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

Intervention / Treatment

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

  • United States
    • 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
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

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

Dallas VA Medical Center

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

Keywords

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.

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