Measurement of Cardiac Output and Intravascular Volume Status in Children Using COstatus (SH)

NCT ID: NCT01613859

Last Updated: 2016-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-05-31

Brief Summary

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Assessment and monitoring of cardiac function in the pediatric intensive care unit (PICU) is an integral part of hemodynamic monitoring of critically ill patients whether it is done directly or indirectly. Measurement of cardiac output (CO) can specifically guide therapies to support the cardiovascular system in critically ill children with multi organ dysfunction. Because of the side effects involved in measuring cardiac output directly, intensive monitoring of patients is currently limited to an integrated assessment of tissue perfusion, oxygen delivery and cellular health both at regional and global levels. Currently available methods of measuring CO have their limitations and complications, and are not used routinely for bedside monitoring. Therefore, the investigators propose to use a newly developed method, termed COstatus for the monitoring of CO in patients admitted to PICU.

Detailed Description

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Conditions

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Intensive Care

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. Patients under 21 years
2. Presence of compensated or decompensated shock irrespective of etiology
3. Presence of an existing peripheral arterial and central venous catheters

Exclusion Criteria

1\. Patients allergic to heparin
Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Transonic Systems Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jai Udassi, MD

Role: PRINCIPAL_INVESTIGATOR

Shands Children's Hospital, University of Florida

Locations

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Shands Children's Hospital, University of Florida

Gainesville, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 18496416 (View on PubMed)

Other Identifiers

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R44HL061994

Identifier Type: NIH

Identifier Source: secondary_id

View Link

TSI-G-COstatus-12A-H

Identifier Type: -

Identifier Source: org_study_id

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