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

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ClinicalTrials.gov Identifier: NCT02479321
Recruitment Status : Recruiting
First Posted : June 24, 2015
Last Update Posted : June 29, 2018
Sponsor:
Information provided by (Responsible Party):
Juan Víctor, Althaia Xarxa Assistencial Universitària de Manresa

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. Perioperative Goal-Directed Hemodynamic Therapy (PGDT) 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 during the perioperative period in reducing intraoperative complications, especially hemodynamic instability, postoperative complications and 1-year survival. 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 blood pressure, heart rate, oxygen saturation and clinical situation besides respiratory parameters were recorded at intervals of 15 minutes. In the intervention group PGDT based on noninvasive monitoring will be performed. The main outcome will be the percentage of patients with hemodynamic instability complications and the average of complications per patient. Secondary outcomes: intraoperative complications, postoperative complications and survival at 12 months of surgery.

Condition or disease Intervention/treatment Phase
Hip Fractures Other: PGDT based on noninvasive monitoring Device: System ClearSight® and Platform EV Clinic 1000® Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 568 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Perioperative Goal Directed Hemodynamic Therapy Based on Noninvasive Monitoring to Reduce Perioperative Complications in Patients With Hip Fracture
Actual Study Start Date : June 2015
Actual Primary Completion Date : February 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control group
Hemodynamic optimization according to the standards of perioperative monitoring of our center. In the intraoperative and immediate postoperative period hemodynamic monitoring will be done by controlling blood pressure, heart rate, oxygen saturation and diuresis.
Experimental: PGDT noninvasive monitoring group
PGDT based on noninvasive monitoring System ClearSight® and Platform EV Clinic 1000®
Other: PGDT based on noninvasive monitoring

Before entering the operating room, hemodynamic optimization start by optimizing preload with Fluid Challenge according to evidence-based PGDT protocols. Once stabilized the cardiovascular system after induction of anesthesia, hemodynamic optimization continue with Mini Fluid Challenge.

In the intra and postoperative period (4 hours), hemodynamic optimization is based on maintaining systolic blood pressure and stroke volume. In case of instability a Mini Fluid Challenge is administered to patients who respond to volume or a vasoactive drug according cardiac index for non-responders.

Other Name: Perioperative Goal-Directed Hemodynamic Therapy

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. We will also collect hourly diuresis and blood loss.




Primary Outcome Measures :
  1. Intraoperative hemodynamic instability [ Time Frame: Intraoperative period ]
    A value of systolic blood pressure less than 90 mmHg and/or the need for a bolus of vasoconstrictor.


Secondary Outcome Measures :
  1. Intraoperative complications [ Time Frame: Intraoperative period ]
    Cardiocirculatory, respiratory, neurological, renal, infectious and major bleeding

  2. Postoperative complications [ Time Frame: Patients will be followed for the duration of hospital stay, an expected median of 11 days ]
    Cardiocirculatory, respiratory, neurological, renal, infectious and major bleeding

  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 ]


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pathological fracture
  • High-impact trauma fracture
  • Anesthetic contraindication for surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02479321


Contacts
Contact: Juan Víctor Lorente Olazábal, MD 938742112 jlorente@althaia.cat
Contact: Anna Arnau Bartés, MSc 93 875 93 00 ext 3414 aarnau@althaia.cat

Locations
Spain
Althaia Xarxa Assistencial Universitària de Manresa Recruiting
Manresa, Barcelona, Spain, 08243
Contact: Juan Víctor Lorente Olazábal, MD    +34938742121    jlorente@althaia.cat   
Contact: Anna Arnau Bartés, MSc    +34938759300 ext 3414    aarnau@althaia.cat   
Sponsors and Collaborators
Althaia Xarxa Assistencial Universitària de Manresa
Investigators
Study Chair: Joan Bosch Sabater, MD PhD Althaia Xarxa Assistencial Universitària de Manresa
Study Chair: Francesca Reguant Corominas, MD PhD Althaia Xarxa Assistencial Universitària de Manresa

Responsible Party: Juan Víctor, Medical Doctor, Althaia Xarxa Assistencial Universitària de Manresa
ClinicalTrials.gov Identifier: NCT02479321     History of Changes
Other Study ID Numbers: CEIC 15/03
First Posted: June 24, 2015    Key Record Dates
Last Update Posted: June 29, 2018
Last Verified: June 2018

Keywords provided by Juan Víctor, Althaia Xarxa Assistencial Universitària de Manresa:
Perioperative Goal-Directed Hemodynamic Therapy
Fluid therapy
Aged
Perioperative complications
Survival

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries