NCT00811109

Brief Summary

The purpose of this randomized controlled study is to compare the effects of different new dialysis on-line monitoring devices on hemodynamic stability during intermittent hemodialysis in critically ill patients with acute kidney injury.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2008

Shorter than P25 for phase_2

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 18, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

March 3, 2010

Status Verified

March 1, 2010

Enrollment Period

1.1 years

First QC Date

December 15, 2008

Last Update Submit

March 2, 2010

Conditions

Hemodialysis

Keywords

Acute Kidney InjuryCritical careHypotensionRenal replacement therapyEfficacyToleranceOutcome

Outcome Measures

Primary Outcomes (1)

  • Intra-Dialytic Hypotension

    60 days

Secondary Outcomes (1)

  • Compliance to treatment; intra-dialytic complications; dialysis dose; blood temperature control; blood volume control

    60 days

Study Arms (3)

Standard

NO INTERVENTION

Gold standard bicarbonate hemodialysis therapy with constant ultrafiltration rate and dialysis conductivity

Device: Standard Hemodialysis

2

ACTIVE COMPARATOR

With Blood Volume on-line monitoring only

Device: with Blood Volume Management (BVM®) only

3

ACTIVE COMPARATOR

With Blood volume and Blood temperature on-line monitoring

Device: with Blood Volume (BVM®) and Temperature (BTM®) on-line monitoring

Interventions

Standard HemodialysisDEVICE

Gold standard bicarbonate hemodialysis therapy with constant ultrafiltration rate and dialysis conductivity performed with Fresenius 4008S monitor (Fresenius Medical Care, France)

Also known as: Treatment A
Standard
with Blood Volume Management (BVM®) onlyDEVICE

Hemodialysis using Blood Volume on-line monitoring only. Hemodialysis will be performed with Fresenius 4008S monitor (Fresenius Medical Care, France) equipped with BVM® device (for blood volume monitor; Fresenius Medical Care, France)

Also known as: Treatment B
2
with Blood Volume (BVM®) and Temperature (BTM®) on-line monitoringDEVICE

Hemodialysis using Blood volume and Blood temperature on-line monitoring. Hemodialysis will be performed with Fresenius 4008S monitor (Fresenius Medical Care, France) equipped with BVM® and BTM® devices (for blood volume monitor and blood temperature management, respectively; Fresenius Medical Care, France)

Also known as: Treatment C
3

Eligibility Criteria

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

You may qualify if:

  • Age \> 18 years
  • Acute Kidney injury requiring intermittent hemodialysis

You may not qualify if:

  • Age \< 18 years
  • End-stage renal failure
  • Absence of consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Réanimation Médicale - CHU de Caen

Caen, 14000, France

Location

Related Publications (2)

  • Marshall MR, Wang MY, Vandal AC, Dunlop JL. Low dialysate sodium levels for chronic haemodialysis. Cochrane Database Syst Rev. 2024 Nov 5;11(11):CD011204. doi: 10.1002/14651858.CD011204.pub3.

    PMID: 39498822DERIVED

  • du Cheyron D, Terzi N, Seguin A, Valette X, Prevost F, Ramakers M, Daubin C, Charbonneau P, Parienti JJ. Use of online blood volume and blood temperature monitoring during haemodialysis in critically ill patients with acute kidney injury: a single-centre randomized controlled trial. Nephrol Dial Transplant. 2013 Feb;28(2):430-7. doi: 10.1093/ndt/gfs124. Epub 2012 Apr 25.

    PMID: 22535635DERIVED

MeSH Terms

Conditions

Acute Kidney InjuryHypotension

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Damien du CHEYRON, MD, PhD

    University Hospital, Caen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 15, 2008

First Posted

December 18, 2008

Study Start

December 1, 2008

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

March 3, 2010

Record last verified: 2010-03

Locations

FR(1)