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

NCT ID: NCT02479321

Last Updated: 2021-12-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 568 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2019-02-28

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.

Conditions

Hip Fractures

Keywords

Fluid therapy; Aged; Perioperative complications; Survival; Intraoperative Goal Directed Therapy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

GDT noninvasive monitoring group

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

Group Type: EXPERIMENTAL

GDT based on noninvasive monitoring

Intervention Type: OTHER

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.

System ClearSight® and Platform EV Clinic 1000®

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: DEVICE

Other Intervention Names

Intraoperative Goal-Directed Hemodynamic Therapy

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Juan-Víctor Lorente, MD, PhD

OTHER

Sponsor Role: lead

Responsible Party

Juan-Víctor Lorente, MD, PhD

Medical Doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Joan Bosch Sabater, MD PhD

Role: STUDY_CHAIR

Althaia Xarxa Assistencial Universitària de Manresa

Francesca Reguant Corominas, MD PhD

Role: STUDY_CHAIR

Althaia Xarxa Assistencial Universitària de Manresa

Locations

Althaia Xarxa Assistencial Universitària de Manresa

Manresa, Barcelona, Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 35945605 (View on PubMed)

Other Identifiers

CEIC 15/03

Identifier Type: -

Identifier Source: org_study_id