Clinical trial NCT03401138: Hemodynamic Monitoring and Resuscitation in Hip Fractures
Official title: Preoperative Hemodynamic Monitoring and Resuscitation in Hip Fractures: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fracture of Hip
Keywords: Peripheral perfusion
Blood Volume
Tissue Prefusion
Near-infrared spectroscopy
Hemodynamic monitoring
Hemodynamic optimization
Preoperative resuscitation
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2018-01-17
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients presenting a primary acute HF within the study period will be screened for participation by the attending anesthesiologist at the post-anesthesia care unit. The study manager will verify the inclusion and exclusion criteria and inform patients (verbally and in writing) and confirm their agreement to participate by asking them to sign the informed consent document. Assessment of electronic patient records, monitoring and resuscitation treatment and recording of data will be by the study manager.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Primary acute hip fracture
* Age grater than 65 years
* Written informed consent

Exclusion Criteria:

- Contraindications to epidural analgesia

Primary outcomes:
measure: Proportion of patients presenting with preoperative hypovolemia/reduced BV before and after epidural anesthesia
timeFrame: Preoperatively
measure: Proportion of patients with low/very low PPI (PII<1.4 and < 0.5) before and after epidural anesthesia
timeFrame: Preoperatively
measure: Proportion of patients who respond to a 250 ml fluid challenge with sustained rise in SV by at least 10%
timeFrame: Preoperatively
Secondary outcomes:
measure: Correlation between SV, PII and NIRS at normo- and hypovolemia states
timeFrame: Preoperatively
measure: Correlation between PPI and standard microcirculatory variables including lactate, capillary refill time (CRT), and central vs. peripheral temperature
timeFrame: Preoperatively
measure: Correlation between non-invasive Hemoglobin (Hb), BV and arterial Hb
timeFrame: Preoperatively
measure: Proportion of mortality in patients responding to the fluid challenge vs. patients not responding
timeFrame: At 30 days and 1 year
measure: Proportion of postoperative complications in patients responding to the fluid challenge vs. patients not responding
timeFrame: At 30 days and 1 year
measure: Proportion of mortality in patients with high vs. low PPI and NIRS, including impact of BV
timeFrame: At 30 days and 1 year
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Department af Anesthesia, Hvidovre Hospital
state: Copenhagen
Study officials:
affiliation: Department of Anesthesia, Hvidovre Hospital
name: Nicolai Bang Foss, Clinical Professor
role: STUDY_DIRECTOR
affiliation: Department of Anesthesia, Hvidovre Hospital
name: Jakob Højlund, MD, Senior Hospital Physiscian
role: STUDY_CHAIR
affiliation: Abdominal Centre, Department of Anesthesia, Rigshospitalet
name: Henrik Sørensen, MD, DMSc
role: STUDY_CHAIR
affiliation: Abdominal Centre, Department of Anesthesia, Rigshospitalet
name: Niels Secher, Professor, DMSc
role: STUDY_CHAIR
affiliation: Department of Anesthesia, Hvidovre Hospital
name: Marianne Agerskov, MD, Research Fellow
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.