Fracture of Hip Clinical Trial
Official title:
Preoperative Hemodynamic Monitoring and Resuscitation in Hip Fractures: a Prospective Observational Study
Background: Fracture of the hip is a potentially fatal event in an elderly, frail, highly
comorbid patient group suffering from dehydration and hypovolemia, and it carries a risk that
equals major trauma in young patients in regard of physiological insult and severity, yet no
preoperative resuscitation and transfusion strategy is available. An important goal of
hemodynamic monitoring and resuscitation is early detection of insufficient tissue perfusion
and oxygenation. The peripheral perfusion index reflects changes in peripheral perfusion and
blood volume and a decreased peripheral perfusion index predicts surgical complications and
morbidity in acute surgical and septic shock patients. The research group hypothesize that
elderly frail patients with a fracture of the hip suffer from hypovolemia and peripheral
hypoperfusion of varying degrees and accordingly respond to controlled fluid resuscitation
and that the non-invasive peripheral perfusion index will serve as an early predictor of a
deteriorated circulation in reflection of stroke volume.
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.
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05530174 -
Effect of Single vs Multiple Prophylactic Antibiotic Doses on PJI Following Primary THA in Patients With a Fracture
|
N/A | |
Completed |
NCT03224195 -
Patient Experience of Acute Rehabilitation After Hip Fracture
|
||
Active, not recruiting |
NCT03795467 -
Peripheral Perfusion Index, Haemoglobin and Blood Transfusion in Acute Surgical Patients
|
||
Recruiting |
NCT04906265 -
Rehab After Hip Fracture With Wearable Device
|
N/A | |
Not yet recruiting |
NCT06024304 -
InterTAN: Integrated Dual Screw Design Improve Biomechanics/Function Following Fixation Surgery
|
N/A | |
Recruiting |
NCT04754087 -
G7 Acetabular System With Vivacit-E or Longevity Liner PMCF Study
|
N/A | |
Completed |
NCT04079127 -
Avenir Müller Hip Stem Post Market Surveillance Study
|
||
Completed |
NCT03757442 -
Peripheral Perfusion Index in Acute Surgical Patients
|
||
Terminated |
NCT03648775 -
Evaluation of the Clinical Efficacy of Y-STRUT® Medical Device Implanted for Contralateral Percutaneous Internal Fixation of Proximal Femur, in Patient With a Low Energy Per Trochanteric Fracture on the First Side
|
||
Completed |
NCT05965544 -
The Effect of Fascia Iliaca Compartment Block (FICB) on QoR-15 Score in Partial Hip Arthroplasty Surgery
|
N/A | |
Suspended |
NCT04455789 -
Mechanical Ventilation Based on Driving Pressure in Lateral Position
|
N/A | |
Terminated |
NCT04079114 -
Post Market Clinical Follow-Up of the Zimmer Stafit Acetabular System
|