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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03121053
Other study ID # PANTER_V1.1
Secondary ID
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
Health authority
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.

Study Design


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
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