Hip FracturesNCT02479321
Goal Directed Hemodynamic Therapy Based on Noninvasive Monitoring in Patients With Hip Fracture
A study testing GDT based on noninvasive monitoring and System ClearSight® and Platform EV Clinic 1000® in people with Hip Fractures, run by Juan-Víctor Lorente, MD, PhD at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- GDT based on noninvasive monitoring and System ClearSight® and Platform EV Clinic 1000®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 568 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2015to Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Hip fracture that require surgical treatment
- Agree to participate and sign informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
Althaia Xarxa Assistencial Universitària de Manresa
Manresa, Barcelona, 08243
About this study
Official title: Efficacy of Goal Directed Hemodynamic Therapy Based on Noninvasive Monitoring to Reduce Perioperative Complications 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.
- Conditions
- Hip Fractures
- Being tested
- GDT based on noninvasive monitoring, System ClearSight® and Platform EV Clinic 1000®
- Keywords
- Fluid therapy, Aged, Perioperative complications, Survival, Intraoperative Goal Directed Therapy
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GDT based on noninvasive monitoringOther
Also called Intraoperative Goal-Directed Hemodynamic Therapy
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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® Receives: Other: GDT based on noninvasive monitoring; Device: System ClearSight® and Platform EV Clinic 1000® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intraoperative period
Secondary outcomes (4)
Intraoperative arrhythmias
Electrocardiographic evidence of cardiac rhythm disturbance.
Measured: Intraoperative period
Postoperative complications
Major cardiovascular complications, minor cardiovascular complications, Respiratory, Renal, Infections, Surgical reintervention during hospital stay
Measured: Postoperative period
Hospital stay
Length of hospital stay (days)
Measured: Patients will be followed for the duration of hospital stay, an expected median of 11 days
Survival
Measured: One-year survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionFeb 2018
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 568 participants (actual)
Sponsor and investigators
- Lead sponsor
- Juan-Víctor Lorente, MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Juan-Víctor Lorente, MD, PhD, Althaia Xarxa Assistencial Universitària de Manresa
- Investigators
- Joan Bosch Sabater, MD PhD, Study chair, Althaia Xarxa Assistencial Universitària de ManresaFrancesca Reguant Corominas, MD PhD, Study chair, Althaia Xarxa Assistencial Universitària de Manresa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02479321
- Sponsor's protocol ID
- CEIC 15/03
- Status last verified
- Dec 2021
- First submitted
- 15 Jun 2015
- Last updated
- 28 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 35945605
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Goal Directed Hemodynamic Therapy Based on Noninvasive Monitoring to Reduce Perioperative Complications in Patients With Hip Fracture
- ClinicalTrials.gov ID
- NCT02479321
- Acronym / sponsor ID
- CEIC 15/03
- Conditions
- Hip Fractures
- Keywords
- Fluid therapy, Aged, Perioperative complications, Survival, Intraoperative Goal Directed Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 568 participants (actual)
- Lead sponsor
- Juan-Víctor Lorente, MD, PhDUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 24 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: GDT based on noninvasive monitoring, Device: System ClearSight® and Platform EV Clinic 1000®GDT based on noninvasive monitoring System ClearSight® and Platform EV Clinic 1000® |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Hip fracture that require surgical treatment
- Agree to participate and sign informed consent
Key exclusion criteria (6 listed)
- Pathological or traffic related fractures
- Anesthetic contraindication for surgery
- Refractures
- Contraindication for hemodynamic monitoring
- Physiocal less than 30 after 7 minutes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GDT based on noninvasive monitoringAlso: Intraoperative Goal-Directed Hemodynamic TherapyBefore 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 | GDT noninvasive monitoring group |
| 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. | Device | GDT noninvasive monitoring group |
Primary outcome
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.
4 secondary outcomes
Intraoperative arrhythmias
Time frame: Intraoperative period
Postoperative complications
Time frame: Postoperative period
Hospital stay
Time frame: Patients will be followed for the duration of hospital stay, an expected median of 11 days
Survival
Time frame: One-year survival
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2021.
- Derived from this study: PubMed 35945605Lorente 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joan Bosch Sabater, MD PhD study chair
Althaia Xarxa Assistencial Universitària de Manresa
Francesca Reguant Corominas, MD PhD study chair
Althaia Xarxa Assistencial Universitària de Manresa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GDT based on noninvasive monitoring and System ClearSight® and Platform EV Clinic 1000® in people with Hip Fractures, run by Juan-Víctor Lorente, MD, PhD at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients who developed intraoperative haemodynamic instability (time frame: Intraoperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02479321, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2021.