NCT01172353

Brief Summary

The purpose of this study is to determine whether hydration with sodium bicarbonate is superior to hydration with saline to prevent contrast-induced nephropathy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
301

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2004

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2004

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 29, 2010

Completed
3.6 years until next milestone

Results Posted

Study results publicly available

February 19, 2014

Completed
Last Updated

February 19, 2014

Status Verified

January 1, 2014

Enrollment Period

3.5 years

First QC Date

July 28, 2010

Results QC Date

January 7, 2014

Last Update Submit

January 7, 2014

Conditions

Renal Failure

Keywords

contras-induced nephropathy

Outcome Measures

Primary Outcomes (1)

  • Contrast-induced Nephropathy

    rise in serum creatinine \>0,5mg/dl

    48 hours

Secondary Outcomes (1)

  • Dialysis During Hospitalization

    During hospitalization

Study Arms (2)

sodium bicarbonate

EXPERIMENTAL

hydration with sodium bicarbonate

Drug: sodium bicarbonate

saline

ACTIVE COMPARATOR

hydration with saline 1ml/Kg/h for 6 hours

Drug: saline

Interventions

sodium bicarbonateDRUG

hydration with sodium bicarbonate 1ml/Kg/h for 6 hours

sodium bicarbonate
salineDRUG

hydration with saline 1ml/Kg/h for 6 hours

saline

Eligibility Criteria

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

You may qualify if:

  • serum creatinine \> 1.1 mg/dL
  • glomerular filtration rate (GFR) \< 50 mL/min

You may not qualify if:

  • age \< 18 years
  • use of radiographic contrast media during the last 21 days
  • history of dialysis
  • cardiac insufficiency class III-IV
  • emergency procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

São Lucas Hospital - PUCRS University

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

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Sodium BicarbonateSodium Chloride

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

BicarbonatesCarbonatesCarbonic AcidCarbon Compounds, InorganicInorganic ChemicalsSodium CompoundsChloridesHydrochloric AcidChlorine Compounds

Results Point of Contact

Title
Vitor Osório Gomes, MD, PhD
Organization
Hospital Sao Lucas
pesquisa@cardiarte.com.br
55 51 33203494

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

July 28, 2010

First Posted

July 29, 2010

Study Start

July 1, 2004

Primary Completion

January 1, 2008

Study Completion

February 1, 2008

Last Updated

February 19, 2014

Results First Posted

February 19, 2014

Record last verified: 2014-01

Locations

BR(1)