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Hypotension Probability Index in Anesthesia

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ClinicalTrials.gov Identifier: NCT03663270
Recruitment Status : Completed
First Posted : September 10, 2018
Last Update Posted : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Christian Koch, University of Giessen

Brief Summary:
The aim of the study is to investigate the value of the Hypotension Probability Index in reducing intraoperative hypotension in patients with primary hip replacement. The measurement of the blood pressure was and is of great interest for the treating physician/anesthesiologist to optimize the peri- and postoperative patients outcome. The non-invasive measurement can scale the blood pressure but not from heartbeat-to-heartbeat, what results in a loss of information. The invasive measurement by a placed catheter in an artery shows the blood pressure with information about the pulse wave form, the ascending angle, and makes it possible to detect hemodynamic changes in a way the non-invasive blood pressure measurement is lacking. The additional informations of the monitoring and a

Condition or disease Intervention/treatment Phase
Hip Disease Hypotension Surgery Anesthesia Device: Hypotension probability index (HPI) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized two arm study with two groups
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: Computer generated random list
Primary Purpose: Treatment
Official Title: Influence of the "Hypotension Probability Index" on the Number and Duration of Intraoperative Hypotension in Primary Hip Endoprosthetic Replacement
Actual Study Start Date : June 22, 2017
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : October 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Intervention arm
HPI monitoring to predict hypotension
Device: Hypotension probability index (HPI)
The intervention group is managed with the HPI parameter to detect and possibly prevent hypotension during anaesthesia.

No Intervention: Control arm
blinded HPI monitoring



Primary Outcome Measures :
  1. Episode of hypotension [ Time Frame: up to 18 months ]
    The aim of the study is to investigate whether a goal directed treatment according to the Hypotension Probability Index compared to standard care can reduce the incidence of intraoperative hypotension in patients with hip-replacement. As primary endpoints frequency (n)/h, absolute and relative duration (t [min]/% of total anesthesia time) of intraoperative hypotension were defined for this study.


Secondary Outcome Measures :
  1. Changes of fluid management [ Time Frame: up to 18 months ]
    Amount of of intravenous fluids (ml of crystalloids, ml of colloids)

  2. Changes of catecholamine management [ Time Frame: up to 18 months ]
    Dosage of vasopressors and inotropes (µg)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing hip-replacement

    • General anesthesia
    • Age ≥ 18 years

Exclusion Criteria:

  • Participation in another (interventional) study

    • Pregnancy and nursing mothers
    • Surgery without controlled ventilation
    • ASA > III
    • Contraindication for invasive blood pressure monitoring
    • Renal insufficiency KDIGO Stadium ≥ 2
    • Coagulation disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03663270


Locations
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Germany
Michael Sander
Gießen, Germany, 35392
Sponsors and Collaborators
University of Giessen
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Christian Koch, MD, Principal investigator, University of Giessen
ClinicalTrials.gov Identifier: NCT03663270    
Other Study ID Numbers: 09/17
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Christian Koch, University of Giessen:
goal directed management
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases