Fluid TherapyNCT06206434
Point of Care Ultrasound and Co-loading in Patients With Spinal-induced Hypotension and Cardiac Diseases
An observational study of Fluid Therapy and Dehydration, run by Attikon Hospital at 1 site in Greece.
Trial summary
In elderly patients with cardiac diseases, changes in cardiovascular physiology diminish cardiovascular reserve and predispose to significant hemodynamic instability after spinal anesthesia; hence, such patients could be at risk of postoperative complications. Read more about this study
- Who is it for?
- Ages 70 to 100 years
- Conditions the study is for
- Fluid Therapy, Dehydration
- What is being tested?
- Point of care ultrasonography
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- 2 Jan 2024to 10 Jun 2026
- 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 70 to 100 years
- All sexes
- Older adult
Study population: Study participants; patients who were American Heart Association/American College of Cardiology (AHA/ACC) stage B or C whose cardiac disease status was compensated.
Who may be able to join
- All the included patients have BUN-to-creatinne ratio>20
- LV-EF between 35% and 50%
- Normal RV function indices [tricuspid annular plane systolic excursion (TAPSE) index > 16 and tricuspid annular systolic velocity (TASV) > 10 cm/sec and fractional area change (FAC) > 35%)]
Who cannot join
- Poor acoustic windows,
- Tthose who were included during the initial screening, but they finally found with pulmonary hypertension (peak tricuspid velocity > 3.4 m/sec), tricuspid/mitral/pulmonary valve regurgitation grade 3 or 4, severe aortic/mitral valve stenosis, and severe mitral annulus calcification on the preoperative echocardiogram.
- All patients with maximum cephalad dermatomal extension of the spinal sensory block below T12 or arterial hypotension related to overt intraoperative bleeding (>150 cc) are excluded.
- Intraoperrative hypotension due to bleeding and cement placement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Point of Care Ultrasound and Fluids Co-loading for the Prevention of Spinal-induced Hypotension in Dehydrated Elderly Patients and Cardiac Diseases
In elderly patients with cardiac diseases, changes in cardiovascular physiology diminish cardiovascular reserve and predispose to significant hemodynamic instability after spinal anesthesia; hence, such patients could be at risk of postoperative complications. Additionally, point of care ultrasound (POCUS) and transthoracic echocardiography (TTE) are used in clinical practice to evaluate cardiovascular hemodynamics. Inferior vena cava (IVC) and its collapsibility index (CI) have been used in clinical practice for the prediction of post-spinal hypotension. Specifically, the dIVCmax-to-IVCCI ratio < 48 showed high diagnostic performance among other indices in the prediction of post spinal hypotension in elderly patients with cardiac diseases undergoing proximal fracture repair. Elderly patients also experience high likelihood of dehydration.
According to the above findings, the investigators hypothesized that fluid co-loading immediately after spinal anesthesia can lower the incidence of spinal-induced hypotension in dehydrated patients. . For this reason, it is prospectively evaluated echocardiographic indices of the LV and the right ventricle (RV), as well as of the IVC prior to spinal anesthesia in elderly patients with proximal femur fractures who had low LV-EF and increased ratio of BUN-to-creatinine.
Read the detailed description
Elderly dehydrated patients (age>70 years) with proximal femur fracture scheduled for orthopedic surgical repair under spinal anesthesia were recruited. Patients' medical history, physical examination, electrocardiogram (ECG), and X-ray evaluation were performed during the preoperative assessment and supplemented by specific exams (e.g., troponin, pro-BNP levels, coronary angiography, myocardial perfusion scintigraphy, echocardiographic examination, or stress tests) as per consultant cardiologists' recommendations. Informed consent was obtained from the patients or their surrogates.
Based on cardiology consultation, the initial patient screening was used to identify those patients who were American Heart Association/American College of Cardiology (AHA/ACC) stage B or C whose cardiac disease status was compensated. Patients with tachycardia (heart rate > 100 beats/min), atrial fibrillation or left bundle branch block on ECG and those who diagnosed with moderate to severe or severe tricuspid or mitral valve regurgitation, severe aortic or mitral stenosis, severe pulmonary hypertension, right heart failure were not recruited. Patients who fulfilled the above criteria were scheduled for TTE examination prior to spinal anesthesia.
Baseline blood pressure measurements. In all the participants, the cardiovascular medication except for beta blockers was not given the day of surgery. Medications with standardized dose time once a day (e.g. angiotensin converting enzyme inhibitor) were discontinued 24 hours before surgery. Upon arrival in the operating room (preparation area), standard non-invasive monitoring (continuous ECG, non-invasive blood pressure measurements every three minutes and SPO2) was applied. Prior to placement of 20/18G intravenous and indwelling radial artery catheters, three consecutive MAP measurements were recorded, and their average was used as reference value.
Preoperative echocardiographic examination. After baseline MAP measurements and prior to spinal anesthesia induction, a complete TTE examination was performed which included the following views: parasternal long (LAX) and short axis (SAX), apical 4-chamber (4CH), including also the "RV-focused view", apical 2-chamber (2CH), apical 3-chamber (3CH) and subcostal IVC (SUB-IVC). All data were saved for off-line analysis. The physicians who analyzed the data were all competent at TTE. The LV-EF was estimated by the Simpson's method of discs by performing measurements of LV volumes in the 2CH and 4CH views. In suboptimal images, ultrasound contrast agents were used for the improvement of endocardial border definition. (SonoVue: Bracco, Milan, Italy and Optison: GE, Helthcare, USA).
To assess the function of the right ventricle (RV), the "RV-focused view" and the SUB-IVC views were acquired. The FAC, (2-dimentional surrogate for RV-EF) was calculated by the following formula: 100 × (RV-Area end-diastolic - RV-Area end-systolic) / RV-Area end-diastolic). Tricuspid regurgitation grading and velocity were assessed according to pertinent guidelines. LV filling pressures were estimated by the E/Em ratio (E=peak velocity of mitral flow in early diastole, Em=the average of peak velocities in early diastole of lateral and septal mitral annulus). Stroke volume (SV) and subsequent stroke volume index (SVI=SV/m2) of the LV were assessed using automated measurements of LV volumes, according to the formula SV = EDV-ESV, where EDV=end diastolic LV volume, and ESV=end systolic LV volume. From these data, we derived values for the assessment of cardiac output (CO) =SV x HR, and SVR =MAP x 80/CO, (MAP=mean arterial blood pressure, HR=heart rate). The IVC measurements included the IVC maximum diameter at the end of expiration (dIVCmax), the IVCCI during spontaneous, quiet, breathing [(IVC maximal diameter - IVC minimal diameter)/IVC maximal diameter], and the ratio of dIVCmax-to-IVCCI. All data were saved and stored digitally for off-line, postoperative analysis. All measurements were repeated twice (by a physician who were unaware of patients' hemodynamic status), and their arithmetical mean was taken for the analysis.
Spinal anesthesia protocol. As per departmental fasting guidelines, all patients were allowed to receive clear liquids and solid food until 2 and 8 hours before induction to spinal anesthesia, respectively. No pre-spinal anesthesia fluid load was given.
Ultrasound-guided fascia iliaca or supra-inguinal fascia iliaca nerve blocks were performed before spinal anesthesia to prevent patients' pain during lateral position placement. Ten to 20 mg of propofol were administered prior to nerve blocks. Additional sedation/analgesics (e.g propofol or remifentanil infusion) were not administered during the operation.
Spinal anesthesia was introduced with a single intrathecal injection of ropivacaine (0.75% solution) ranging between 12 to 18 mg (average dose 15 mg) depending on patients' age, frailty, and BMI, using a 22- or 25-gauge needle. The intrathecal injection was performed in inter-spaces L2-L3, L3-L4 or L4-L5. After subarachnoid injections, all patients immediately returned to supine position except for those with hip hemi-arthroplasty. Spinal anesthesia was followed by a continuous intravenous infusion of 1.5 ml/kg/h of Lactate Ringer's solution. Sensory block was assessed every 10 minutes after injection (pinprick test) until the end of surgery. The maximum cephalad dermatomal extent of the sensory block was measured. Spinal anesthesia was followed by a bolus 8 mgr/kg and a continuous intravenous infusion of 1.5 ml/kg/h of Lactate Ringer's solution.
Intraoperative blood pressure measurements and patients' follow up. After spinal anesthesia induction, continuous, invasive blood pressure measurements were taken and patients with MAP ≤ 65 mmHg, or with a reduction ≥ 25% of baseline pre-operative values, were considered hypotensive (time interval of low MAP: 30 seconds, assessment period of low MAP: from spinal anesthesia induction to the end of surgery). Once the patients experienced hypotension (fulfilling the above criteria) the patients were treated according to the attending's anesthesiologist clinical judgment.
The length of stay (LOS) in the PACU was also estimated and defined as the time from the patients' admission to the time of their discharge from the PACU. Patients who were hemodynamically stable during the intraoperative period, but experienced hypotension in the PACU, were not considered in the statistical analysis.
- Conditions
- Fluid Therapy, Dehydration
- Being tested
- Point of care ultrasonography
- Medical subject headings
- Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point of care ultrasonographyDiagnostic test
Also called Fluid-crystaloid co-loading immediately after spinal anesthesia
Transthoracic echocardiogrpahy followed spinal anesthesia and 5 ml/kg Ringers lactate fluid co-loading
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of hypotension events after spinal anesthesia in patients with crystaloids co-loading guided by transthoracic echocardiogrpahy
Patients with Mean arterial pressure (MAP) ≤ 65 mmHg, or with a reduction ≥ 25% of baseline pre-operative values are considered hypotensive
Measured: Thirty seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start2 Jan 2024
- Primary completion1 Jun 2026
- Study completion10 Jun 2026
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 Fluid TherapyStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Attikon Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, THEODOSIOS SARANTEAS, Attikon Hospital
- Investigators
- Theodosios Saranteas, MD, PhD, Principal investigator, University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06206434
- Sponsor's protocol ID
- 811
- Status last verified
- Jun 2026
- First submitted
- 26 Dec 2023
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moschovaki N, Saranteas T, Spiliotaki E, Giannoulis D, Anagnostopoulos D, Talliou C, Milionis O, Briassoulis P, Katogiannis K, Papadimos T. Point of care transthoracic echocardiography for the prediction of post - spinal anesthesia hypotension in elderly patients with cardiac diseases and left ventricular dysfunction : Inferior vena cava and post-spinal anesthesia hypotension in elderly patients. J Clin Monit Comput. 2023 Oct;37(5):1207-1218. doi: 10.1007/s10877-023-00981-y. Epub 2023 Feb 21.
PubMed 36805418
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point of Care Ultrasound and Fluids Co-loading for the Prevention of Spinal-induced Hypotension in Dehydrated Elderly Patients and Cardiac Diseases
- ClinicalTrials.gov ID
- NCT06206434
- Acronym / sponsor ID
- 811
- Conditions
- Fluid Therapy, Dehydration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Attikon HospitalUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 10 Jun 2026 (actual)
- First posted
- 16 Jan 2024 (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.
In elderly patients with cardiac diseases, changes in cardiovascular physiology diminish cardiovascular reserve and predispose to significant hemodynamic instability after spinal anesthesia; hence, such patients could be at risk of postoperative complications. Additionally, point of care ultrasound (POCUS) and transthoracic echocardiography (TTE) are used in clinical practice to evaluate cardiovascular hemodynamics. Inferior vena cava (IVC) and its collapsibility index (CI) have been used in clinical practice for the prediction of post-spinal hypotension. Specifically, the dIVCmax-to-IVCCI ratio < 48 showed high diagnostic performance among other indices in the prediction of post spinal hypotension in elderly patients with cardiac diseases undergoing proximal fracture repair. Elderly patients also experience high likelihood of dehydration.
According to the above findings, the investigators hypothesized that fluid co-loading immediately after spinal anesthesia can lower the incidence of spinal-induced hypotension in dehydrated patients. . For this reason, it is prospectively evaluated echocardiographic indices of the LV and the right ventricle (RV), as well as of the IVC prior to spinal anesthesia in elderly patients with proximal femur fractures who had low LV-EF and increased ratio of BUN-to-creatinine.
Detailed description
Elderly dehydrated patients (age>70 years) with proximal femur fracture scheduled for orthopedic surgical repair under spinal anesthesia were recruited. Patients' medical history, physical examination, electrocardiogram (ECG), and X-ray evaluation were performed during the preoperative assessment and supplemented by specific exams (e.g., troponin, pro-BNP levels, coronary angiography, myocardial perfusion scintigraphy, echocardiographic examination, or stress tests) as per consultant cardiologists' recommendations. Informed consent was obtained from the patients or their surrogates.
Based on cardiology consultation, the initial patient screening was used to identify those patients who were American Heart Association/American College of Cardiology (AHA/ACC) stage B or C whose cardiac disease status was compensated. Patients with tachycardia (heart rate > 100 beats/min), atrial fibrillation or left bundle branch block on ECG and those who diagnosed with moderate to severe or severe tricuspid or mitral valve regurgitation, severe aortic or mitral stenosis, severe pulmonary hypertension, right heart failure were not recruited. Patients who fulfilled the above criteria were scheduled for TTE examination prior to spinal anesthesia.
Baseline blood pressure measurements. In all the participants, the cardiovascular medication except for beta blockers was not given the day of surgery. Medications with standardized dose time once a day (e.g. angiotensin converting enzyme inhibitor) were discontinued 24 hours before surgery. Upon arrival in the operating room (preparation area), standard non-invasive monitoring (continuous ECG, non-invasive blood pressure measurements every three minutes and SPO2) was applied. Prior to placement of 20/18G intravenous and indwelling radial artery catheters, three consecutive MAP measurements were recorded, and their average was used as reference value.
Preoperative echocardiographic examination. After baseline MAP measurements and prior to spinal anesthesia induction, a complete TTE examination was performed which included the following views: parasternal long (LAX) and short axis (SAX), apical 4-chamber (4CH), including also the "RV-focused view", apical 2-chamber (2CH), apical 3-chamber (3CH) and subcostal IVC (SUB-IVC). All data were saved for off-line analysis. The physicians who analyzed the data were all competent at TTE. The LV-EF was estimated by the Simpson's method of discs by performing measurements of LV volumes in the 2CH and 4CH views. In suboptimal images, ultrasound contrast agents were used for the improvement of endocardial border definition. (SonoVue: Bracco, Milan, Italy and Optison: GE, Helthcare, USA).
To assess the function of the right ventricle (RV), the "RV-focused view" and the SUB-IVC views were acquired. The FAC, (2-dimentional surrogate for RV-EF) was calculated by the following formula: 100 × (RV-Area end-diastolic - RV-Area end-systolic) / RV-Area end-diastolic). Tricuspid regurgitation grading and velocity were assessed according to pertinent guidelines. LV filling pressures were estimated by the E/Em ratio (E=peak velocity of mitral flow in early diastole, Em=the average of peak velocities in early diastole of lateral and septal mitral annulus). Stroke volume (SV) and subsequent stroke volume index (SVI=SV/m2) of the LV were assessed using automated measurements of LV volumes, according to the formula SV = EDV-ESV, where EDV=end diastolic LV volume, and ESV=end systolic LV volume. From these data, we derived values for the assessment of cardiac output (CO) =SV x HR, and SVR =MAP x 80/CO, (MAP=mean arterial blood pressure, HR=heart rate). The IVC measurements included the IVC maximum diameter at the end of expiration (dIVCmax), the IVCCI during spontaneous, quiet, breathing [(IVC maximal diameter - IVC minimal diameter)/IVC maximal diameter], and the ratio of dIVCmax-to-IVCCI. All data were saved and stored digitally for off-line, postoperative analysis. All measurements were repeated twice (by a physician who were unaware of patients' hemodynamic status), and their arithmetical mean was taken for the analysis.
Spinal anesthesia protocol. As per departmental fasting guidelines, all patients were allowed to receive clear liquids and solid food until 2 and 8 hours before induction to spinal anesthesia, respectively. No pre-spinal anesthesia fluid load was given.
Ultrasound-guided fascia iliaca or supra-inguinal fascia iliaca nerve blocks were performed before spinal anesthesia to prevent patients' pain during lateral position placement. Ten to 20 mg of propofol were administered prior to nerve blocks. Additional sedation/analgesics (e.g propofol or remifentanil infusion) were not administered during the operation.
Spinal anesthesia was introduced with a single intrathecal injection of ropivacaine (0.75% solution) ranging between 12 to 18 mg (average dose 15 mg) depending on patients' age, frailty, and BMI, using a 22- or 25-gauge needle. The intrathecal injection was performed in inter-spaces L2-L3, L3-L4 or L4-L5. After subarachnoid injections, all patients immediately returned to supine position except for those with hip hemi-arthroplasty. Spinal anesthesia was followed by a continuous intravenous infusion of 1.5 ml/kg/h of Lactate Ringer's solution. Sensory block was assessed every 10 minutes after injection (pinprick test) until the end of surgery. The maximum cephalad dermatomal extent of the sensory block was measured. Spinal anesthesia was followed by a bolus 8 mgr/kg and a continuous intravenous infusion of 1.5 ml/kg/h of Lactate Ringer's solution.
Intraoperative blood pressure measurements and patients' follow up. After spinal anesthesia induction, continuous, invasive blood pressure measurements were taken and patients with MAP ≤ 65 mmHg, or with a reduction ≥ 25% of baseline pre-operative values, were considered hypotensive (time interval of low MAP: 30 seconds, assessment period of low MAP: from spinal anesthesia induction to the end of surgery). Once the patients experienced hypotension (fulfilling the above criteria) the patients were treated according to the attending's anesthesiologist clinical judgment.
The length of stay (LOS) in the PACU was also estimated and defined as the time from the patients' admission to the time of their discharge from the PACU. Patients who were hemodynamically stable during the intraoperative period, but experienced hypotension in the PACU, were not considered in the statistical analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 70 to 100 years
- Sex
- All
- Age groups
- Older adult
- Study population
- Study participants; patients who were American Heart Association/American College of Cardiology (AHA/ACC) stage B or C whose cardiac disease status was compensated.
Key inclusion criteria (3 listed)
- All the included patients have BUN-to-creatinne ratio>20
- LV-EF between 35% and 50%
- Normal RV function indices [tricuspid annular plane systolic excursion (TAPSE) index > 16 and tricuspid annular systolic velocity (TASV) > 10 cm/sec and fractional area change (FAC) > 35%)]
Key exclusion criteria (4 listed)
- Poor acoustic windows,
- Tthose who were included during the initial screening, but they finally found with pulmonary hypertension (peak tricuspid velocity > 3.4 m/sec), tricuspid/mitral/pulmonary valve regurgitation grade 3 or 4, severe aortic/mitral valve stenosis, and severe mitral annulus calcification on the preoperative echocardiogram.
- All patients with maximum cephalad dermatomal extension of the spinal sensory block below T12 or arterial hypotension related to overt intraoperative bleeding (>150 cc) are excluded.
- Intraoperrative hypotension due to bleeding and cement placement
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 |
|---|---|---|
| Point of care ultrasonographyAlso: Fluid-crystaloid co-loading immediately after spinal anesthesiaTransthoracic echocardiogrpahy followed spinal anesthesia and 5 ml/kg Ringers lactate fluid co-loading | Diagnostic test | – |
Primary outcome
Number of hypotension events after spinal anesthesia in patients with crystaloids co-loading guided by transthoracic echocardiogrpahy
Time frame: Thirty seconds
Patients with Mean arterial pressure (MAP) ≤ 65 mmHg, or with a reduction ≥ 25% of baseline pre-operative values are considered hypotensive
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 16 Jun 2026.
- Background: PubMed 36805418Moschovaki N, Saranteas T, Spiliotaki E, Giannoulis D, Anagnostopoulos D, Talliou C, Milionis O, Briassoulis P, Katogiannis K, Papadimos T. Point of care transthoracic echocardiography for the prediction of post - spinal anesthesia hypotension in elderly patients with cardiac diseases and left ventricular dysfunction : Inferior vena cava and post-spinal anesthesia hypotension in elderly patients. J Clin Monit Comput. 2023 Oct;37(5):1207-1218. doi: 10.1007/s10877-023-00981-y. Epub 2023 Feb 21.
- 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.
Theodosios Saranteas, MD, PhD principal investigator
University of Athens
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 Fluid Therapy and Dehydration, run by Attikon Hospital at 1 site in Greece.
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 4 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 16 Jun 2026. 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 Greece. 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?
Number of hypotension events after spinal anesthesia in patients with crystaloids co-loading guided by transthoracic echocardiogrpahy (time frame: Thirty seconds). 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 NCT06206434, 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 16 Jun 2026.