NCT01636089

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2012

Typical duration for phase_3

Geographic Reach
1 country

3 active sites

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

February 1, 2012

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2012

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 10, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

February 17, 2026

Status Verified

February 1, 2015

Enrollment Period

2.9 years

First QC Date

February 15, 2012

Last Update Submit

February 13, 2026

Conditions

Contrast Induced Acute Kidney Injury

Keywords

intensive care unit

Outcome Measures

Primary Outcomes (1)

  • contrast induced acute kidney injury

    72 hours

Study Arms (2)

bicarbonates

EXPERIMENTAL

sodium bicarbonates 1,4%

Drug: bicarbonates

saline

ACTIVE COMPARATOR

sodium chloride 0,9%

Drug: saline

Interventions

bicarbonatesDRUG

sodium bicarbonates 1,4%

bicarbonates
salineDRUG

sodium chloride 0,9%

saline

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Medical Intensive Care Unit

Caen, 14033, France

Location

Surgical Intensive Care Unit

Caen, 14033, France

Location

Intensive care unit

Saint-Lô, 50000, France

Location

Related Publications (1)

  • Timal RJ, Kooiman J, Sijpkens YWJ, de Vries JPM, Verberk-Jonkers IJAM, Brulez HFH, van Buren M, van der Molen AJ, Cannegieter SC, Putter H, van den Hout WB, Jukema JW, Rabelink TJ, Huisman MV. Effect of No Prehydration vs Sodium Bicarbonate Prehydration Prior to Contrast-Enhanced Computed Tomography in the Prevention of Postcontrast Acute Kidney Injury in Adults With Chronic Kidney Disease: The Kompas Randomized Clinical Trial. JAMA Intern Med. 2020 Apr 1;180(4):533-541. doi: 10.1001/jamainternmed.2019.7428.

    PMID: 32065601RESULT

MeSH Terms

Interventions

BicarbonatesSodium Chloride

Intervention Hierarchy (Ancestors)

CarbonatesCarbonic AcidCarbon Compounds, InorganicInorganic ChemicalsAnionsIonsElectrolytesChloridesHydrochloric AcidChlorine CompoundsSodium Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2012

First Posted

July 10, 2012

Study Start

February 1, 2012

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

February 17, 2026

Record last verified: 2015-02

Locations

FR(3)