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Proenkephalin A and Kidney Replacement Therapy

Proenkephalin A at Initiation and Discontinuation of Kidney Replacement Therapy

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04879706
Enrollment
6
Registered
2021-05-10
Start date
2021-11-09
Completion date
2023-01-21
Last updated
2023-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury

Brief summary

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

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.

Interventions

OTHERNone planned

No intervention planned

Sponsors

University of Giessen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Penkid levels at KRT initiationUp to 2 weeksSerial assessment of penkid in patients undergoing KRT
Penkid levels at discontinuation of KRTUp to 2 weeksSerial assessment of penkid in patients undergoing KRT

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026