Preventing contrAst Induced Nephropathy After TranscathEter Aortic Valve Replacement

NCT03121053 — Phase 4, Unknown, 200 participants, St. Antonius Hospital

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Preventing Contrast Induced Nephropathy After Transcatheter Aortic Valve Replacement

Registry	NCT03121053, acronym PANTER
Status	Unknown
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: none, prevention
Enrollment	200 (Estimated)
Sponsor	St. Antonius Hospital (Other)
Conditions	Aortic Valve Disease, Chronic Kidney Disease, Contrast Induced Nephropathy, Acute Kidney Injury
Interventions	sodium bicarbonate, hypotone saline (Drug)
Dates	start 2016-10-01, primary completion 2018-12-01 (estimated), completion 2019-01-01 (estimated), first posted 2017-04-19, last updated 2017-04-19
Locations	1 site in Netherlands

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
sodium bicarbonate	Active comparator	Drug: sodium bicarbonate	250ml 1.4% sodium bicarbonate 1 h before TAVR
hypotone saline	Active comparator	Drug: hypotone saline	0.65% sodiumchloride 1 ml/kg/h for 12 h before and 12 h after TAVR

sodium bicarbonate (Drug)
hypotone saline (Drug)

+Outcome measures

Primary outcomes

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 outcomes

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

Sex: All

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.

+Locations (1)

Facility	City	Country	Status
St Antonius hospital	Nieuwegein, Utrecht	Netherlands	Recruiting

My Notes

Public

To Read Reading Read