search
Back to results

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

Primary Purpose

Contrast Induced Acute Kidney Injury

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
bicarbonates
saline
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Contrast Induced Acute Kidney Injury focused on measuring intensive care unit

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical Intensive Care Unit
  • Surgical Intensive Care Unit
  • Intensive care unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

bicarbonates

saline

Arm Description

sodium bicarbonates 1,4%

sodium chloride 0,9%

Outcomes

Primary Outcome Measures

contrast induced acute kidney injury

Secondary Outcome Measures

Full Information

First Posted
February 15, 2012
Last Updated
February 2, 2015
Sponsor
University Hospital, Caen
search

1. Study Identification

Unique Protocol Identification Number
NCT01636089
Brief Title
Bicarbonates Versus Saline for Contrast Induced Acute Kidney Injury Prevention in Intensive Care Unit
Acronym
HYDRAREA
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contrast Induced Acute Kidney Injury
Keywords
intensive care unit

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
bicarbonates
Arm Type
Experimental
Arm Description
sodium bicarbonates 1,4%
Arm Title
saline
Arm Type
Active Comparator
Arm Description
sodium chloride 0,9%
Intervention Type
Drug
Intervention Name(s)
bicarbonates
Intervention Description
sodium bicarbonates 1,4%
Intervention Type
Drug
Intervention Name(s)
saline
Intervention Description
sodium chloride 0,9%
Primary Outcome Measure Information:
Title
contrast induced acute kidney injury
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Medical Intensive Care Unit
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Surgical Intensive Care Unit
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Intensive care unit
City
Saint Lô
ZIP/Postal Code
50000
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs