Goal Directed Hemodynamic Therapy Based on Noninvasive Monitoring in Patients With Hip Fracture

Study Overview
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Brief Summary
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Crude incidence rate in Spain of hip fracture in people over 65 years was 511 cases per 100,000 in 2002. About 30% of patients die in the first year. Cardiocirculatory complications during and after surgery partly explain this high morbidity and mortality. Most patients are frail and with multicomorbidity. Goal-Directed Hemodynamic Therapy (GDT) based on noninvasive continuous monitoring of blood pressure, heart rate, oxygen saturation, cardiac output, cardiac index, stroke volume and stroke volume index can reduce perioperative complications and improve survival. The objective of our study is to assess the efficacy of a goal-directed hemodynamic therapy in reducing perioperative complications. Patients and Methods: non-randomized intervention study with a historical control and 1-year follow-up. Patients older than 64 years with non-traumatic hip fracture requiring surgical intervention. In the control group standard care was performed based on non-invasive, intermittent arterial pressure measurement, obtained every 5 minutes, continuous heart rate, and oxygen saturation. In the intervention group GDT based on noninvasive monitoring will be performed. The main outcome will be the percentage of patients with perioperative complications. Secondary outcomes: LOS and survival at 12 months of surgery.

Official Title
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Efficacy of Goal Directed Hemodynamic Therapy Based on Noninvasive Monitoring to Reduce Perioperative Complications in Patients With Hip Fracture

Conditions
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Hip Fractures

Intervention / Treatment
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* Other: GDT based on noninvasive monitoring
* Device: System ClearSight® and Platform EV Clinic 1000®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hip fracture that require surgical treatment Agree to participate and sign informed consent Exclusion Criteria: Pathological or traffic related fractures Anesthetic contraindication for surgery Refractures Contraindication for hemodynamic monitoring Physiocal less than 30 after 7 minutes Psychomotor agitation that prevents hemodynamic monitoring

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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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Hemodynamic optimization according to the standards of perioperative monitoring of our center. In the intraoperative period hemodynamic monitoring will be done by management of blood pressure, heart rate and oxygen saturation | |
| Experimental: GDT noninvasive monitoring group<br>GDT based on noninvasive monitoring System ClearSight® and Platform EV Clinic 1000® | Other: GDT based on noninvasive monitoring<br>* Before entering the operating room, hemodynamic optimization start by optimizing preload with Fluid Challenge according to evidence-based GDT protocols. Once stabilized the cardiovascular system after induction of anesthesia, hemodynamic optimization continue with Mini Fluid Challenge. In the intraoperative period, hemodynamic optimization is based on maintaining systolic blood pressure and stroke volume. A Mini Fluid Challenge is administered to patients who respond to volume or a vasoactive drug according cardiac index for non-responders.<br>* Other names: Intraoperative Goal-Directed Hemodynamic Therapy;Device: System ClearSight® and Platform EV Clinic 1000®<br>* Hemodynamic control is held by non-invasive continuous monitoring techniques (system ClearSight® and Platform EV Clinic 1000®). Monitored variables: blood pressure, heart rate, oxygen saturation, cardiac output, cardiac index, stroke volume and stroke volume index.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who developed intraoperative haemodynamic instability | Intraoperative haemodynamic instability, defined as one measurement of SAP < 90 mmHg in the CG and for at least one minute in the IG and/or the need for a bolus of vasoconstrictor. | Intraoperative period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative arrhythmias | Electrocardiographic evidence of cardiac rhythm disturbance. | Intraoperative period | 
| Postoperative complications | Major cardiovascular complications, minor cardiovascular complications, Respiratory, Renal, Infections, Surgical reintervention during hospital stay | Postoperative period | 
| Hospital stay | Length of hospital stay (days) | Patients will be followed for the duration of hospital stay, an expected median of 11 days | 
| Survival |  | One-year survival | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intraoperative Goal Directed Therapy, Fluid therapy, Aged, Perioperative complications, Survival