Hemodynamic Monitoring and Resuscitation in Hip Fractures
NCT ID: NCT03401138
Last Updated: 2019-10-30
Study Results
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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COMPLETED
50 participants
OBSERVATIONAL
2018-02-14
2019-10-28
Brief Summary
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Methods: The main objective of this prospective observational study is to assess to what extend patients with fracture of the hip suffer from hypovolemia and respond to a fluid challenge. The secondary objectives are to evaluate correlation between the minimally-invasive measurements of stroke volume and blood volume and the non-invasive measurement of peripheral perfusion index and near-infrared spectroscopy, as well as prevalence of postoperative complications and mortality. Fifty consecutive patients over the age of 65 years, presenting with a hip fracture, treated in a multimodal fast-track regimen, will be included when written informed consent is available. All patients will receive epidural analgesia and preoperative stroke volume-guided hemodynamic optimization. Blood volume measurements are performed and all patients are monitored with peripheral perfusion index and near-infrared spectroscopy.
Discussion: This is likely the first study to address clinically applicable hemodynamic monitoring and resuscitation in patients with fracture of the hip where adequate resuscitation is easily missed. The study group aim to evaluate the feasibility of preoperative stroke volume-guided hemodynamic optimization in the context of minimally- and non-invasive monitoring of peripheral perfusion and blood volume measurements.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Preoperative Stroke Volume(SV)-guided fluid optimization
Preoperative SV-guided hemodynamic optimization will be commenced with patients receiving 250ml fluid challenges over five minutes aiming to maximize SV. Maximal SV is defined as absence of a sustained rise in SV by at least 10% in response to a fluid challenge.
PPI will be obtained from the Masimo Radical 7 (Masimo, Irvine, CA, USA) and NIRS from Invos 5100C (Medtronic, Minneapolis, MN, USA).
BV measurements will use pulse dye densitometry (PDD) with Indocyanine Green (ICG). We will use the Dye Densitogram 3300 analyser Nihon Kohden (Tokyo, Japan) for registration of the spectrophotometrical absorption of ICG and calculation of BV.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age grater than 65 years
* Written informed consent
Exclusion Criteria
65 Years
ALL
No
Sponsors
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Hvidovre University Hospital
OTHER
Responsible Party
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Marianne Agerskov
MD, Reseach Fellow
Principal Investigators
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Nicolai Bang Foss, Clinical Professor
Role: STUDY_DIRECTOR
Department of Anesthesia, Hvidovre Hospital
Jakob Højlund, MD, Senior Hospital Physiscian
Role: STUDY_CHAIR
Department of Anesthesia, Hvidovre Hospital
Henrik Sørensen, MD, DMSc
Role: STUDY_CHAIR
Abdominal Centre, Department of Anesthesia, Rigshospitalet
Niels Secher, Professor, DMSc
Role: STUDY_CHAIR
Abdominal Centre, Department of Anesthesia, Rigshospitalet
Marianne Agerskov, MD, Research Fellow
Role: PRINCIPAL_INVESTIGATOR
Department of Anesthesia, Hvidovre Hospital
Locations
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Department af Anesthesia, Hvidovre Hospital
Hvidovre, Copenhagen, Denmark
Countries
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References
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Agerskov M, Sorensen H, Hojlund J, Secher NH, Foss NB. Pre-operative haemodynamic monitoring and resuscitation in hip fracture patients: Protocol for a prospective observational study. Acta Anaesthesiol Scand. 2018 Oct;62(9):1314-1320. doi: 10.1111/aas.13163. Epub 2018 May 30.
Other Identifiers
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H- 17037633
Identifier Type: -
Identifier Source: org_study_id
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