Fracture of HipNCT03401138
Hemodynamic Monitoring and Resuscitation in Hip Fractures
An observational study of Fracture of Hip, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
Background: Fracture of the hip is a potentially fatal event in an elderly, frail, highly comorbid patient group suffering from dehydration and hypovolemia, and it carries a risk that equals major trauma in young patients in regard of physiological insult and severity, yet no preoperative resuscitation and transfusion… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Fracture of Hip
- What is being tested?
- Preoperative Stroke Volume(SV)-guided fluid optimization
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 14 Feb 2018to 28 Oct 2019
- Phase
- Observational
- 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
Study population: Patients presenting a primary acute HF within the study period will be screened for participation by the attending anesthesiologist at the post-anesthesia care unit. The study manager will verify the inclusion and exclusion criteria and inform patients (verbally and in writing) and confirm their agreement to participate by asking them to sign the informed consent document. Assessment of electronic patient records, monitoring and resuscitation treatment and recording of data will be by the study manager.
Who may be able to join
- Primary acute hip fracture
- Age grater than 65 years
- Written informed consent
Who cannot join
- Contraindications to epidural analgesia
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department af Anesthesia, Hvidovre Hospital
Hvidovre, Copenhagen, 2650
About this study
Official title: Preoperative Hemodynamic Monitoring and Resuscitation in Hip Fractures: a Prospective Observational Study
Background: Fracture of the hip is a potentially fatal event in an elderly, frail, highly comorbid patient group suffering from dehydration and hypovolemia, and it carries a risk that equals major trauma in young patients in regard of physiological insult and severity, yet no preoperative resuscitation and transfusion strategy is available. An important goal of hemodynamic monitoring and resuscitation is early detection of insufficient tissue perfusion and oxygenation. The peripheral perfusion index reflects changes in peripheral perfusion and blood volume and a decreased peripheral perfusion index predicts surgical complications and morbidity in acute surgical and septic shock patients. The research group hypothesize that elderly frail patients with a fracture of the hip suffer from hypovolemia and peripheral hypoperfusion of varying degrees and accordingly respond to controlled fluid resuscitation and that the non-invasive peripheral perfusion index will serve as an early predictor of a deteriorated circulation in reflection of stroke volume.
Methods: The main objective of this prospective observational study is to assess to what extend patients with fracture of the hip suffer from hypovolemia and respond to a fluid challenge. The secondary objectives are to evaluate correlation between the minimally-invasive measurements of stroke volume and blood volume and the non-invasive measurement of peripheral perfusion index and near-infrared spectroscopy, as well as prevalence of postoperative complications and mortality. Fifty consecutive patients over the age of 65 years, presenting with a hip fracture, treated in a multimodal fast-track regimen, will be included when written informed consent is available. All patients will receive epidural analgesia and preoperative stroke volume-guided hemodynamic optimization. Blood volume measurements are performed and all patients are monitored with peripheral perfusion index and near-infrared spectroscopy.
Discussion: This is likely the first study to address clinically applicable hemodynamic monitoring and resuscitation in patients with fracture of the hip where adequate resuscitation is easily missed. The study group aim to evaluate the feasibility of preoperative stroke volume-guided hemodynamic optimization in the context of minimally- and non-invasive monitoring of peripheral perfusion and blood volume measurements.
- Conditions
- Fracture of Hip
- Being tested
- Preoperative Stroke Volume(SV)-guided fluid optimization
- Keywords
- Peripheral perfusion, Blood Volume, Tissue Prefusion, Near-infrared spectroscopy, Hemodynamic monitoring, Hemodynamic optimization, Preoperative resuscitation
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative Stroke Volume(SV)-guided fluid optimizationOther
Also called Blood volume measurement, Monitoring of Peripheral Perfusion Index (PPI), Monitoring of Near-infrared Spectroscopy (NIRS)
Preoperative SV-guided hemodynamic optimization will be commenced with patients receiving 250ml fluid challenges over five minutes aiming to maximize SV. Maximal SV is defined as absence of a sustained rise in SV by at least 10% in response to a fluid challenge.
PPI will be obtained from the Masimo Radical 7 (Masimo, Irvine, CA, USA) and NIRS from Invos 5100C (Medtronic, Minneapolis, MN, USA).
BV measurements will use pulse dye densitometry (PDD) with Indocyanine Green (ICG). We will use the Dye Densitogram 3300 analyser Nihon Kohden (Tokyo, Japan) for registration of the spectrophotometrical absorption of ICG and calculation of BV.
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients presenting with preoperative hypovolemia/reduced BV before and after epidural anesthesia
Measured: Preoperatively
Proportion of patients with low/very low PPI (PII<1.4 and < 0.5) before and after epidural anesthesia
Measured: Preoperatively
Proportion of patients who respond to a 250 ml fluid challenge with sustained rise in SV by at least 10%
Measured: Preoperatively
Secondary outcomes (6)
Correlation between SV, PII and NIRS at normo- and hypovolemia states
Measured: Preoperatively
Correlation between PPI and standard microcirculatory variables including lactate, capillary refill time (CRT), and central vs. peripheral temperature
Measured: Preoperatively
Correlation between non-invasive Hemoglobin (Hb), BV and arterial Hb
Measured: Preoperatively
Proportion of mortality in patients responding to the fluid challenge vs. patients not responding
Measured: At 30 days and 1 year
Proportion of postoperative complications in patients responding to the fluid challenge vs. patients not responding
Measured: At 30 days and 1 year
Proportion of mortality in patients with high vs. low PPI and NIRS, including impact of BV
Measured: At 30 days and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start14 Feb 2018
- Primary completion28 Oct 2019
- Study completion28 Oct 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 Fracture of HipStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marianne Agerskov, Hvidovre University Hospital
- Investigators
- Nicolai Bang Foss, Clinical Professor, Study director, Department of Anesthesia, Hvidovre HospitalJakob Højlund, MD, Senior Hospital Physiscian, Study chair, Department of Anesthesia, Hvidovre HospitalHenrik Sørensen, MD, DMSc, Study chair, Abdominal Centre, Department of Anesthesia, RigshospitaletNiels Secher, Professor, DMSc, Study chair, Abdominal Centre, Department of Anesthesia, RigshospitaletMarianne Agerskov, MD, Research Fellow, Principal investigator, Department of Anesthesia, Hvidovre Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03401138
- Sponsor's protocol ID
- H- 17037633
- Status last verified
- Oct 2019
- First submitted
- 3 Jan 2018
- Last updated
- 30 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Agerskov M, Sorensen H, Hojlund J, Secher NH, Foss NB. Pre-operative haemodynamic monitoring and resuscitation in hip fracture patients: Protocol for a prospective observational study. Acta Anaesthesiol Scand. 2018 Oct;62(9):1314-1320. doi: 10.1111/aas.13163. Epub 2018 May 30.
PubMed 29851062
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Hemodynamic Monitoring and Resuscitation in Hip Fractures: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03401138
- Acronym / sponsor ID
- H- 17037633
- Conditions
- Fracture of Hip
- Keywords
- Peripheral perfusion, Blood Volume, Tissue Prefusion, Near-infrared spectroscopy, Hemodynamic monitoring, Hemodynamic optimization, Preoperative resuscitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- 14 Feb 2018 (actual)
- Primary completion
- 28 Oct 2019 (actual)
- Study completion
- 28 Oct 2019 (actual)
- First posted
- 17 Jan 2018 (actual)
- 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.
Background: Fracture of the hip is a potentially fatal event in an elderly, frail, highly comorbid patient group suffering from dehydration and hypovolemia, and it carries a risk that equals major trauma in young patients in regard of physiological insult and severity, yet no preoperative resuscitation and transfusion strategy is available. An important goal of hemodynamic monitoring and resuscitation is early detection of insufficient tissue perfusion and oxygenation. The peripheral perfusion index reflects changes in peripheral perfusion and blood volume and a decreased peripheral perfusion index predicts surgical complications and morbidity in acute surgical and septic shock patients. The research group hypothesize that elderly frail patients with a fracture of the hip suffer from hypovolemia and peripheral hypoperfusion of varying degrees and accordingly respond to controlled fluid resuscitation and that the non-invasive peripheral perfusion index will serve as an early predictor of a deteriorated circulation in reflection of stroke volume.
Methods: The main objective of this prospective observational study is to assess to what extend patients with fracture of the hip suffer from hypovolemia and respond to a fluid challenge. The secondary objectives are to evaluate correlation between the minimally-invasive measurements of stroke volume and blood volume and the non-invasive measurement of peripheral perfusion index and near-infrared spectroscopy, as well as prevalence of postoperative complications and mortality. Fifty consecutive patients over the age of 65 years, presenting with a hip fracture, treated in a multimodal fast-track regimen, will be included when written informed consent is available. All patients will receive epidural analgesia and preoperative stroke volume-guided hemodynamic optimization. Blood volume measurements are performed and all patients are monitored with peripheral perfusion index and near-infrared spectroscopy.
Discussion: This is likely the first study to address clinically applicable hemodynamic monitoring and resuscitation in patients with fracture of the hip where adequate resuscitation is easily missed. The study group aim to evaluate the feasibility of preoperative stroke volume-guided hemodynamic optimization in the context of minimally- and non-invasive monitoring of peripheral perfusion and blood volume measurements.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients presenting a primary acute HF within the study period will be screened for participation by the attending anesthesiologist at the post-anesthesia care unit. The study manager will verify the inclusion and exclusion criteria and inform patients (verbally and in writing) and confirm their agreement to participate by asking them to sign the informed consent document. Assessment of electronic patient records, monitoring and resuscitation treatment and recording of data will be by the study manager.
Key inclusion criteria (3 listed)
- Primary acute hip fracture
- Age grater than 65 years
- Written informed consent
Key exclusion criteria (1 listed)
- Contraindications to epidural analgesia
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 |
|---|---|---|
| Preoperative Stroke Volume(SV)-guided fluid optimizationAlso: Blood volume measurement, Monitoring of Peripheral Perfusion Index (PPI), Monitoring of Near-infrared Spectroscopy (NIRS)Preoperative SV-guided hemodynamic optimization will be commenced with patients receiving 250ml fluid challenges over five minutes aiming to maximize SV. Maximal SV is defined as absence of a sustained rise in SV by at least 10% in response to a fluid challenge. PPI will be obtained from the Masimo Radical 7 (Masimo, Irvine, CA, USA) and NIRS from Invos 5100C (Medtronic, Minneapolis, MN, USA). BV measurements will use pulse dye densitometry (PDD) with Indocyanine Green (ICG). We will use the Dye Densitogram 3300 analyser Nihon Kohden (Tokyo, Japan) for registration of the spectrophotometrical absorption of ICG and calculation of BV. | Other | – |
Primary outcome
Proportion of patients presenting with preoperative hypovolemia/reduced BV before and after epidural anesthesia
Time frame: Preoperatively
Proportion of patients with low/very low PPI (PII<1.4 and < 0.5) before and after epidural anesthesia
Time frame: Preoperatively
Proportion of patients who respond to a 250 ml fluid challenge with sustained rise in SV by at least 10%
Time frame: Preoperatively
6 secondary outcomes
Correlation between SV, PII and NIRS at normo- and hypovolemia states
Time frame: Preoperatively
Correlation between PPI and standard microcirculatory variables including lactate, capillary refill time (CRT), and central vs. peripheral temperature
Time frame: Preoperatively
Correlation between non-invasive Hemoglobin (Hb), BV and arterial Hb
Time frame: Preoperatively
Proportion of mortality in patients responding to the fluid challenge vs. patients not responding
Time frame: At 30 days and 1 year
Proportion of postoperative complications in patients responding to the fluid challenge vs. patients not responding
Time frame: At 30 days and 1 year
Proportion of mortality in patients with high vs. low PPI and NIRS, including impact of BV
Time frame: At 30 days and 1 year
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 30 Oct 2019.
- Derived from this study: PubMed 29851062Agerskov M, Sorensen H, Hojlund J, Secher NH, Foss NB. Pre-operative haemodynamic monitoring and resuscitation in hip fracture patients: Protocol for a prospective observational study. Acta Anaesthesiol Scand. 2018 Oct;62(9):1314-1320. doi: 10.1111/aas.13163. Epub 2018 May 30.
- Individual participant dataSharing planned: No
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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.
Nicolai Bang Foss, Clinical Professor study director
Department of Anesthesia, Hvidovre Hospital
Jakob Højlund, MD, Senior Hospital Physiscian study chair
Department of Anesthesia, Hvidovre Hospital
Henrik Sørensen, MD, DMSc study chair
Abdominal Centre, Department of Anesthesia, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fracture of Hip, run by Hvidovre University Hospital at 1 site in Denmark.
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 3 inclusion and 1 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 30 Oct 2019. 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 Denmark. 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?
Proportion of patients presenting with preoperative hypovolemia/reduced BV before and after epidural anesthesia (time frame: Preoperatively). The study lists 3 primary outcomes in all. 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 NCT03401138, 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 30 Oct 2019.