Assessment of ProEnkephalin to Detect Acute Kidney Injury (AKI)

Sponsor
Mayo Clinic (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04019314
Collaborator
Sphingotec GmbH (Industry)
20
Enrollment
1
Location
1
Arm
37.6
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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 predict values of change in kidney function during treatment.

Condition or DiseaseIntervention/TreatmentPhase
  • Procedure: Blood Collection
  • Procedure: Blood Volume Analysis
N/A

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 in response to renal injury. At a cut-off value of 100pmol/L, it has been reported to have excellent sensitivity and specificity for detecting renal injury. PENK has been shown to be prognostic of WRF and outcomes in patients with acute heart failure but requires evaluation of efficacy in detecting AKI in standard of care clinical practice settings. In this study we propose to evaluate the baseline presence of plasma and/or serum levels of biomarkers of renal injury and changes in these biomarkers during the course of in-hospital intravenous diuretic therapy. The question is if threshold values of the biomarkers can be identified and if those threshold values would indicate a clinically significant change in renal function that would warrant a change in diuretic therapy to occur. In this context the quantitative assessment of intravascular volume will provide objective corroboration as to volume status in relation to biomarker levels and changes during treatment. If this approach can be proven to be fruitful, it would be anticipated that a subsequent study, a clinical trial, to test the hypothesis that biomarkers of AKI, specifically PENK, could be used to identify and avoid AKI in hospitalized patients with decompensated HF.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Assessment of ProEnkephalin to Detect Acute Kidney Injury (AKI) in Patients Hospitalized for Volume Overload Decompensated Chronic Heart Failure
Actual Study Start Date :
Jun 11, 2019
Anticipated Primary Completion Date :
Jul 30, 2022
Anticipated Study Completion Date :
Jul 30, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: Subjects with know chronic systolic heart failure

Subjects with know chronic systolic heart failure (LVEF<50%) admitted to SMH Heart Failure Medical Service for decompensated HF with clinical findings of volume overload requiring advanced diuretic therapy intervention and management will receive daily blood draws and quantitative blood volume analysis

Procedure: Blood Collection
Samples for proEnkephalin PENK will be obtained daily and aliquots of these samples will be stored for later batch assays.

Procedure: Blood Volume Analysis
A small amount of a radioactive isotope or tracer is injected and blood samples are taken at 6 time points during the test and analyzed.

Outcome Measures

Primary Outcome Measures

  1. Assessment of ProEnkephalin to detect acute kidney injury in hospitalized to identify baseline values of PENK biomarkers of AKI in relation to measured intravascular volume. [Hospital admission through hospital discharge, approximately 6 days]

    Blood samples obtained during admission will be assessed for PENK biomarkers. Samples will be stored from all subjects for future analysis if PENK is supportive of a trend based on the PENK data.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Mayo Clinic in RochesterRochesterMinnesotaUnited States55905

Sponsors and Collaborators

  • Mayo Clinic
  • Sphingotec GmbH

Investigators

  • Principal Investigator: Wayne Miller, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Wayne L. Miller, M.D., Ph.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT04019314
Other Study ID Numbers:
  • 18-000181
First Posted:
Jul 15, 2019
Last Update Posted:
Nov 30, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 30, 2021