Sodium Bicarbonate for Prevention of Contrast-Induced Nephropathy

NCT ID: NCT01172353

Last Updated: 2014-02-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

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

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

301 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2008-02-29

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 sodium bicarbonate is superior to 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.

Renal Failure

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

SINGLE

Outcome Assessors

Study Groups

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

sodium bicarbonate

hydration with sodium bicarbonate

Group Type EXPERIMENTAL

sodium bicarbonate

Intervention Type DRUG

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

saline

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

Group Type ACTIVE_COMPARATOR

saline

Intervention Type DRUG

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

Interventions

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

sodium bicarbonate

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

Intervention Type DRUG

saline

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

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

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

Exclusion Criteria

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

Locations

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

São Lucas Hospital - PUCRS University

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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

Brazil

Other Identifiers

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

HSaoLucas

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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