Assessment of ProEnkephalin to Detect Acute Kidney Injury (AKI)

NCT04019314 | Completed

• 1 other identifier: 18-000181
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Volume Overload; Decompensated Heart Failure; Systolic Heart Failure

Outcome Measures

Primary Outcomes (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.

  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.

  Hospital admission through hospital discharge, approximately 6 days

Study Arms (1)

Subjects with know chronic systolic heart failure

EXPERIMENTAL

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; Procedure: Blood Volume Analysis

Interventions

Blood Collection PROCEDURE

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

Subjects with know chronic systolic heart failure

Blood Volume Analysis PROCEDURE

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.

Subjects with know chronic systolic heart failure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• Sphingotec GmbH: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Heart Failure; Edema; Heart Failure, Systolic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Wayne Miller, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 25, 2019
• First Posted: July 15, 2019
• Study Start: June 11, 2019
• Primary Completion: October 6, 2021
• Study Completion: October 6, 2021
• Last Updated: August 23, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)