Femoral Neck FracturesNCT05154435
the Effects of Perioperative Goal Directed and Conventional Fluid Management on the IVC Collapsibility Index
A study testing mostcare hemodynamic monitor in people with Femoral Neck Fractures, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The investigators aimed to compare the effects of targeted fluid management and traditional fluid management on the inferior vena cava collapsibility index in participants who will undergo proximal femoral surgery. Read more about this study
- Who is it for?
- Ages 65 to 101 yearsHealthy volunteers can take part
- Conditions the study is for
- Femoral Neck Fractures
- What is being tested?
- mostcare hemodynamic monitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2021to 15 Oct 2021
- 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 to 101 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 65 years and older
- 1-3 ASA anesthesia risk
- Planned to undergo proximal femoral surgery due to intertochanteric fracture
Who cannot join
- cardiac arrhythmia,
- chronic renal failure and those on dialysis,
- heart failure,
- aortic insufficiency,
- active lower/upper respiratory tract infections,
- inferior vena cava cannot be clearly visualized by USG, BMI>35, Patients in need of postoperative intensive care or ASA4, Patients with advanced obstructive or restrictive respiratory diseases, Patients under 65 years of age.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Fatih Sultan Mehmet Research and Training Hospital
Istanbul, 34752
About this study
Official title: Comparison of the Effects of Perioperative Targeted and Traditional Fluid Management on Inferior Vena Cava Collapsibility Index and Postoperative Complications in Geriatric Patients Undergoing Proximal Femoral Surgery
The investigators aimed to compare the effects of targeted fluid management and traditional fluid management on the inferior vena cava collapsibility index in participants who will undergo proximal femoral surgery. In addition, the amount of fluid given, blood products, the number of perioperative hypotensive events, perioperative hemodynamics, perioperative and postoperative blood gas analysis, perioperative urine output and bleeding amount, postoperative complications (cardiac, respiratory, renal, etc.), postoperative 30-day mortality, nausea and vomiting score, It was aimed to evaluate and compare the postoperative hospitalization day as secondary.
Read the detailed description
Hip fracture surgeries have become one of the most frequently performed surgeries with the increase in the aging population in recent years. Perioperative fluid management of geriatric patients who become prone to dehydration due to malnutrition, decreased functional capacity, impaired cognitive functions after hip fracture development; It is important in terms of reducing complications in the postoperative period and perioperative hemodynamics.
The traditional approach to perioperative fluid administration is the fluid deficit for the fasting period with the '4-2-1' rule (4ml/kg/hr for the first 10 kg, 2ml/kg/hr for the second 10 kg, 1ml/kg/hr for each subsequent kg). ) calculation. The fluid and blood losses in the surgical area and the fluid deficit are estimated and replaced. In order to replace the volume deficit caused by blood loss, crystalloid is used 3 times the amount of bleeding, taking into account the crystalloid movement into the extravascular compartment. Static parameters such as blood pressure, heart rate, and urine volume, which are followed in fluid management with the traditional approach, support the estimation of intravascular volume.
Maintaining intravascular euvolemia throughout the perioperative period is ideal. Both hypovolemia and hypervolemia are associated with increased postoperative morbidity. While vasoconstriction due to hypovolemia, decreased oxygen delivery, decreased tissue perfusion and dysfunction in peripheral organs can be observed; Tissue edema due to hypervolemia, impaired tissue perfusion, local inflammation, delayed wound healing, wound infection and anastomotic leaks can be seen. There is no clear consensus on how to perform optimal fluid management in this population, which has many comorbidities and is at high risk for postoperative complications.
The search for an optimal fluid regimen to avoid excessive intravascular volume overload and maximize tissue perfusion has brought individualized targeted fluid replacement therapies with the help of developing technology. In the targeted therapy (HYT) approach, basic physiological variables related to cardiac output or global O2 distribution are measured with the aim of improving tissue perfusion and clinical outcome. Replacement by crystalloid, colloid or blood products is adjusted according to the dynamic process according to the measured physiological variables. Methods such as pulmonary artery catheter, esophageal doppler, central venous pressure measurement, echocardiography, lactate, central venous saturation, thoracic bioimpedance and arterial waveform analysis can be used to determine physiological targets.
Arterial waveform analysis provides estimation of cardiac output based on continuous analysis of the waveform, a complex physiological signal determined by the interaction of left ventricular stroke volume, systemic vascular resistance, and vascular compliance. Arterial waveform analysis stands out because it can measure continuous cardiac output and does not require a central venous catheter. There are invasive, minimally invasive and non-invasive waveform monitoring systems.
One of the methods used in the evaluation of intravascular volume status is the evaluation of the diameter of the inferior vena cava (IVC) and its collapsibility, which changes with respiration. It can be done at the bedside, it is a fast and noninvasive method.
Inferior vena cava collapsibility index (cIVC) can be used as an indicator of fluid response and a guide in fluid management in critically ill breathing spontaneously.
Several meta-analyses have reported that individualized targeted perioperative fluid managements reduce organ-specific complications in patients undergoing major surgery. In a study, it was stated that targeted fluid therapy in patients with proximal femur fractures decreased the total amount of fluid administered and could reduce postoperative complications.
Although the necessity of providing adequate intravascular volume in perioperative fluid management is obvious, an optimal fluid management guideline has not been established in geriatric and emergency cases with high mortality. The investigators aimed to compare the cIVC measurements and perioperatively administered fluid volumes of the patients who the investigators performed fluid management with the arterial waveform analysis method, which measures the minimally invasive continuous cardiac output, and the patients with whom the investigators had fluid management with traditional methods, and to examine the postoperative effects.
- Conditions
- Femoral Neck Fractures
- Being tested
- mostcare hemodynamic monitor
- Keywords
- intraoperative care, hemodynamic monitoring, fluid therapy
- Medical subject headings
- Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mostcare hemodynamic monitorDrug
Also called minimally invasive cardiac output monitors
mostcare hemodynamic monitoring integrated into the radial artery catheter. According to the data obtained, intraoperative fluid management was arranged with certain algorithms.
| Study group | Role | What they receive |
|---|---|---|
| Grup HYT | Active comparator | The group (GRUP HYT) to be treated with targeted fluid therapy will be monitored with a Mostcaretm (Vygon, VytechHealth, Padova, Italy) pulse contour hemodynamic monitor after arterial cannulation. Cardiacindex (CI), stroke volume variance (SVV), pulse pressure variance (PPV), systemic vascular resistance (SVR), systemic vascular resistance index (SVRI), oxygen delivery (Do2), arterial elastance (Ea) measurements and mean arterial pressure Every 5 minutes to be followed, fluid therapy will be planned in accordance with our algorithm. Receives: Drug: mostcare hemodynamic monitor |
| Grup KON | No intervention | Fluid deficit due to fasting time will be calculated in accordance with the 4-2-1 rule for patients in Group KON. half of the calculated fluid volume in the first hour; the remaining half will be given at the 2nd and 3rd Hours. (4ml/kg/hr for the first 10 kilograms, 2ml/kg/hr for the second 10 kg, 1ml/kg/hr for each subsequent kilogram). Maintenance fluid will be considered as a medium-sized surgical trauma and will be given at 4 ml/kg/hr. Hemorrhages will be replaced with 3 times the blood loss with balanced crystalloid or 1 times HES. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inferior vena cava (IVC) collapsibility index
inspiratory IVC diameter and expiratory IVC diameter will measured and collapsibility index will be calculated
Measured: one month
Secondary outcomes (4)
amount of given crystalloid and colloid volume
Total delivered crystalloid, colloid, urine output, and bleeding volume (ml) will be recorded during the intraoperative period.
Measured: one month
arterial blood gas analysis
preoperative and postoperative hemoglobin, hematocrit, sodium, potassium, lactate, base excess, bicarbonate values will be compared
Measured: one month
postoperative complications (yes or no)
patients before discharge, hemorrhagic, cerebral, infective complications, etc. will be questioned in terms of the presence or absence of complications.
Measured: one month
postoperative 30-day mortality (yes or no)
Postoperative 30-day mortality patients will be called by phone and questioned.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start1 Jul 2021
- Primary completion1 Oct 2021
- Study completion15 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Neck 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of 60 patients over the age of 65, who were scheduled for proximal femoral surgery due to intertochanteric fracture, and operated with ASA1-3 risk will be included in the study. The patients will be randomized into two groups as Group K (n=30) and Group H (n=30) by the closed envelope method and the patients will not know their groups.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- arzu yıldırım ar, ass prof, Principal investigator, Fatih Sultan Mehmet Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05154435
- Sponsor's protocol ID
- FSMTRH1
- Status last verified
- Nov 2021
- First submitted
- 16 Nov 2021
- Last updated
- 13 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Perioperative Targeted and Traditional Fluid Management on Inferior Vena Cava Collapsibility Index and Postoperative Complications in Geriatric Patients Undergoing Proximal Femoral Surgery
- ClinicalTrials.gov ID
- NCT05154435
- Acronym / sponsor ID
- FSMTRH1
- Conditions
- Femoral Neck Fractures
- Keywords
- intraoperative care, hemodynamic monitoring, fluid therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 15 Oct 2021 (actual)
- First posted
- 13 Dec 2021 (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.
The investigators aimed to compare the effects of targeted fluid management and traditional fluid management on the inferior vena cava collapsibility index in participants who will undergo proximal femoral surgery. In addition, the amount of fluid given, blood products, the number of perioperative hypotensive events, perioperative hemodynamics, perioperative and postoperative blood gas analysis, perioperative urine output and bleeding amount, postoperative complications (cardiac, respiratory, renal, etc.), postoperative 30-day mortality, nausea and vomiting score, It was aimed to evaluate and compare the postoperative hospitalization day as secondary.
Detailed description
Hip fracture surgeries have become one of the most frequently performed surgeries with the increase in the aging population in recent years. Perioperative fluid management of geriatric patients who become prone to dehydration due to malnutrition, decreased functional capacity, impaired cognitive functions after hip fracture development; It is important in terms of reducing complications in the postoperative period and perioperative hemodynamics.
The traditional approach to perioperative fluid administration is the fluid deficit for the fasting period with the '4-2-1' rule (4ml/kg/hr for the first 10 kg, 2ml/kg/hr for the second 10 kg, 1ml/kg/hr for each subsequent kg). ) calculation. The fluid and blood losses in the surgical area and the fluid deficit are estimated and replaced. In order to replace the volume deficit caused by blood loss, crystalloid is used 3 times the amount of bleeding, taking into account the crystalloid movement into the extravascular compartment. Static parameters such as blood pressure, heart rate, and urine volume, which are followed in fluid management with the traditional approach, support the estimation of intravascular volume.
Maintaining intravascular euvolemia throughout the perioperative period is ideal. Both hypovolemia and hypervolemia are associated with increased postoperative morbidity. While vasoconstriction due to hypovolemia, decreased oxygen delivery, decreased tissue perfusion and dysfunction in peripheral organs can be observed; Tissue edema due to hypervolemia, impaired tissue perfusion, local inflammation, delayed wound healing, wound infection and anastomotic leaks can be seen. There is no clear consensus on how to perform optimal fluid management in this population, which has many comorbidities and is at high risk for postoperative complications.
The search for an optimal fluid regimen to avoid excessive intravascular volume overload and maximize tissue perfusion has brought individualized targeted fluid replacement therapies with the help of developing technology. In the targeted therapy (HYT) approach, basic physiological variables related to cardiac output or global O2 distribution are measured with the aim of improving tissue perfusion and clinical outcome. Replacement by crystalloid, colloid or blood products is adjusted according to the dynamic process according to the measured physiological variables. Methods such as pulmonary artery catheter, esophageal doppler, central venous pressure measurement, echocardiography, lactate, central venous saturation, thoracic bioimpedance and arterial waveform analysis can be used to determine physiological targets.
Arterial waveform analysis provides estimation of cardiac output based on continuous analysis of the waveform, a complex physiological signal determined by the interaction of left ventricular stroke volume, systemic vascular resistance, and vascular compliance. Arterial waveform analysis stands out because it can measure continuous cardiac output and does not require a central venous catheter. There are invasive, minimally invasive and non-invasive waveform monitoring systems.
One of the methods used in the evaluation of intravascular volume status is the evaluation of the diameter of the inferior vena cava (IVC) and its collapsibility, which changes with respiration. It can be done at the bedside, it is a fast and noninvasive method.
Inferior vena cava collapsibility index (cIVC) can be used as an indicator of fluid response and a guide in fluid management in critically ill breathing spontaneously.
Several meta-analyses have reported that individualized targeted perioperative fluid managements reduce organ-specific complications in patients undergoing major surgery. In a study, it was stated that targeted fluid therapy in patients with proximal femur fractures decreased the total amount of fluid administered and could reduce postoperative complications.
Although the necessity of providing adequate intravascular volume in perioperative fluid management is obvious, an optimal fluid management guideline has not been established in geriatric and emergency cases with high mortality. The investigators aimed to compare the cIVC measurements and perioperatively administered fluid volumes of the patients who the investigators performed fluid management with the arterial waveform analysis method, which measures the minimally invasive continuous cardiac output, and the patients with whom the investigators had fluid management with traditional methods, and to examine the postoperative effects.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- A total of 60 patients over the age of 65, who were scheduled for proximal femoral surgery due to intertochanteric fracture, and operated with ASA1-3 risk will be included in the study. The patients will be randomized into two groups as Group K (n=30) and Group H (n=30) by the closed envelope method and the patients will not know their groups.
| Arm | Type | Receives |
|---|---|---|
| Grup HYT | Active comparator | Drug: mostcare hemodynamic monitorThe group (GRUP HYT) to be treated with targeted fluid therapy will be monitored with a Mostcaretm (Vygon, VytechHealth, Padova, Italy) pulse contour hemodynamic monitor after arterial cannulation. Cardiacindex (CI), stroke volume variance (SVV), pulse pressure variance (PPV), systemic vascular resistance (SVR), systemic vascular resistance index (SVRI), oxygen delivery (Do2), arterial elastance (Ea) measurements and mean arterial pressure Every 5 minutes to be followed, fluid therapy will be planned in accordance with our algorithm. |
| Grup KON | No intervention | –Fluid deficit due to fasting time will be calculated in accordance with the 4-2-1 rule for patients in Group KON. half of the calculated fluid volume in the first hour; the remaining half will be given at the 2nd and 3rd Hours. (4ml/kg/hr for the first 10 kilograms, 2ml/kg/hr for the second 10 kg, 1ml/kg/hr for each subsequent kilogram). Maintenance fluid will be considered as a medium-sized surgical trauma and will be given at 4 ml/kg/hr. Hemorrhages will be replaced with 3 times the blood loss with balanced crystalloid or 1 times HES. |
Who may qualify
- Ages
- 65 to 101 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 65 years and older
- 1-3 ASA anesthesia risk
- Planned to undergo proximal femoral surgery due to intertochanteric fracture
Key exclusion criteria (6 listed)
- cardiac arrhythmia,
- chronic renal failure and those on dialysis,
- heart failure,
- aortic insufficiency,
- active lower/upper respiratory tract infections,
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 |
|---|---|---|
| mostcare hemodynamic monitorAlso: minimally invasive cardiac output monitorsmostcare hemodynamic monitoring integrated into the radial artery catheter. According to the data obtained, intraoperative fluid management was arranged with certain algorithms. | Drug | Grup HYT |
Primary outcome
Inferior vena cava (IVC) collapsibility index
Time frame: one month
inspiratory IVC diameter and expiratory IVC diameter will measured and collapsibility index will be calculated
4 secondary outcomes
amount of given crystalloid and colloid volume
Time frame: one month
arterial blood gas analysis
Time frame: one month
postoperative complications (yes or no)
Time frame: one month
postoperative 30-day mortality (yes or no)
Time frame: one month
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 13 Dec 2021.
- Individual participant dataSharing planned: Yes
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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.
arzu yıldırım ar, ass prof principal investigator
Fatih Sultan Mehmet Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mostcare hemodynamic monitor in people with Femoral Neck Fractures, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
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 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 13 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 Turkey (Türkiye). 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?
Inferior vena cava (IVC) collapsibility index (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Dec 2021.