Renal Biomarkers to Predict Recovery Following Venoarterial Extracorporeal Membrane Oxygenation

NCT02978378 | Terminated

• 1 other identifier: STUDY00006088
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

biomarker levels OTHER

The level of the biomarker hyaluronic acid will be measured

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

urine and 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

• Anthony Bonavia

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 17, 2016
• First Posted: November 30, 2016
• Study Start: May 1, 2017
• Primary Completion: March 23, 2018
• Study Completion: March 23, 2018
• Last Updated: December 10, 2024

Record last verified: 2018-03

Locations

US (1)