LeukemiaNCT01755000
Study of Hypotensive Hematopoietic Malignancy Patients' USCOM Readings
A study testing USCOM scan and Fluid Bolus in people with Leukemia and Lymphoma, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to test how practical it is to use the Ultrasonic Cardiac Output Monitor (USCOM), an FDA-approved device, on oncology patients (specifically those with blood cancers). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Lymphoma, Paraproteinemias
- What is being tested?
- USCOM scan and Fluid Bolus
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Apr 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -≥ 18 years of age
- English speaker
- Diagnosis of blood dyscrasia, hematopoietic malignancy, or condition that may requires HSCT
Who cannot join
- Obstruction of the suprasternal notch that prevents placing the USCOM probe in the correct location
- Tracheostomy or endotracheal tube that prevents placing USCOM probe in the correct location
- Inability to lie flat, on left or right side, or with the head of bed at a 30 degree angle for the USCOM exam (ex. due to respiratory distress or physiologic reasons)
- Impairment by a psychiatric, cognitive, or physiologic disorder that limits ability to understand explanation of study and give consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Pilot Feasibility Study of Hypotensive Hematopoietic Malignancy Patients' USCOM Readings
The purpose of this study is to test how practical it is to use the Ultrasonic Cardiac Output Monitor (USCOM), an FDA-approved device, on oncology patients (specifically those with blood cancers). Additionally, the researchers will learn if the USCOM gives additional information about patients' conditions when their blood pressures drop and they are treated with intravenous fluids.
- Being tested
- USCOM scan, Fluid Bolus
- Medical subject headings
- Leukemia, Lymphoma, Paraproteinemias, Multiple Myeloma, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
USCOM scanProcedure or surgery
Fluid BolusProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Aim 1: Hemodynamically Healthy Patients | Other | Nurse 1 will perform an USCOM scan and record values of Vpk and SV on the clinical data sheet.
Nurse 2 will perform the USCOM second scan within five minutes of Nurse 1's scan and record the values of Vpk and SV on the clinical data sheet.
Nurse 1 and 2 will be blinded to each other's scans by using separate clinical data forms Receives: Procedure: USCOM scan |
| Aim 2: Hemodynamically Unstable Patients | Other | Nurse 1 will perform an USCOM scan and record values of Vpk and SV on the clinical data sheet.
Nurse 2 will also be notified of the hypotensive event, will then perform the USCOM second scan within five minutes of PI's scan and record the values of Vpk and SV on the clinical data sheet.
The two USCOM scans will be completed within 10 minutes of the hypotensive episode.
Nurse 1 and Nurse 2 will be blinded to each other's scans by using separate clinical data forms. Receives: Procedure: USCOM scan |
| Aim 3: Hemodynamically Unstable Patients + Fluid Bolus | Other | At the time that an enrolled patient meets one of the following criteria; SBP drops below 95 mmHg or MAP drops below 65 mmHg the PI will be notified to PI to perform the USCOM scan and record the Vpk, SV, systolic blood pressure and mean arterial pressure on the clinical data sheet within 10 minutes of the hypotensive episode, prior to the patient receiving a fluid bolus (fluid bolus is part of standard of care).
The USCOM scan will then be repeated within 5 minutes after fluid bolus delivery.
Before the hemodynamically unstable patient receives subsequent fluid boluses (multiple boluses are common standard of care), the PI will perform an USCOM scan. Then within 5 minutes after the delivered fluid bolus, the PI will perform another USCOM scan. This will continue, until no further boluses are prescribed. Receives: Procedure: USCOM scan; Procedure: Fluid Bolus |
What is being measured
The primary outcome is the main question the study is designed to answer.
What is the inter-rater agreement between multiple independent USCOM users measuring stroke volume (SV) and peak velocity (Vpk) whose systolic blood pressures (SBPs) and mean arterial pressures (MAPs) are stable (SBP above 95 mmHg and MAP above 65 mmHg)?
Pairs of USCOM measurements from multiple raters for SV and Vpk, both of which are interval-level measures. Inter-rater reliability will be assessed using the Intraclass Correlation Coefficient (ICC); our design fits into case 1 using the Shrout and Fleiss (1979) classification system.
Measured: 1 day (one time event for patient)
What is the inter-rater agreement between multiple independent USCOM users measuring SV and Vpk in hematopoietic malignancy patients whose SBPs drop below 95mmHg or MAPs drop below 65mmHg?
pairs of USCOM measurements from multiple raters for SV and Vpk. We will use the ICC to evaluate rater agreement here, as well, with the same sample size and the same confidence interval. For Aim 2, though, if the second rating cannot be completed within 5 minutes of the first, that episode will be excluded from the study.
Measured: 1 day (one time event for patient)
In what percentage of patients is fluid bolus administration successful as measured by the current standard of care (MAP) and what is the level of agreement between the standard measure and USCOM readings in determining return to hemodynamic stability?
After two raters have measured SV and Vpk, bolus will be administered. Determining the success of bolus administration, we will simply record whether the clinician judged the bolus to be successful. In addition, one rater will measure SV and Vpk again using USCOM within 5 minutes of bolus administration. We will then calculate the percentage of patients whose stroke volume and peak velocity increased at least 15% after bolus administration using the post-bolus USCOM reading and the same rater's pre-bolus USCOM reading. We chose an increase of 15% based on a review of the research as the threshold that would best indicate a therapeutic response to bolus administration.
Measured: 1 day (one time event for patient)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michelle Parmentier, RN, BSN, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01755000
- Sponsor's protocol ID
- 201206070
- Status last verified
- Aug 2013
- First submitted
- 18 Dec 2012
- Last updated
- 2 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Feasibility Study of Hypotensive Hematopoietic Malignancy Patients' USCOM Readings
- ClinicalTrials.gov ID
- NCT01755000
- Acronym / sponsor ID
- 201206070
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 21 Dec 2012 (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.
The purpose of this study is to test how practical it is to use the Ultrasonic Cardiac Output Monitor (USCOM), an FDA-approved device, on oncology patients (specifically those with blood cancers). Additionally, the researchers will learn if the USCOM gives additional information about patients' conditions when their blood pressures drop and they are treated with intravenous fluids.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aim 1: Hemodynamically Healthy Patients | Other | Procedure: USCOM scanNurse 1 will perform an USCOM scan and record values of Vpk and SV on the clinical data sheet. Nurse 2 will perform the USCOM second scan within five minutes of Nurse 1's scan and record the values of Vpk and SV on the clinical data sheet. Nurse 1 and 2 will be blinded to each other's scans by using separate clinical data forms |
| Aim 2: Hemodynamically Unstable Patients | Other | Procedure: USCOM scanNurse 1 will perform an USCOM scan and record values of Vpk and SV on the clinical data sheet. Nurse 2 will also be notified of the hypotensive event, will then perform the USCOM second scan within five minutes of PI's scan and record the values of Vpk and SV on the clinical data sheet. The two USCOM scans will be completed within 10 minutes of the hypotensive episode. Nurse 1 and Nurse 2 will be blinded to each other's scans by using separate clinical data forms. |
| Aim 3: Hemodynamically Unstable Patients + Fluid Bolus | Other | Procedure: USCOM scan, Procedure: Fluid BolusAt the time that an enrolled patient meets one of the following criteria; SBP drops below 95 mmHg or MAP drops below 65 mmHg the PI will be notified to PI to perform the USCOM scan and record the Vpk, SV, systolic blood pressure and mean arterial pressure on the clinical data sheet within 10 minutes of the hypotensive episode, prior to the patient receiving a fluid bolus (fluid bolus is part of standard of care). The USCOM scan will then be repeated within 5 minutes after fluid bolus delivery. Before the hemodynamically unstable patient receives subsequent fluid boluses (multiple boluses are common standard of care), the PI will perform an USCOM scan. Then within 5 minutes after the delivered fluid bolus, the PI will perform another USCOM scan. This will continue, until no further boluses are prescribed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- -≥ 18 years of age
- English speaker
- Diagnosis of blood dyscrasia, hematopoietic malignancy, or condition that may requires HSCT
Key exclusion criteria (4 listed)
- Obstruction of the suprasternal notch that prevents placing the USCOM probe in the correct location
- Tracheostomy or endotracheal tube that prevents placing USCOM probe in the correct location
- Inability to lie flat, on left or right side, or with the head of bed at a 30 degree angle for the USCOM exam (ex. due to respiratory distress or physiologic reasons)
- Impairment by a psychiatric, cognitive, or physiologic disorder that limits ability to understand explanation of study and give consent
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 |
|---|---|---|
| USCOM scan | Procedure or surgery | Aim 1: Hemodynamically Healthy Patients, Aim 2: Hemodynamically Unstable Patients, Aim 3: Hemodynamically Unstable Patients + Fluid Bolus |
| Fluid Bolus | Procedure or surgery | Aim 3: Hemodynamically Unstable Patients + Fluid Bolus |
Primary outcome
What is the inter-rater agreement between multiple independent USCOM users measuring stroke volume (SV) and peak velocity (Vpk) whose systolic blood pressures (SBPs) and mean arterial pressures (MAPs) are stable (SBP above 95 mmHg and MAP above 65 mmHg)?
Time frame: 1 day (one time event for patient)
Pairs of USCOM measurements from multiple raters for SV and Vpk, both of which are interval-level measures. Inter-rater reliability will be assessed using the Intraclass Correlation Coefficient (ICC); our design fits into case 1 using the Shrout and Fleiss (1979) classification system.
What is the inter-rater agreement between multiple independent USCOM users measuring SV and Vpk in hematopoietic malignancy patients whose SBPs drop below 95mmHg or MAPs drop below 65mmHg?
Time frame: 1 day (one time event for patient)
pairs of USCOM measurements from multiple raters for SV and Vpk. We will use the ICC to evaluate rater agreement here, as well, with the same sample size and the same confidence interval. For Aim 2, though, if the second rating cannot be completed within 5 minutes of the first, that episode will be excluded from the study.
In what percentage of patients is fluid bolus administration successful as measured by the current standard of care (MAP) and what is the level of agreement between the standard measure and USCOM readings in determining return to hemodynamic stability?
Time frame: 1 day (one time event for patient)
After two raters have measured SV and Vpk, bolus will be administered. Determining the success of bolus administration, we will simply record whether the clinician judged the bolus to be successful. In addition, one rater will measure SV and Vpk again using USCOM within 5 minutes of bolus administration. We will then calculate the percentage of patients whose stroke volume and peak velocity increased at least 15% after bolus administration using the post-bolus USCOM reading and the same rater's pre-bolus USCOM reading. We chose an increase of 15% based on a review of the research as the threshold that would best indicate a therapeutic response to bolus administration.
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 2 Sep 2013.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
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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.
Michelle Parmentier, RN, BSN principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing USCOM scan and Fluid Bolus in people with Leukemia and Lymphoma, run by Washington University School of Medicine 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 3 inclusion and 4 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 2 Sep 2013. 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?
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?
What is the inter-rater agreement between multiple independent USCOM users measuring stroke volume (SV) and peak velocity (Vpk) whose systolic blood pressures (SBPs) and mean arterial pressures (MAPs) are stable (SBP above 95 mmHg and MAP above 65 mmHg)? (time frame: 1 day (one time event for patient)). The study lists 3 primary outcomes in all. 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 2 Sep 2013.