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GDT by Cardiac Index Trending Via a Radial Arterial Line in General Surgery

This study has been completed.
Sponsor:
Collaborators:
Northern State Medical University
Szeged University
University of Kiel
University of Witten/Herdecke
University of Valencia
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01401283
First received: July 8, 2011
Last updated: January 6, 2016
Last verified: January 2016
Results First Received: December 1, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Reduction of Length of Hospitality Stay, Reduction of Perioperative Complications
Intervention: Device: measurement of cardiac output and pulse pressure variation

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Study Group

intraoperative guidance of hemodynamics by measures of cardiac index and pulse pressure variation

measurement of cardiac output and pulse pressure variation: hemodynamic optimization according to cardiac index and pulse pressure variation

Control Group hemodynamic management according to institutional clinical standards

Participant Flow:   Overall Study
    Study Group   Control Group
STARTED   89   91 
COMPLETED   79   81 
NOT COMPLETED   10   10 
surgery cancelled                5                8 
preoperative arrhythmia                5                0 
no central venous access                0                1 
suspicion of malignant hyperthermia                0                1 



  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.
No text entered.

Reporting Groups
  Description
Study Group

intraoperative guidance of hemodynamics by measures of cardiac index and pulse pressure variation

measurement of cardiac output and pulse pressure variation: hemodynamic optimization according to cardiac index and pulse pressure variation

Control Group hemodynamic management according to institutional clinical standards
Total Total of all reporting groups

Baseline Measures
   Study Group   Control Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 89   91   180 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   64   55   119 
>=65 years   25   36   61 
Gender 
[Units: Participants]
     
Female   37   36   73 
Male   52   55   107 
Region of Enrollment 
[Units: Participants]
     
Germany   89   91   180 


  Outcome Measures
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1.  Primary:   Postoperative Complications   [ Time Frame: Participants will be followed from end of surgery for the duration of stay in the recovery room, for the duration of the complete hospital stay, an expected average of ten 10 days ]

2.  Secondary:   Hospital Stay   [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Daniel A. Reuter, MD
Organization: Hamburg Eppendorf University Hospital
phone: +49-40-7410-0
e-mail: dreuter@uke.de


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT01401283     History of Changes
Other Study ID Numbers: 797726
Study First Received: July 8, 2011
Results First Received: December 1, 2015
Last Updated: January 6, 2016
Health Authority: Germany: Ethics Commission