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

Juan-Víctor Lorente, MD, PhD

Status: Completed

Conditions: Hip Fractures

Treatments: Device: System ClearSight® and Platform EV Clinic 1000®; Other: GDT based on noninvasive monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT02479321

CEIC 15/03

Details and patient eligibility

About

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.

Enrollment: 568 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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568 participants in 2 patient groups

Control group

No Intervention group

Description:

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

GDT noninvasive monitoring group

Experimental group

Description:

GDT based on noninvasive monitoring System ClearSight® and Platform EV Clinic 1000®

Treatment:

Device: System ClearSight® and Platform EV Clinic 1000®

Other: GDT based on noninvasive monitoring