Hip Fractures
Conditions
Keywords
Fluid therapy, Aged, Perioperative complications, Survival, Intraoperative Goal Directed Therapy
Brief summary
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.
Interventions
OTHERGDT based on noninvasive monitoring
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.
DEVICESystem ClearSight® and Platform EV Clinic 1000®
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.
Sponsors
Juan-Víctor Lorente, MD, PhD
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients who developed intraoperative haemodynamic instability | Intraoperative period | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative arrhythmias | Intraoperative period | Electrocardiographic evidence of cardiac rhythm disturbance. |
| Postoperative complications | Postoperative period | Major cardiovascular complications, minor cardiovascular complications, Respiratory, Renal, Infections, Surgical reintervention during hospital stay |
| Hospital stay | Patients will be followed for the duration of hospital stay, an expected median of 11 days | Length of hospital stay (days) |
| Survival | One-year survival | — |
Countries
Spain
Outcome results
None listed