Renal Biomarkers to Predict Recovery Following Venoarterial Extracorporeal Membrane Oxygenation

The investigators objective is to assess the utility of renal biomarkers in predicting renal recovery following institution of Venoarterial Extracorporeal Membrane Oxygenation (VA-ECMO). Tissue biomarkers of renal injury may provide a real-time indication of renal function and the likelihood of renal recovery in patients having cardiogenic shock and requiring VA-ECMO. In these patients, traditional markers of kidney function (urine output and serum Creatinine level) do not accurately represent renal function.

Study Overview

• Status: Terminated
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Other: biomarker levels

• Study Type: Observational
• Enrollment (Actual): 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Milton S. Hershey Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients with cardiogenic shock and acute kidney injury requiring continuous renal replacement therapy

Description

Inclusion Criteria:

• age more than 18 years
• refractory or advanced cardiogenic shock prior to institution of VA-ECMO

Exclusion Criteria:

• History of chronic kidney disease prior to cardiogenic shock, as defined by estimated glomerular filtration rate (GFR) less than 60 mL per min
• Cognitive impairment
• Pregnant women
• patient or surrogate is not fluent in English
• Long-term immunosuppression

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
renal biomarker levels		through VA-ECMO decannulation, an average of 3 weeks
need for continuous renal replacement therapy at hospital discharge (Yes/No)	The need for continuous renal replacement therapy at hospital discharge will be assessed using hospital medical records	measured at hospital discharge, an average of 2-3 months following initial hospital admission

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Investigators: Principal Investigator: Anthony Bonavia, Milton S. Hershey Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): March 23, 2018
• Study Completion (Actual): March 23, 2018

Study Registration Dates

• First Submitted: November 17, 2016
• First Submitted That Met QC Criteria: November 29, 2016
• First Posted (Estimated): November 30, 2016

Study Record Updates

• Last Update Posted (Actual): December 10, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: STUDY00006088

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No