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

Primary Purpose

Hip Fractures

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
GDT based on noninvasive monitoring
System ClearSight® and Platform EV Clinic 1000®
Sponsored by
Juan-Víctor Lorente, MD, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fractures focused on measuring Fluid therapy, Aged, Perioperative complications, Survival, Intraoperative Goal Directed Therapy

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Althaia Xarxa Assistencial Universitària de Manresa

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

GDT noninvasive monitoring group

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Intraoperative arrhythmias
Electrocardiographic evidence of cardiac rhythm disturbance.
Postoperative complications
Major cardiovascular complications, minor cardiovascular complications, Respiratory, Renal, Infections, Surgical reintervention during hospital stay
Hospital stay
Length of hospital stay (days)
Survival

Full Information

First Posted
June 15, 2015
Last Updated
December 22, 2021
Sponsor
Juan-Víctor Lorente, MD, PhD
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1. Study Identification

Unique Protocol Identification Number
NCT02479321
Brief Title
Goal Directed Hemodynamic Therapy Based on Noninvasive Monitoring in Patients With Hip Fracture
Official Title
Efficacy of Goal Directed Hemodynamic Therapy Based on Noninvasive Monitoring to Reduce Perioperative Complications in Patients With Hip Fracture
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Juan-Víctor Lorente, MD, PhD

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures
Keywords
Fluid therapy, Aged, Perioperative complications, Survival, Intraoperative Goal Directed Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
568 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
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
Arm Title
GDT noninvasive monitoring group
Arm Type
Experimental
Arm Description
GDT based on noninvasive monitoring System ClearSight® and Platform EV Clinic 1000®
Intervention Type
Other
Intervention Name(s)
GDT based on noninvasive monitoring
Other Intervention Name(s)
Intraoperative Goal-Directed Hemodynamic Therapy
Intervention Description
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
Device
Intervention Name(s)
System ClearSight® and Platform EV Clinic 1000®
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of patients who developed intraoperative haemodynamic instability
Description
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.
Time Frame
Intraoperative period
Secondary Outcome Measure Information:
Title
Intraoperative arrhythmias
Description
Electrocardiographic evidence of cardiac rhythm disturbance.
Time Frame
Intraoperative period
Title
Postoperative complications
Description
Major cardiovascular complications, minor cardiovascular complications, Respiratory, Renal, Infections, Surgical reintervention during hospital stay
Time Frame
Postoperative period
Title
Hospital stay
Description
Length of hospital stay (days)
Time Frame
Patients will be followed for the duration of hospital stay, an expected median of 11 days
Title
Survival
Time Frame
One-year survival

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan Bosch Sabater, MD PhD
Organizational Affiliation
Althaia Xarxa Assistencial Universitària de Manresa
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Francesca Reguant Corominas, MD PhD
Organizational Affiliation
Althaia Xarxa Assistencial Universitària de Manresa
Official's Role
Study Chair
Facility Information:
Facility Name
Althaia Xarxa Assistencial Universitària de Manresa
City
Manresa
State/Province
Barcelona
ZIP/Postal Code
08243
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
35945605
Citation
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.
Results Reference
derived

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

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