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Completed

NCT Number: NCT02479321

Goal Directed Hemodynamic Therapy Based on Noninvasive Monitoring 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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Althaia Xarxa Assistencial Universitària de Manresa

Manresa, Barcelona, 08243, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Intraoperative Goal-Directed Hemodynamic Therapy

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.

Primary outcomes

  1. Percentage of patients who developed intraoperative haemodynamic instability

    Time frame: Intraoperative period

    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 outcomes

  1. Intraoperative arrhythmias

    Time frame: Intraoperative period

    Electrocardiographic evidence of cardiac rhythm disturbance.

  2. Postoperative complications

    Time frame: Postoperative period

    Major cardiovascular complications, minor cardiovascular complications, Respiratory, Renal, Infections, Surgical reintervention during hospital stay

  3. Hospital stay

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

    Length of hospital stay (days)

  4. Survival

    Time frame: One-year survival

Sponsors and collaborators

Lead sponsor

Juan-Víctor Lorente, MD, PhD

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Jun 24, 2015
Registry last updated
Dec 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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