RenalGuard System for Prevention of Contrast Induced Neph... | NCT02029820

Studies
RenalGuard System for Prevention of Contrast Induced Nephropathy

NCT02029820

Sponsor

Hospital Sao Lucas da PUCRS

Status

Unknown status

Last Update Posted

Jan 8, 2014Estimated

Enrollment

210Estimated

Phase

Phase 3

Conditions

Radiographic Contrast Agent Nephropathy

Interventions

RenalGuard

Countries

Brazil

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

Jan 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2012

Primary Completion Date

Dec 2015Estimated

Completion Date

Dec 2015Estimated

First Submitted Date

Jan 6, 2014

First Submission Date that Met QC Criteria

Jan 6, 2014

First Posted Date

Jan 8, 2014Estimated

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

Jan 6, 2014

Last Update Posted Date

Jan 8, 2014Estimated

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine whether hydration with intravenous saline matched with urine output, using the device RenalGuard is superior to standard hydration with saline to prevent contrast-induced nephropathy.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

210Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RenalGuard	Active Comparator	Hydration with the device renalguard	Device: RenalGuard
Saline	No Intervention	Hydration with saline 1ml/Kg/h for 12h

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RenalGuard	Device	Intravenous saline hydration matched with urine output, using the device Renalguard	RenalGuard

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of contrast-induced nephropathy	Contrast-induced nephropathy defined as an increase of serum creatinine of 0.5mg/dl or 25% in pre procedure serum creatinine at 72h after procedure	72 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

serum creatinine >1.2mg/dl
glomerular filtration rate (GFR) < 60ml/min

Exclusion Criteria:

acute renal failure
use of radiological contrast in the latest 7 days
Current use of N-acetylcysteine or hydration of sodium bicarbonate
Patients in dialysis
Emergency procedures

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Aryadina Piva, RN	Contact	55 51 33203494		pesquisa@cardiarte.com.br

Overall Officials

Name	Affiliation	Role
Vitor O Gomes, MD,PhD	Hospital Sao Lucas	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital São Lucas -PUCRS, Serviço de Hemodinâmica	Recruiting	Porto Alegre	Rio Grande do Sul	90610-000	Brazil