HIP Surgery - Hemodynamic Optimization Project (HipHop)

July 23, 2019 updated by: Sascha Treskatsch, Charite University, Berlin, Germany

A Quality Improvement Project for Goal-directed Intraoperative Hemodynamic Optimization in Patients Redo Hip Surgery

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

390

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • urgent or emergency surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
postoperative complications
Time Frame: 30days
30days

Secondary Outcome Measures

Outcome Measure
Time Frame
length of hospital and ICU stay
Time Frame: 30days
30days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

Edwards Lifesciences

Investigators

  • Principal Investigator: Sascha Treskatsch, MD, Department of Anesthesiology and Operative Intensive Care Medicine, CCM and CVK

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

December 17, 2012

First Submitted That Met QC Criteria

December 17, 2012

First Posted (Estimate)

December 20, 2012

Study Record Updates

Last Update Posted (Actual)

July 24, 2019

Last Update Submitted That Met QC Criteria

July 23, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • HipHop
  • EA1/315/12 (Other Identifier: ethics commitee)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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