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Proenkephalin A and Kidney Replacement Therapy

NCT ID: NCT04879706

Last Updated: 2023-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-09

Study Completion Date

2023-01-21

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acute Kidney Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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AKI necessitating KRT

Patients with AKI necessitating KRT

None planned

Intervention Type OTHER

No intervention planned

Interventions

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None planned

No intervention planned

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Giessen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Werner Seeger, MD

Role: STUDY_DIRECTOR

University of Giessen

Locations

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University Hospital Gießen and Marburg

Giessen, Hesse, Germany

Site Status

Countries

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Germany

References

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Kim H, Hur M, Struck J, Bergmann A, Di Somma S. Proenkephalin Predicts Organ Failure, Renal Replacement Therapy, and Mortality in Patients With Sepsis. Ann Lab Med. 2020 Nov;40(6):466-473. doi: 10.3343/alm.2020.40.6.466. Epub 2020 Jun 17.

Reference Type BACKGROUND
PMID: 32539302 (View on PubMed)

Other Identifiers

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AZ 37/21

Identifier Type: -

Identifier Source: org_study_id