Clinical trial NCT04879706: Proenkephalin A and Kidney Replacement Therapy
Official title: Proenkephalin A at Initiation and Discontinuation of Kidney Replacement Therapy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Acute Kidney Injury
Lead sponsor: University of Giessen
Sponsor class: OTHER
First posted: 2021-05-10
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with severe AKI necessitating KRT at the University Hospital Giessen, Giessen, Germany

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.

Eligibility criteria: 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

Primary outcomes:
measure: Penkid levels at KRT initiation
timeFrame: Up to 2 weeks
measure: Penkid levels at discontinuation of KRT
timeFrame: Up to 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gießen
country: Germany
facility: University Hospital Gießen and Marburg
state: Hessen
Study officials:
affiliation: University of Giessen
name: Werner Seeger, MD
role: STUDY_DIRECTOR
References:
citation: 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.