Proenkephalin A and Kidney Replacement Therapy

Acute Kidney Injury Clinical Trial

Official title:

Proenkephalin A at Initiation and Discontinuation of Kidney Replacement Therapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04879706
• Other study ID #: AZ 37/21
• Status: Terminated
• Start date: November 9, 2021
• Est. completion date: January 21, 2023

Study information

• Verified date: November 2023
• Source: University of Giessen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: January 21, 2023
• Est. primary completion date: January 21, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

Other:
• None planned
No intervention planned

Locations

Country	Name	City	State
Germany	University Hospital Gießen and Marburg	Gießen	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
University of Giessen

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Penkid levels at KRT initiation	Serial assessment of penkid in patients undergoing KRT	Up to 2 weeks
Primary	Penkid levels at discontinuation of KRT	Serial assessment of penkid in patients undergoing KRT	Up to 2 weeks