Proenkephalin A and Kidney Replacement Therapy

November 30, 2023 updated by: University of Giessen

Proenkephalin A at Initiation and Discontinuation of Kidney Replacement Therapy

Acute kidney injury (AKI) is a common problem encountered in the intensive care unit (ICU), estimated to occur in up to 60% of all critically ill patients, depending on the definition. Recent large randomized clinical trials in critical care nephrology have focused on the optimal timing of initiation of acute kidney replacement therapy (KRT). However, less is known about the ideal circumstances in which KRT may be successfully discontinued.

The novel serum-biomarker proenkephalin A 119-159 (penkid) has been found to be strongly negatively correlated with measured GFR. Whether penkid may have a role in initiation and discontinuation of KRT remains unknown.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Acute kidney injury (AKI) is a common problem encountered in the intensive care unit (ICU), estimated to occur in up to 60% of all critically ill patients, depending on the definition. Recent large randomized clinical trials in critical care nephrology have focused on the optimal timing of initiation of acute kidney replacement therapy (KRT). However, less is known about the ideal circumstances in which KRT may be successfully discontinued. KRT is a complex and expensive therapy, with complications including catheter-associated infections, hemorrhage, hemodynamic instability, and potential delayed renal recovery.

The novel serum-biomarker proenkephalin A 119-159 (penkid) is a stable fragment derived from the precursor enkephalins, which are known as small endogenous opioid peptides and are produced throughout the human body, including the kidneys. Plasma concentrations of penkid have been found to be strongly negatively correlated with measured glomerular filtration rate. Whether penkid may have a role in initiation and discontinuation of KRT remains unknown.

Study Type

Observational

Enrollment (Actual)

6

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hessen
      • Gießen, Hessen, Germany, 35392
        • University Hospital Giessen and Marburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Adult patients with severe AKI necessitating KRT at the University Hospital Giessen, Giessen, Germany

Description

Inclusion Criteria:

  • Patients ≥18 years of age with AKI requiring KRT

Exclusion Criteria:

  • Chronic kidney disease with estimated glomerular filtration rate <30 mL/min/1.73 m2
  • Non-end stage renal disease with extracorporeal ultrafiltration due to diuretic- resistant fluid overload
  • Decision to limit therapeutic interventions
  • History of solid-organ transplants
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AKI necessitating KRT
Patients with AKI necessitating KRT
Other: None planned
No intervention planned

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Penkid levels at KRT initiation
Time Frame: Up to 2 weeks
Serial assessment of penkid in patients undergoing KRT
Up to 2 weeks
Penkid levels at discontinuation of KRT
Time Frame: Up to 2 weeks
Serial assessment of penkid in patients undergoing KRT
Up to 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Giessen

Investigators

  • Study Director: Werner Seeger, MD, University of Giessen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 2021

Primary Completion (Actual)

January 21, 2023

Study Completion (Actual)

January 21, 2023

Study Registration Dates

First Submitted

May 3, 2021

First Submitted That Met QC Criteria

May 4, 2021

First Posted (Actual)

May 10, 2021

Study Record Updates

Last Update Posted (Estimated)

December 1, 2023

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AZ 37/21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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