NCT02029820

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
210

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2012

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 8, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 8, 2014

Status Verified

January 1, 2014

Enrollment Period

3.3 years

First QC Date

January 6, 2014

Last Update Submit

January 6, 2014

Conditions

Radiographic Contrast Agent Nephropathy

Keywords

Contrast NephropathyPreventionRenalguard

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

RenalGuard

ACTIVE COMPARATOR

Hydration with the device renalguard

Device: RenalGuard

Saline

NO INTERVENTION

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

Interventions

RenalGuardDEVICE

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

RenalGuard

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital São Lucas -PUCRS, Serviço de Hemodinâmica

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

RECRUITING

Study Officials

  • Vitor O Gomes, MD,PhD

    Hospital Sao Lucas

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aryadina Piva, RN

CONTACT

55 51 33203494pesquisa@cardiarte.com.br

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

January 6, 2014

First Posted

January 8, 2014

Study Start

August 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 8, 2014

Record last verified: 2014-01

Locations

BR(1)