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

Not Applicable

Completed

• Conditions: Hip Fractures
• Interventions: Other: GDT based on noninvasive monitoring; Device: System ClearSight® and Platform EV Clinic 1000®

• Registration Number: NCT02479321
• Lead Sponsor: Juan-Víctor Lorente, MD, PhD

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-15
• Study First Submitted QC: 2015-06-23
• Study First Posted: 2015-06-24
• Primary Completion: 2018-02
• Study Completion: 2019-02
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-22
• Last Update Posted: 2021-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 568

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GDT noninvasive monitoring group	System ClearSight® and Platform EV Clinic 1000®	GDT based on noninvasive monitoring System ClearSight® and Platform EV Clinic 1000®
GDT noninvasive monitoring group	GDT based on noninvasive monitoring	GDT based on noninvasive monitoring System ClearSight® and Platform EV Clinic 1000®

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Survival	One-year survival
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)

Trial Locations

Locations (1)

Althaia Xarxa Assistencial Universitària de Manresa; 🇪🇸 Manresa, Barcelona, Spain