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Completed

NCT Number: NCT04019314

Assessment of ProEnkephalin to Detect Acute Kidney Injury (AKI)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for 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 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

Treatment and study plan

Blood Collection

Procedure

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

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.

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.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Sphingotec GmbH

Registry information

Official study title

Assessment of ProEnkephalin to Detect Acute Kidney Injury (AKI) in Patients Hospitalized for Volume Overload Decompensated Chronic Heart Failure

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 15, 2019
Registry last updated
Aug 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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