Measurement of Cardiac Output and Blood Volumes | NCT00851474

Studies
Measurement of Cardiac Output and Blood Volumes

NCT00851474

Sponsor

Transonic Systems Inc.

Status

Withdrawn

Last Update Posted

May 27, 2016Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Cardiac Output

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2R44HL061994-04A2	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Protocol not renewed

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

May 2011Actual

Completion Date

May 2011Actual

First Submitted Date

Feb 25, 2009

First Submission Date that Met QC Criteria

Feb 25, 2009

First Posted Date

Feb 26, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 25, 2016

Last Update Posted Date

May 27, 2016Estimated

Name	Class
National Heart, Lung, and Blood Institute (NHLBI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Cardiac Output (amount of blood pumped by the heart in one minute) will be measured using the new COstatus(R) system and these values will be compared with cardiac output values measured by other methods such as thermodilution. Blood volumes measured by the COstatus(R) system will also be recorded.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Compare cardiac output measured by COstatus(R) with other methods such as PA Thermodilution		5-8 minutes minimum

Secondary Outcomes

Measure	Description	Time Frame
Measure blood volumes		5-8 minutes minimum

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients (older than 18 years of age)
Should have both arterial and central venous catheters already in place

Exclusion Criteria:

Patients who do not have either the arterial or central venous catheters.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients (older than 18 years of age) in the Intensive Care Unit with arterial and central venous catheters in place.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lawrence Diebel, MD	Wayne State University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wayne State University		Detroit	Michigan	48201	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18496416	Background	Krivitski NM, Kislukhin VV, Thuramalla NV. Theory and in vitro validation of a new extracorporeal arteriovenous loop approach for hemodynamic assessment in pediatric and neonatal intensive care unit patients. Pediatr Crit Care Med. 2008 Jul;9(4):423-8. doi: 10.1097/01.PCC.0b013e31816c71bc.