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HIP Surgery - Hemodynamic Optimization Project (HipHop)

This study is currently recruiting participants.
Verified July 2017 by Sascha Treskatsch, Charite University, Berlin, Germany
Sponsor:
ClinicalTrials.gov Identifier:
NCT01753050
First Posted: December 20, 2012
Last Update Posted: July 27, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Edwards Lifesciences
Information provided by (Responsible Party):
Sascha Treskatsch, Charite University, Berlin, Germany
  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. We amended another 130 patients getting crystalloid fluids in the hemodynamic optimization protocol.

Condition Intervention
Redo Hip Surgery Device: Stroke volume monitoring

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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 Sascha Treskatsch, Charite University, Berlin, Germany:

Primary Outcome Measures:
  • postoperative complications [ Time Frame: 30days ]

Secondary Outcome Measures:
  • length of hospital and ICU stay [ Time Frame: 30days ]

Estimated Enrollment: 390
Study Start Date: December 2012
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard care
No specific hemodynamic optimization measures
Experimental: Hemodynamic optimization
Hemodynamic optimization by stroke volume monitoring
Device: Stroke volume monitoring
Pulse contour stroke volume monitoring

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01753050


Contacts
Contact: Sascha Treskatsch, 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: Sascha Treskatsch, MD    +4930450531 ext 052    sascha.treskatsch@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
Investigators
Principal Investigator: Sascha Treskatsch, MD Department of Anesthesiology and Operative Intensive Care Medicine, CCM and CVK
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sascha Treskatsch, Dr., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01753050     History of Changes
Other Study ID Numbers: HipHop
EA1/315/12 ( Other Identifier: ethics commitee )
First Submitted: December 17, 2012
First Posted: December 20, 2012
Last Update Posted: July 27, 2017
Last Verified: July 2017