Study of Hypotensive Hematopoietic Malignancy Patients' USCOM Readings
NCT ID: NCT01755000
Last Updated: 2013-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
69 participants
INTERVENTIONAL
2012-12-31
2013-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Aim 1: Hemodynamically Healthy Patients
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
USCOM scan
Aim 2: Hemodynamically Unstable Patients
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.
USCOM scan
Aim 3: Hemodynamically Unstable Patients + Fluid Bolus
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.
USCOM scan
Fluid Bolus
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
USCOM scan
Fluid Bolus
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* English speaker
* Diagnosis of blood dyscrasia, hematopoietic malignancy, or condition that may requires HSCT
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Washington University School of Medicine
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michelle Parmentier, RN, BSN
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Washington University School of Medicine
St Louis, Missouri, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
201206070
Identifier Type: -
Identifier Source: org_study_id