Bicarbonates Versus Saline for Contrast Induced Acute Kidney Injury Prevention in Intensive Care Unit

NCT ID: NCT01636089

Last Updated: 2015-02-03

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2015-01-31

Brief Summary

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

The aim of this study is to compare bicarbonates versus saline for prevention of contrast induced acute kidney injury in critically ill patients.

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.

Contrast Induced Acute Kidney Injury

Study Design

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

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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

bicarbonates

sodium bicarbonates 1,4%

Group Type EXPERIMENTAL

bicarbonates

Intervention Type DRUG

sodium bicarbonates 1,4%

saline

sodium chloride 0,9%

Group Type ACTIVE_COMPARATOR

saline

Intervention Type DRUG

sodium chloride 0,9%

Interventions

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

bicarbonates

sodium bicarbonates 1,4%

Intervention Type DRUG

saline

sodium chloride 0,9%

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

* patient \> 18 years old
* in intensive care unit since 24h and for up to 48 hours
* with contrast medium injection

Exclusion Criteria

* patient under renal replacement therapy
* rise in creatinine \> 26µmol/L within 48hours
* anuria within 12 hours
* cardiogenic pulmonary oedema
* pH \> 7.50 or kaliemia \< 3mmol/L
* pregnancy
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.

University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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

Responsibility Role SPONSOR

Locations

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

Medical Intensive Care Unit

Caen, , France

Site Status

Surgical Intensive Care Unit

Caen, , France

Site Status

Intensive care unit

Saint-Lô, , France

Site Status

Countries

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

France

Other Identifiers

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

2011-A00227-34

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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

TIMP2*IGFBP7 and Transient AKI
NCT03472079 RECRUITING
RenalGuard System and Contrast Media
NCT01098032 COMPLETED PHASE3