Acute Kidney InjuryNCT03078504
Hemodynamic Effects of Blood Flow Variation in Continuous Renal Replacement Therapy
A study testing continuous renal replacement therapy using System One (TM) setup (Nxstage) in people with Acute Kidney Injury and End-stage Renal Disease, run by St. Louis University at 1 site in United States.
Trial summary
Purpose of this study is to evaluate the short-term hemodynamic effects of changes in blood flow rates in critically ill patients receiving continuous renal replacement therapy. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Acute Kidney Injury, End-stage Renal Disease
- What is being tested?
- continuous renal replacement therapy using System One (TM) setup (Nxstage)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2017to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-89
- Acute renal failure or end-stage renal disease necessitating CRRT
- Admitted to the MICU service
- If on vasopressor/inotropic agent, norepinephrine as only intravenous pressor
- If on vasopressor/inotropic agent, at stable pressor dose for at least four hours
- If on IV fluids, stable dose of crystalloids <= 100cc/hour and is not receiving colloids for 4 hours or more prior to initiation of CRRT
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- Mean arterial pressure (MAP) >= 65
- Arterial catheter present for continuous blood pressure monitoring
- CRRT duration of 48 hours or less using NxStage System One dialysis system
- successfully tolerated CRRT for at least 4 hours without clotting or hemodynamic instability
- no other procedures, blood products transfusion, or additional medication administration are anticipated during the study period
Who cannot join
- listed for organ transplant
- atrial fibrillation, other irregular heart rhythm, unstable arrhythmia
- need for more than one intravenous vasopressor agent
- intravenous vasopressor/inotropic agent other than norepinephrine (ie dobutamine, dopamine, vasopressin, epinephrine)
- therapeutic anticoagulation being administered
- known acute myocardial infarction as defined by elevated troponin along with a documented clinical diagnosis during current hospitalization
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- known acute stroke, intracerebral hemorrhage, intracranial mass effect, or elevated intracranial pressure within the last 30 days.
- dialysis catheter malfunction and unable to maintain target blood flow rate
- fluid removal (ultrafiltration) rate > 100mL/hour
Trial locations and contacts
1 site in 1 country.
About this study
Purpose of this study is to evaluate the short-term hemodynamic effects of changes in blood flow rates in critically ill patients receiving continuous renal replacement therapy.
- Conditions
- Acute Kidney Injury, End-stage Renal Disease
- Being tested
- continuous renal replacement therapy using System One (TM) setup (Nxstage)
- Medical subject headings
- Acute Kidney Injury, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous renal replacement therapy using System One (TM) setup (Nxstage)Device
Also called NxStage
Participants who have been prescribed continuous renal replacement therapy will have hemodynamic parameters measured at various blood flow rates
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | The patients will have the blood flow rate adjusted on CRRT gradually increased to assess the effect on hemodynamics Receives: Device: continuous renal replacement therapy using System One (TM) setup (Nxstage) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure Change
Change in mean arterial pressure from period 1 to period 2
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2017
- Study start17 Feb 2017
- Primary completion6 Jun 2018
- Study completion30 Jun 2018
Why it stopped: Failure to recruit patients further
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Kidney InjuryStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zafar Jamkhana, MD, St. Louis University
- Investigators
- Zafar Jamkhana, MD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03078504
- Sponsor's protocol ID
- 26817
- Status last verified
- Mar 2020
- First submitted
- 8 Mar 2017
- Last updated
- 30 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Effects of Blood Flow Variation in Continuous Renal Replacement Therapy
- ClinicalTrials.gov ID
- NCT03078504
- Acronym / sponsor ID
- 26817
- Conditions
- Acute Kidney Injury, End-stage Renal Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Failure to recruit patients further
- Enrolment
- 6 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Study start
- 17 Feb 2017 (actual)
- Primary completion
- 6 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 13 Mar 2017 (actual)
- Results
- Posted 30 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose of this study is to evaluate the short-term hemodynamic effects of changes in blood flow rates in critically ill patients receiving continuous renal replacement therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Device: continuous renal replacement therapy using System One (TM) setup (Nxstage)The patients will have the blood flow rate adjusted on CRRT gradually increased to assess the effect on hemodynamics |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18-89
- Acute renal failure or end-stage renal disease necessitating CRRT
- Admitted to the MICU service
- If on vasopressor/inotropic agent, norepinephrine as only intravenous pressor
- If on vasopressor/inotropic agent, at stable pressor dose for at least four hours
Key exclusion criteria (9 listed)
- listed for organ transplant
- atrial fibrillation, other irregular heart rhythm, unstable arrhythmia
- need for more than one intravenous vasopressor agent
- intravenous vasopressor/inotropic agent other than norepinephrine (ie dobutamine, dopamine, vasopressin, epinephrine)
- therapeutic anticoagulation being administered
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 |
|---|---|---|
| continuous renal replacement therapy using System One (TM) setup (Nxstage)Also: NxStageParticipants who have been prescribed continuous renal replacement therapy will have hemodynamic parameters measured at various blood flow rates | Device | Experimental arm |
Primary outcome
Blood Pressure Change
Time frame: 10 minutes
Change in mean arterial pressure from period 1 to period 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Zafar Jamkhana, MD principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing continuous renal replacement therapy using System One (TM) setup (Nxstage) in people with Acute Kidney Injury and End-stage Renal Disease, run by St. Louis University 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 11 inclusion and 9 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: stopped early, as of the sponsor's last update on 30 Mar 2020. 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. 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?
Yes. Results are posted in the registry (first posted 30 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Blood Pressure Change (time frame: 10 minutes). 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 30 Mar 2020.