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

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

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.

Study Overview

• Status: Completed
• Conditions: Hip Fractures
• Intervention / Treatment: Other: GDT based on noninvasive monitoring; Device: System ClearSight® and Platform EV Clinic 1000®

• Study Type: Interventional
• Enrollment (Actual): 568
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Manresa, Barcelona, Spain, 08243
      • Althaia Xarxa Assistencial Universitària de Manresa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; 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; GDT based on noninvasive monitoring System ClearSight® and Platform EV Clinic 1000®	Other: GDT 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.; Other Names: Intraoperative Goal-Directed Hemodynamic Therapy; Device: System 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Juan-Víctor Lorente, MD, PhD
• Investigators: Study Chair: Joan Bosch Sabater, MD PhD, Althaia Xarxa Assistencial Universitària de Manresa; Study Chair: Francesca Reguant Corominas, MD PhD, Althaia Xarxa Assistencial Universitària de Manresa

Publications and helpful links

General Publications

• Lorente JV, Reguant F, Arnau A, Borderas M, Prieto JC, Torrallardona J, Carrasco L, Solano P, Perez I, Farre C, Jimenez I, Ripolles-Melchor J, Monge MI, Bosch J. Effect of goal-directed haemodynamic therapy guided by non-invasive monitoring on perioperative complications in elderly hip fracture patients within an enhanced recovery pathway. Perioper Med (Lond). 2022 Aug 10;11(1):46. doi: 10.1186/s13741-022-00277-w.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: June 15, 2015
• First Submitted That Met QC Criteria: June 23, 2015
• First Posted (Estimate): June 24, 2015

Study Record Updates

• Last Update Posted (Actual): December 28, 2021
• Last Update Submitted That Met QC Criteria: December 22, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Survival; Fluid therapy; Aged; Perioperative complications; Intraoperative Goal Directed Therapy
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: CEIC 15/03