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HIP Surgery - Hemodynamic Optimization Project (HipHop)

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ClinicalTrials.gov Identifier: NCT01753050
Recruitment Status : Active, not recruiting
First Posted : December 20, 2012
Last Update Posted : July 24, 2019
Sponsor:
Collaborator:
Edwards Lifesciences
Information provided by (Responsible Party):
Sascha Treskatsch, Charite University, Berlin, Germany

Brief Summary:
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 or disease Intervention/treatment Phase
Redo Hip Surgery Device: Stroke volume monitoring Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 390 participants
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
Study Start Date : December 2012
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
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




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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


Locations
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Germany
Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Edwards Lifesciences
Investigators
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Principal Investigator: Sascha Treskatsch, MD Department of Anesthesiology and Operative Intensive Care Medicine, CCM and CVK

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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 Posted: December 20, 2012    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019