Status:
COMPLETED
Assessment of ProEnkephalin to Detect Acute Kidney Injury (AKI)
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Sphingotec GmbH
Conditions:
Heart Failure
Volume Overload
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Researchers are observing the values of proEnkephalin (PENK) via a blood draw in hospitalized patients that are volume overloaded requiring diuresis. If changes in PENK are found, physicians may predi...
Detailed Description
The purpose of this study will be to probe if values of proEnkephalin, called PENK in this proposal, can identify those patients who develop AKI. This biomarker is an opioid that is rapidly released i...
Eligibility Criteria
Inclusion
- Age \> 18 years
- LVEF \<50% measured within 6 months of index hospitalization
- Clinically identified volume overload with at least one sign of volume overload (pre-admission fluid weight gain, edema, increased DOE, PND, orthopnea, JVD on examination) and a need for intravenous diuretic therapy
Exclusion
- Baseline sCr \>3.0mg/dL and K+ \<3.0 and \>5.5mEq/L
- Hemoglobin \< 9.0g/dL
- Systemic systolic blood pressure consistently \<100mm Hg
- Patients being treated with hemodialysis, CKD stage 5 or s/p renal transplantation
- S/P cardiac transplant or LVAD implantation/total artificial heart
- Pregnancy or of child bearing potential
- Allergy to iodine
- Unable to provide informed consent to participate in the study
Key Trial Info
Start Date :
June 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 6 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04019314
Start Date
June 11 2019
End Date
October 6 2021
Last Update
August 23 2022
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905