Renal Biomarkers to Predict Recovery Following Venoarteri... | NCT02978378

Studies
Renal Biomarkers to Predict Recovery Following Venoarterial Extracorporeal Membrane Oxygenation

NCT02978378

Sponsor

Milton S. Hershey Medical Center

Status

Terminated

Last Update Posted

Dec 10, 2024Actual

Enrollment

2Actual

Phase

Not provided

Conditions

Acute Kidney Injury

Interventions

biomarker levels

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

insufficient patients to satisfy study protocol(s) inclusion criteria

Expanded Access Info

Start Date

May 1, 2017Actual

Primary Completion Date

Mar 23, 2018Actual

Completion Date

Mar 23, 2018Actual

First Submitted Date

Nov 17, 2016

First Submission Date that Met QC Criteria

Nov 29, 2016

First Posted Date

Nov 30, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 5, 2024

Last Update Posted Date

Dec 10, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Anthony Bonavia, Assistant Professor, Penn State Health Milton S Hershey Medical CenterPrincipal Investigator

Lead Sponsor

Milton S. Hershey Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
biomarker levels	Other	The level of the biomarker hyaluronic acid will be measured

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anthony Bonavia	Milton S. Hershey Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Milton S. Hershey Medical Center		Hershey	Pennsylvania	17033	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D058186	Acute Kidney Injury

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided