Continuous Renal Replacement TherapyNCT01405092
Continuous Versus Conventional Volume Management During CRRT (Continuous Renal Replacement Therapy)
A study testing use of continuous renal replacement machine for renal replacement and use of blood volume monitoring device in conjunction with machine used for continuous renal replacement to assess and determine volume removal in people with Continuous Renal Replacement Therapy, run by Dallas VA Medical Center at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Continuous Renal Replacement Therapy
- What is being tested?
- use of continuous renal replacement machine for renal replacement and use of blood volume monitoring device in conjunction with machine used for continuous renal replacement to assess and determine volume removal
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with kidney injury requiring continuous renal replacement therapy and volume removal
Who cannot join
- unable to provide or obtain patient consent
- not expected to survive 48 hours
Trial locations and contacts
1 site in 1 country.
About this study
Use of on-line blood volume monitoring during continuous renal replacement therapy can improve volume management in acute kidney injury patients requiring renal replacement
- Conditions
- Continuous Renal Replacement Therapy
- Being tested
- use of continuous renal replacement machine for renal replacement, use of blood volume monitoring device in conjunction with machine used for continuous renal replacement to assess and determine volume removal
- Keywords
- volume, acute kidney injury, continuous renal replacement
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
use of continuous renal replacement machine for renal replacementDevice
usual care with volume removal during continuous renal replacement therapy
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
| Study group | Role | What they receive |
|---|---|---|
| Standard volume management | Placebo comparator | patients on this arm will receive usual care volume management during continuous renal replacement therapy Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hour for each arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2011 (estimated)
- Study startApr 2010
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Continuous Renal Replacement TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dallas VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Devasmita C. Dev MD, Dallas VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01405092
- Sponsor's protocol ID
- #09-097
- Status last verified
- Aug 2012
- First submitted
- 28 Jul 2011
- Last updated
- 8 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Versus Conventional Volume Management During CRRT (Continuous Renal Replacement Therapy)
- ClinicalTrials.gov ID
- NCT01405092
- Acronym / sponsor ID
- #09-097
- Conditions
- Continuous Renal Replacement Therapy
- Keywords
- volume, acute kidney injury, continuous renal replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Dallas VA Medical CenterUS federal agency
- Study start
- Apr 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 29 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard volume management | Placebo comparator | Device: use of continuous renal replacement machine for renal replacementpatients on this arm will receive usual care volume management during continuous renal replacement therapy |
| continuous volume management | Active comparator | 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 removaluse of Critline, Hemametrics USA, in conjunction with continuous renal replacment therapy to determine volume removal |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with kidney injury requiring continuous renal replacement therapy and volume removal
Key exclusion criteria (2 listed)
- unable to provide or obtain patient consent
- not expected to survive 48 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| use of continuous renal replacement machine for renal replacementusual care with volume removal during continuous renal replacement therapy | Device | Standard volume management, continuous volume management |
| use of blood volume monitoring device in conjunction with machine used for continuous renal replacement to assess and determine volume removalblood volume monitoring device, Critline, Hemametric, USA, will be used in conjunction with continuous renal replacement to determine rate of volume removal | Device | continuous volume management |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing use of continuous renal replacement machine for renal replacement and use of blood volume monitoring device in conjunction with machine used for continuous renal replacement to assess and determine volume removal in people with Continuous Renal Replacement Therapy, run by Dallas VA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compare number of hypotensive events in treatment versus control arms (time frame: 24 hour for each arm). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2012.