Continuous Versus Conventional Volume Management During CRRT (Continuous Renal Replacement Therapy)
August 7, 2012 updated by: Devasmita C. Dev MD, Dallas VA Medical Center
Use of on-line blood volume monitoring during continuous renal replacement therapy can improve volume management in acute kidney injury patients requiring renal replacement
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75216
- Dallas VA Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Standard volume management
patients on this arm will receive usual care volume management during continuous renal replacement therapy
|
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
|
usual care with volume removal during continuous renal replacement therapy
blood volume monitoring device, Critline, Hemametric, USA, will be used in conjunction with continuous renal replacement to determine rate of volume removal
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
24 hour for each arm
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2010
Primary Completion (Actual)
August 1, 2012
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
July 28, 2011
First Submitted That Met QC Criteria
July 28, 2011
First Posted (Estimate)
July 29, 2011
Study Record Updates
Last Update Posted (Estimate)
August 8, 2012
Last Update Submitted That Met QC Criteria
August 7, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- #09-097
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.