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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Devasmita C. Dev MD, Dallas VA Medical Center
ClinicalTrials.gov Identifier:
NCT01405092
First received: July 28, 2011
Last updated: August 7, 2012
Last verified: August 2012
  Purpose

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 Intervention
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 Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care

Further study details as provided by Dallas VA Medical Center:

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


Enrollment: 28
Study Start Date: April 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01405092

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

No publications provided

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
Study First Received: July 28, 2011
Last Updated: August 7, 2012
Health Authority: United States: Federal Government

Keywords provided by Dallas VA Medical Center:
volume
acute kidney injury
continuous renal replacement

ClinicalTrials.gov processed this record on November 20, 2014