Study of Hypotensive Hematopoietic Malignancy Patients' USCOM Readings

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01755000
First received: December 18, 2012
Last updated: August 30, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Leukemia
Lymphoma
Paraproteinemias
Multiple Myeloma
Myelodysplastic Syndromes
Procedure: USCOM scan
Procedure: Fluid Bolus

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Pilot Feasibility Study of Hypotensive Hematopoietic Malignancy Patients' USCOM Readings

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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.


Enrollment: 69
Study Start Date: December 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Procedure: 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.

Procedure: 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.

Procedure: USCOM scan Procedure: Fluid Bolus

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-≥ 18 years of age

  • English speaker
  • Diagnosis of blood dyscrasia, hematopoietic malignancy, or condition that may requires HSCT

Exclusion Criteria:

  • 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
  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: NCT01755000

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Michelle Parmentier, RN, BSN Washington University School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01755000     History of Changes
Other Study ID Numbers: 201206070
Study First Received: December 18, 2012
Last Updated: August 30, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Leukemia
Lymphoma
Multiple Myeloma
Neoplasms, Plasma Cell
Myelodysplastic Syndromes
Preleukemia
Paraproteinemias
Hematologic Neoplasms
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases
Precancerous Conditions
Neoplasms by Site
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014