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Continuous Versus Conventional Volume Management During CRRT (Continuous Renal Replacement Therapy)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01405092
Recruitment Status : Completed
First Posted : July 29, 2011
Last Update Posted : August 8, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Condition or disease Intervention/treatment
Continuous Renal Replacement Therapy Device: use of continuous renal replacement machine for renal replacement Device: use of blood volume monitoring device in conjunction with machine used for continuous renal replacement to assess and determine volume removal

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Study Start Date : April 2010
Primary Completion Date : August 2012
Study Completion Date : August 2012
Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Standard volume management
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
usual care with volume removal during continuous renal replacement therapy
Active Comparator: continuous volume management
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 replacement
usual care with volume removal during continuous renal replacement therapy
Device: use of blood volume monitoring device in conjunction with machine used for continuous renal replacement to assess and determine volume removal
blood volume monitoring device, Critline, Hemametric, USA, will be used in conjunction with continuous renal replacement to determine rate of volume removal


Outcome Measures

Primary Outcome Measures :
  1. compare number of hypotensive events in treatment versus control arms [ Time Frame: 24 hour for each arm ]
    compare the number of hypotensive events during use of crit-line monitor over 24 hour period versus during control 24 hour period


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01405092


Locations
United States, Texas
Dallas VA Medical Center
Dallas, Texas, United States, 75216
Sponsors and Collaborators
Dallas VA Medical Center
More Information

Responsible Party: Devasmita C. Dev MD, Director of In-center and Home Dialysis, Dallas VA Medical Center
ClinicalTrials.gov Identifier: NCT01405092     History of Changes
Other Study ID Numbers: #09-097
First Posted: July 29, 2011    Key Record Dates
Last Update Posted: August 8, 2012
Last Verified: August 2012

Keywords provided by Devasmita C. Dev MD, Dallas VA Medical Center:
volume
acute kidney injury
continuous renal replacement