Proenkephalin A and Kidney Replacement Therapy
- Conditions
- Acute Kidney Injury
- Interventions
- Other: None planned
- Registration Number
- NCT04879706
- Lead Sponsor
- University of Giessen
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 6
- Patients ≥18 years of age with AKI requiring KRT
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description AKI necessitating KRT None planned Patients with AKI necessitating KRT
- Primary Outcome Measures
Name Time Method Penkid levels at discontinuation of KRT Up to 2 weeks Serial assessment of penkid in patients undergoing KRT
Penkid levels at KRT initiation Up to 2 weeks Serial assessment of penkid in patients undergoing KRT
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Hospital Gießen and Marburg
🇩🇪Gießen, Hessen, Germany