Assessment of ProEnkephalin to Detect Acute Kidney Injury (AKI) in Patients Hospitalized for Volume Overload Decompensated Chronic Heart Failure
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 18-000181
NCT ID: NCT04019314
Sponsor Protocol Number: 18-000181
About this study
The purpose of this study is to evaluate the baseline presence of plasma levels of biomarkers of renal injury and changes in these biomarkers during the course of in-hospital intravenous diuretic therapy can predict when threshold values that would indicate a clinically significant change in renal function that would warrant a change in diuretic therapy to occur.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- 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 Criteria:
- 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 state 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
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Paul McKie, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available