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Preventing contrAst Induced Nephropathy After TranscathEter Aortic Valve Replacement (PANTER)

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ClinicalTrials.gov Identifier: NCT03121053
Recruitment Status : Unknown
Verified April 2017 by Jan van der Heyden, St. Antonius Hospital.
Recruitment status was:  Recruiting
First Posted : April 19, 2017
Last Update Posted : April 19, 2017
Sponsor:
Information provided by (Responsible Party):
Jan van der Heyden, 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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

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



Primary Outcome Measures :
  1. Contrast induced nephropathy [ Time Frame: Day 3 ]
    CIN is defined as an increase in Scr >0.5 mg/dL or 25% within 72 hours

  2. Acute heart failure due to volume expansion [ Time Frame: Day 3 ]

Secondary Outcome Measures :
  1. Composite of CIN or acute heart failure [ Time Frame: Day 3 ]
  2. Maximal relative change in serum creatinine [ Time Frame: Day 3 ]
  3. Acute kidney injury [ Time Frame: Day 3 ]
    According to AKIN classification

  4. Need for dialysis [ Time Frame: Day 30 ]
  5. Need for blood transfusions [ Time Frame: Day 3 and Day 30 ]
  6. Number of blood transfusions [ Time Frame: Day 3 and Day 30 ]
  7. Length of hospital stay [ Time Frame: Day 30 ]
  8. 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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03121053


Contacts
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Contact: Vincent Nijenhuis, MD +31 65 274 2486 v.nijenhuis@antoniusziekenhuis.nl

Locations
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Netherlands
St Antonius hospital Recruiting
Nieuwegein, Utrecht, Netherlands, 3435CM
Contact: Jan van der Heyden, MD, PhD    +31 30 609 27 74    jvdheijden@antoniusziekenhuis.nl   
Sponsors and Collaborators
St. Antonius Hospital
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Responsible Party: Jan van der Heyden, Principal Investigator, St. Antonius Hospital
ClinicalTrials.gov Identifier: NCT03121053    
Other Study ID Numbers: PANTER_V1.1
First Posted: April 19, 2017    Key Record Dates
Last Update Posted: April 19, 2017
Last Verified: April 2017
Keywords provided by Jan van der Heyden, St. Antonius Hospital:
transcatheter aortic valve implantation
transcatheter aortic valve replacement
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Acute Kidney Injury
Urologic Diseases
Renal Insufficiency