NCT01405092

Brief Summary

Use of on-line blood volume monitoring during continuous renal replacement therapy can improve volume management in acute kidney injury patients requiring renal replacement

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2010

Typical duration for not_applicable

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

April 1, 2010

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 29, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

August 8, 2012

Status Verified

August 1, 2012

Enrollment Period

2.3 years

First QC Date

July 28, 2011

Last Update Submit

August 7, 2012

Conditions

Continuous Renal Replacement Therapy

Keywords

volumeacute kidney injurycontinuous renal replacement

Outcome Measures

Primary Outcomes (1)

  • compare number of hypotensive events in treatment versus control arms

    compare the number of hypotensive events during use of crit-line monitor over 24 hour period versus during control 24 hour period

    24 hour for each arm

Study Arms (2)

Standard volume management

PLACEBO COMPARATOR

patients on this arm will receive usual care volume management during continuous renal replacement therapy

Device: use of continuous renal replacement machine for renal replacement

continuous volume management

ACTIVE COMPARATOR

use of Critline, Hemametrics USA, in conjunction with continuous renal replacment therapy to determine volume removal

Device: use of continuous renal replacement machine for renal replacementDevice: use of blood volume monitoring device in conjunction with machine used for continuous renal replacement to assess and determine volume removal

Interventions

use of continuous renal replacement machine for renal replacementDEVICE

usual care with volume removal during continuous renal replacement therapy

Standard volume managementcontinuous volume management
use of blood volume monitoring device in conjunction with machine used for continuous renal replacement to assess and determine volume removalDEVICE

blood volume monitoring device, Critline, Hemametric, USA, will be used in conjunction with continuous renal replacement to determine rate of volume removal

continuous volume management

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with kidney injury requiring continuous renal replacement therapy and volume removal

You may not qualify if:

  • unable to provide or obtain patient consent
  • not expected to survive 48 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dallas VA Medical Center

Dallas, Texas, 75216, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of In-center and Home Dialysis

Study Record Dates

First Submitted

July 28, 2011

First Posted

July 29, 2011

Study Start

April 1, 2010

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

August 8, 2012

Record last verified: 2012-08

Locations

US(1)