloride 1 ml/kg/h for 12 h before and 12 h after TAVR
sodium bicarbonate	sodium bicarbonate	250ml 1.4% sodium bicarbonate 1 h before TAVR

Primary Outcome Measures

Name	Time	Method
Contrast induced nephropathy	Day 3	CIN is defined as an increase in Scr \>0.5 mg/dL or 25% within 72 hours
Acute heart failure due to volume expansion	Day 3

Secondary Outcome Measures

Name	Time	Method
Composite of CIN or acute heart failure	Day 3
Maximal relative change in serum creatinine	Day 3
Acute kidney injury	Day 3	According to AKIN classification
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	Day 30	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

Trial Locations

Locations (1)

St Antonius hospital; 🇳🇱 Nieuwegein, Utrecht, Netherlands