Althaia Xarxa Assistencial Universitària de Manresa
Manresa, Barcelona, 08243, Spain
NCT Number: NCT02479321
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.
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Notify Me65 year and older
All sexes
Interventional
Not applicable
Manresa, Barcelona, 08243, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Intraoperative Goal-Directed Hemodynamic Therapy
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.
Time frame: 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.
Time frame: Intraoperative period
Electrocardiographic evidence of cardiac rhythm disturbance.
Time frame: Postoperative period
Major cardiovascular complications, minor cardiovascular complications, Respiratory, Renal, Infections, Surgical reintervention during hospital stay
Time frame: Patients will be followed for the duration of hospital stay, an expected median of 11 days
Length of hospital stay (days)
Time frame: One-year survival
Juan-Víctor Lorente, MD, PhD
Other
Efficacy of Goal Directed Hemodynamic Therapy Based on Noninvasive Monitoring to Reduce Perioperative Complications in Patients With Hip Fracture
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