Proenkephalin A and Kidney Replacement Therapy

NCT04879706 | Terminated DMC

• 1 other identifier: AZ 37/21
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (2)

• Penkid levels at KRT initiation

  Serial assessment of penkid in patients undergoing KRT

  Up to 2 weeks

• Penkid levels at discontinuation of KRT

  Serial assessment of penkid in patients undergoing KRT

  Up to 2 weeks

Study Arms (1)

AKI necessitating KRT

Patients with AKI necessitating KRT

Other: None planned

Interventions

None planned OTHER

No intervention planned

AKI necessitating KRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with severe AKI necessitating KRT at the University Hospital Giessen, Giessen, Germany

You may qualify if:

• Patients ≥18 years of age with AKI requiring KRT

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Giessen: lead

Study Sites (1)

University Hospital Gießen and Marburg

Giessen, Hesse, 35392, Germany

Location

Related 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.

  PMID: 32539302 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Werner Seeger, MD

  University of Giessen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 10, 2021
• Study Start: November 9, 2021
• Primary Completion: January 21, 2023
• Study Completion: January 21, 2023
• Last Updated: December 1, 2023

Record last verified: 2023-11

Locations

DE (1)