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HIP Surgery - Hemodynamic Optimization Project (HipHop)

This study is currently recruiting participants.
Verified December 2012 by Charite University, Berlin, Germany
Sponsor:
Collaborator:
Edwards Lifesciences
Information provided by (Responsible Party):
Michael Sander, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01753050
First received: December 17, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

Several studies have demonstrated that goal-directed fluid therapy during high- risk-surgery reduces morbidity and length of hospital stay. This quality improvement is design to evaluate the implementation of an intraoperative goal-directed therapy, using a pulse contour analysis monitor to optimize the stroke volume, in patients undergoing redo-hip-surgery. The primary combined endpoints will be the incidence of postoperative complications and the secondary endpoints will be the decrease of hospital length of stay, length of ICU stay and hospital postoperative mortality.


Condition Intervention
Redo Hip Surgery
 Device: Stroke volume monitoring

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Quality Improvement Project for Goal-directed Intraoperative Hemodynamic Optimization in Patients Redo Hip Surgery

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • postoperative complications [ Time Frame: 30days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • length of hospital and ICU stay [ Time Frame: 30days ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: December 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Stroke volume monitoring
Stroke volume monitoring in all patients
 Device: Stroke volume monitoring
Pulse contour stroke volume monitoring

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients undergoing redo hip surgery
  • age above 18 years
  • signed informed consent

Exclusion Criteria:

  • urgent or emergency surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01753050

Contacts
Contact: Michael Sander, MD +49 30 450 531 ext 012 Michael.Sander@charite.de
Contact: Michael Krämer, MD +4930450531 ext 052 Michael.Kraemer@charite.de

Locations
Germany
Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum Recruiting
Berlin, Germany, 10117
Contact: Michael Sander, MD     +4930450531 ext 052     Michael.Sander@charite.de    
Contact: Michael Krämer, MD     +4930450531 ext 012     Michael.Kraemer@charite.de    
Principal Investigator: Michael Sander, MD Prof.            
Sponsors and Collaborators
Charite University, Berlin, Germany
Edwards Lifesciences
  More Information

No publications provided

Responsible Party: Michael Sander, Prof. Dr., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01753050     History of Changes
Other Study ID Numbers: HipHop, EA1/315/12
Study First Received: December 17, 2012
Last Updated: December 17, 2012
Health Authority: Germany: Ethics Commission

ClinicalTrials.gov processed this record on June 17, 2013