Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

HIP Surgery - Hemodynamic Optimization Project (HipHop)

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. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE December 17, 2012
First Posted Date  ICMJE December 20, 2012
Last Update Posted Date July 24, 2019
Study Start Date  ICMJE December 2012
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 17, 2012)
postoperative complications [ Time Frame: 30days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01753050 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2012)
length of hospital and ICU stay [ Time Frame: 30days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE HIP Surgery - Hemodynamic Optimization Project
Official Title  ICMJE A Quality Improvement Project for Goal-directed Intraoperative Hemodynamic Optimization in Patients Redo Hip Surgery
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Redo Hip Surgery
Intervention  ICMJE Device: Stroke volume monitoring
Pulse contour stroke volume monitoring
Study Arms  ICMJE
  • No Intervention: Standard care
    No specific hemodynamic optimization measures
  • Experimental: Hemodynamic optimization
    Hemodynamic optimization by stroke volume monitoring
    Intervention: Device: Stroke volume monitoring
Publications * Habicher M, Balzer F, Mezger V, Niclas J, Müller M, Perka C, Krämer M, Sander M. Implementation of goal-directed fluid therapy during hip revision arthroplasty: a matched cohort study. Perioper Med (Lond). 2016 Dec 13;5:31. doi: 10.1186/s13741-016-0056-x. eCollection 2016.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: July 25, 2017)
390
Original Estimated Enrollment  ICMJE
 (submitted: December 17, 2012)
130
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • urgent or emergency surgery
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01753050
Other Study ID Numbers  ICMJE HipHop
EA1/315/12 ( Other Identifier: ethics commitee )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sascha Treskatsch, Charite University, Berlin, Germany
Study Sponsor  ICMJE Charite University, Berlin, Germany
Collaborators  ICMJE Edwards Lifesciences
Investigators  ICMJE
Principal Investigator: Sascha Treskatsch, MD Department of Anesthesiology and Operative Intensive Care Medicine, CCM and CVK
PRS Account Charite University, Berlin, Germany
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP