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

NCT02479321 | Completed

• 1 other identifier: CEIC 15/03
• Study Type: interventional
• Target: 568
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Intraoperative arrhythmias

  Intraoperative period

• Postoperative complications

  Postoperative period

• Hospital stay

  Patients will be followed for the duration of hospital stay, an expected median of 11 days

• Survival

  One-year survival

Study Arms (2)

Control group

NO INTERVENTION

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

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

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

Interventions

GDT based on noninvasive monitoring 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.

Also known as: Intraoperative Goal-Directed Hemodynamic Therapy

GDT noninvasive monitoring group

System ClearSight® and Platform EV Clinic 1000® 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.

GDT noninvasive monitoring group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Hip fracture that require surgical treatment
• Agree to participate and sign informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Juan-Víctor Lorente, MD, PhD: lead

Study Sites (1)

Althaia Xarxa Assistencial Universitària de Manresa

Manresa, Barcelona, 08243, Spain

Location

Related Publications (1)

• 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.

  PMID: 35945605 DERIVED

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Joan Bosch Sabater, MD PhD

  Althaia Xarxa Assistencial Universitària de Manresa

  STUDY CHAIR

• Francesca Reguant Corominas, MD PhD

  Althaia Xarxa Assistencial Universitària de Manresa

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: June 15, 2015
• First Posted: June 24, 2015
• Study Start: June 1, 2015
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2019
• Last Updated: December 28, 2021

Record last verified: 2021-12

Locations

ES (1)