LiDCO Monitor Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01567371
Recruitment Status : Completed
First Posted : March 30, 2012
Results First Posted : April 15, 2016
Last Update Posted : April 15, 2016
Information provided by (Responsible Party):
Joseph D. Tobias, Nationwide Children's Hospital

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition: Cardiac Surgery
Intervention: Device: LiDCO rapid monitor

  Participant Flow

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
LiDCO Rapid Monitor No text entered.

Participant Flow:   Overall Study
    LiDCO Rapid Monitor

  Baseline Characteristics

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
LiDCO Rapid Monitor No text entered.

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

  Outcome Measures

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

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

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

Responsible Party: Joseph D. Tobias, Nationwide Children's Hospital Identifier: NCT01567371     History of Changes
Other Study ID Numbers: IRB12-00096
First Submitted: March 26, 2012
First Posted: March 30, 2012
Results First Submitted: March 16, 2016
Results First Posted: April 15, 2016
Last Update Posted: April 15, 2016