RenalGuard System for Prevention of Contrast Induced Nephropathy

NCT ID: NCT02029820

Last Updated: 2014-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Radiographic Contrast Agent Nephropathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

RenalGuard

Hydration with the device renalguard

Group Type ACTIVE_COMPARATOR

RenalGuard

Intervention Type DEVICE

Intravenous saline hydration matched with urine output, using the device Renalguard

Saline

Hydration with saline 1ml/Kg/h for 12h

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

RenalGuard

Intravenous saline hydration matched with urine output, using the device Renalguard

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospital Sao Lucas da PUCRS

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Vitor Osorio Gomes

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Vitor O Gomes, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Sao Lucas

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital São Lucas -PUCRS, Serviço de Hemodinâmica

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Aryadina Piva, RN

Role: CONTACT

55 51 33203494

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Aryadina Piva, RN

Role: primary

55 51 3320 3494

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

11/05339

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.