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

Hip Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02479321
• Other study ID #: CEIC 15/03
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: February 2019

Study information

• Verified date: December 2021
• Source: Althaia Xarxa Assistencial Universitària de Manresa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 568
• Est. completion date: February 2019
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures

Intervention

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.

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.

Locations

Country	Name	City	State
Spain	Althaia Xarxa Assistencial Universitària de Manresa	Manresa	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Juan-Víctor Lorente, MD, PhD

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Intraoperative arrhythmias	Electrocardiographic evidence of cardiac rhythm disturbance.	Intraoperative period
Secondary	Postoperative complications	Major cardiovascular complications, minor cardiovascular complications, Respiratory, Renal, Infections, Surgical reintervention during hospital stay	Postoperative period
Secondary	Hospital stay	Length of hospital stay (days)	Patients will be followed for the duration of hospital stay, an expected median of 11 days
Secondary	Survival		One-year survival