Hemodynamic Monitoring and Resuscitation in Hip Fractures

Study Overview
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Brief Summary
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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.

Official Title
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Preoperative Hemodynamic Monitoring and Resuscitation in Hip Fractures: a Prospective Observational Study

Conditions
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Fracture of Hip

Intervention / Treatment
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* Other: Preoperative Stroke Volume(SV)-guided fluid optimization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary acute hip fracture Age grater than 65 years Written informed consent Exclusion Criteria: - Contraindications to epidural analgesia

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients presenting with preoperative hypovolemia/reduced BV before and after epidural anesthesia |  | Preoperatively | 
| Proportion of patients with low/very low PPI (PII<1.4 and < 0.5) before and after epidural anesthesia |  | Preoperatively | 
| Proportion of patients who respond to a 250 ml fluid challenge with sustained rise in SV by at least 10% |  | Preoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between SV, PII and NIRS at normo- and hypovolemia states |  | Preoperatively | 
| Correlation between PPI and standard microcirculatory variables including lactate, capillary refill time (CRT), and central vs. peripheral temperature |  | Preoperatively | 
| Correlation between non-invasive Hemoglobin (Hb), BV and arterial Hb |  | Preoperatively | 
| Proportion of mortality in patients responding to the fluid challenge vs. patients not responding |  | At 30 days and 1 year | 
| Proportion of postoperative complications in patients responding to the fluid challenge vs. patients not responding |  | At 30 days and 1 year | 
| Proportion of mortality in patients with high vs. low PPI and NIRS, including impact of BV |  | At 30 days and 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral perfusion, Blood Volume, Tissue Prefusion, Near-infrared spectroscopy, Hemodynamic monitoring, Hemodynamic optimization, Preoperative resuscitation