HIP Surgery - Hemodynamic Optimization Project

NCT ID: NCT01753050

Last Updated: 2019-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

390 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2019-12-31

Brief Summary

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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

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Conditions

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Redo Hip Surgery

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Standard care

No specific hemodynamic optimization measures

Group Type NO_INTERVENTION

No interventions assigned to this group

Hemodynamic optimization

Hemodynamic optimization by stroke volume monitoring

Group Type EXPERIMENTAL

Stroke volume monitoring

Intervention Type DEVICE

Pulse contour stroke volume monitoring

Interventions

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Stroke volume monitoring

Pulse contour stroke volume monitoring

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* urgent or emergency surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Edwards Lifesciences

INDUSTRY

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Sascha Treskatsch

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sascha Treskatsch, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology and Operative Intensive Care Medicine, CCM and CVK

Locations

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Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum

Berlin, , Germany

Site Status

Countries

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Germany

References

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Trauzeddel RF, Leitner M, Dehe L, Nordine M, Piper SK, Habicher M, Sander M, Perka C, Treskatsch S. Goal-directed fluid therapy using uncalibrated pulse contour analysis and balanced crystalloid solutions during hip revision arthroplasty: a quality implementation project. J Orthop Surg Res. 2023 Apr 6;18(1):281. doi: 10.1186/s13018-023-03738-0.

Reference Type DERIVED
PMID: 37024966 (View on PubMed)

Habicher M, Balzer F, Mezger V, Niclas J, Muller M, Perka C, Kramer 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.

Reference Type DERIVED
PMID: 27999663 (View on PubMed)

Other Identifiers

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EA1/315/12

Identifier Type: OTHER

Identifier Source: secondary_id

HipHop

Identifier Type: -

Identifier Source: org_study_id

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