This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

HIP Surgery - Hemodynamic Optimization Project (HipHop)

This study has been completed.
Sponsor:
Collaborator:
Edwards Lifesciences
Information provided by (Responsible Party):
Sascha Treskatsch, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01753050
First received: December 17, 2012
Last updated: January 27, 2016
Last verified: January 2016
  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
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 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 ]

Enrollment: 260
Study Start Date: December 2012
Study Completion Date: June 2014
Primary Completion Date: April 2014 (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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01753050

Locations
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
  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 )
Study First Received: December 17, 2012
Last Updated: January 27, 2016

ClinicalTrials.gov processed this record on June 22, 2017