- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03121053
Preventing contrAst Induced Nephropathy After TranscathEter Aortic Valve Replacement (PANTER)
April 18, 2017 updated by: Jan van der Heyden, St. Antonius Hospital
Preventing Contrast Induced Nephropathy After Transcatheter Aortic Valve Replacement
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Vincent Nijenhuis, MD
- Phone Number: +31 65 274 2486
- Email: v.nijenhuis@antoniusziekenhuis.nl
Study Locations
-
-
Utrecht
-
Nieuwegein, Utrecht, Netherlands, 3435CM
- Recruiting
- St Antonius hospital
-
Contact:
- Jan van der Heyden, MD, PhD
- Phone Number: +31 30 609 27 74
- Email: jvdheijden@antoniusziekenhuis.nl
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: sodium bicarbonate
250ml 1.4% sodium bicarbonate 1 h before TAVR
|
|
ACTIVE_COMPARATOR: hypotone saline
0.65% sodiumchloride 1 ml/kg/h for 12 h before and 12 h after TAVR
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Contrast induced nephropathy
Time Frame: Day 3
|
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
Time Frame: Day 3
|
Day 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Composite of CIN or acute heart failure
Time Frame: Day 3
|
Day 3
|
|
Maximal relative change in serum creatinine
Time Frame: Day 3
|
Day 3
|
|
Acute kidney injury
Time Frame: Day 3
|
According to AKIN classification
|
Day 3
|
Need for dialysis
Time Frame: Day 30
|
Day 30
|
|
Need for blood transfusions
Time Frame: Day 3 and Day 30
|
Day 3 and Day 30
|
|
Number of blood transfusions
Time Frame: Day 3 and Day 30
|
Day 3 and Day 30
|
|
Length of hospital stay
Time Frame: Day 30
|
Day 30
|
|
Recovery of renal function in CIN patients
Time Frame: 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
|
Day 30
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2016
Primary Completion (ANTICIPATED)
December 1, 2018
Study Completion (ANTICIPATED)
January 1, 2019
Study Registration Dates
First Submitted
April 6, 2017
First Submitted That Met QC Criteria
April 18, 2017
First Posted (ACTUAL)
April 19, 2017
Study Record Updates
Last Update Posted (ACTUAL)
April 19, 2017
Last Update Submitted That Met QC Criteria
April 18, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PANTER_V1.1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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