PANTER: Preventing contrAst Induced Nephropathy After TranscathEter Aortic Valve Replacement

Sponsor

St. Antonius Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03121053

Collaborator

(none)

200

Enrollment

Location

Arms

Duration (Months)

7.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Disease Chronic Kidney Disease Contrast Induced Nephropathy Acute Kidney Injury	Drug: sodium bicarbonate Drug: hypotone saline	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Preventing Contrast Induced Nephropathy After Transcatheter Aortic Valve Replacement

Study Start Date :

Oct 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2018

Anticipated Study Completion Date :

Jan 1, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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.