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LiDCO Monitor Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joseph D. Tobias, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01567371
First received: March 26, 2012
Last updated: March 16, 2016
Last verified: March 2016
Results First Received: March 16, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Cardiac Surgery
Intervention: Device: LiDCO rapid monitor

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
LiDCO Rapid Monitor No text entered.

Participant Flow:   Overall Study
    LiDCO Rapid Monitor
STARTED   30 
COMPLETED   30 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
LiDCO Rapid Monitor No text entered.

Baseline Measures
   LiDCO Rapid Monitor 
Overall Participants Analyzed 
[Units: Participants]
 30 
Age 
[Units: Participants]
 
<=18 years   16 
Between 18 and 65 years   14 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 21.5  (11.018) 
Gender 
[Units: Participants]
 
Female   15 
Male   15 
Region of Enrollment 
[Units: Participants]
 
United States   30 


  Outcome Measures
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1.  Primary:   Difference in Pulse Pressure Variability From Baseline to Post-ANH   [ Time Frame: 1 Day ]

2.  Secondary:   Difference in Stroke Volume Variability From Baseline to Post ANH.   [ Time Frame: 1 Day ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Joseph D. Tobias, MD
Organization: Nationwide Children's Hospital
phone: 614-722-4200
e-mail: Joseph.Tobias@nationwidechildrens.org



Responsible Party: Joseph D. Tobias, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01567371     History of Changes
Other Study ID Numbers: IRB12-00096
Study First Received: March 26, 2012
Results First Received: March 16, 2016
Last Updated: March 16, 2016
Health Authority: United States: Institutional Review Board