Renal Biomarkers to Predict Recovery Following Venoarterial Extracorporeal Membrane Oxygenation

Acute Kidney Injury Clinical Trial

Official title:

Renal Biomarkers to Predict Recovery Following Venoarterial Extracorporeal Membrane Oxygenation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02978378
• Other study ID #: STUDY00006088
• Status: Terminated
• First received: November 17, 2016
• Last updated: March 29, 2018
• Start date: May 1, 2017
• Est. completion date: March 23, 2018

Study information

• Verified date: March 2018
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: March 23, 2018
• Est. primary completion date: March 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

Other:
• biomarker levels
The level of the biomarker hyaluronic acid will be measured

Locations

Country	Name	City	State
United States	Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	renal biomarker levels		through VA-ECMO decannulation, an average of 3 weeks
Primary	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