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
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- Intraoperative complications [ Time Frame: Intraoperative period ]Cardiocirculatory, respiratory, neurological, renal, infectious and major bleeding
- 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
- 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)
- Survival [ Time Frame: One-year survival ]
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
|Contact: Juan Víctor Lorente Olazábal, MDfirstname.lastname@example.org|
|Contact: Anna Arnau Bartés, MSc||93 875 93 00 ext email@example.com|
|Althaia Xarxa Assistencial Universitària de Manresa||Recruiting|
|Manresa, Barcelona, Spain, 08243|
|Contact: Juan Víctor Lorente Olazábal, MD +34938742121 firstname.lastname@example.org|
|Contact: Anna Arnau Bartés, MSc +34938759300 ext 3414 email@example.com|
|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|