Proenkephalin A and Kidney Replacement Therapy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| AKI necessitating KRT Patients with AKI necessitating KRT |
Other: None planned
No intervention planned
|
Outcome Measures
Primary Outcome Measures
- Penkid levels at KRT initiation [Up to 2 weeks]
Serial assessment of penkid in patients undergoing KRT
- Penkid levels at discontinuation of KRT [Up to 2 weeks]
Serial assessment of penkid in patients undergoing KRT
Eligibility Criteria
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
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Non-end stage renal disease with extracorporeal ultrafiltration due to diuretic- resistant fluid overload
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Decision to limit therapeutic interventions
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History of solid-organ transplants
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Pregnancy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital Gießen and Marburg | Gießen | Hessen | Germany | 35392 |
Sponsors and Collaborators
- University of Giessen
Investigators
- Study Director: Werner Seeger, MD, University of Giessen
Study Documents (Full-Text)
None provided.More Information
Publications
- AZ 37/21