Study of Hypotensive Hematopoietic Malignancy Patients' USCOM Readings

Multiple Myeloma Clinical Trial

Official title:

A Pilot Feasibility Study of Hypotensive Hematopoietic Malignancy Patients' USCOM Readings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01755000
• Other study ID #: 201206070
• Status: Completed
• Phase: N/A
• First received: December 18, 2012
• Last updated: August 30, 2013
• Start date: December 2012
• Est. completion date: April 2013

Study information

• Verified date: August 2013
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Leukemia
• Lymphoma
• Multiple Myeloma
• Myelodysplastic Syndromes
• Paraproteinemias
• Preleukemia

Intervention

Procedure:
• USCOM scan

• Fluid Bolus

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 day (one time event for patient)	No
Primary	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.	1 day (one time event for patient)	No
Primary	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.	1 day (one time event for patient)	No

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine