HIP Surgery - Hemodynamic Optimization Project

Redo Hip Surgery Clinical Trial

— HipHop  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01753050
• Other study ID #: HipHop
• Secondary ID: EA1/315/12
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 2012
• Est. completion date: December 2019

Study information

• Verified date: July 2019
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 390
• Est. completion date: December 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients undergoing redo hip surgery

• age above 18 years

• signed informed consent

Exclusion Criteria:

• urgent or emergency surgery

Related Conditions & MeSH terms

• Redo Hip Surgery

Intervention

Device:
• Stroke volume monitoring
Pulse contour stroke volume monitoring

Locations

Country	Name	City	State
Germany	Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Edwards Lifesciences

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative complications		30days
Secondary	length of hospital and ICU stay		30days