SepsisNCT05980494
Lung Ultrasound Score and Inferior Vena Cava Diameter Compared to Pulse Pressure Variation
A study testing normal Saline, lung ultrasound and inferior vena cava measurements in people with Sepsis and Critical Illness, run by Fayoum University Hospital at 1 site in Egypt.
Trial summary
Evaluation and management of intravascular volume are a central challenge for the critical ill patients. Hypotensive patients are commonly resuscitated with intravenous crystalloid fluid as a recommendation for treatment of many shock states. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Critical Illness
- What is being tested?
- normal Saline, lung ultrasound and inferior vena cava measurements
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Sep 2022to 20 Jun 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients on mechanical ventilation (MV).
- Aged more than 18 years.
- Mean arterial pressure (MAP) less than 65 mmHg or systolic arterial pressure less than 90mm Hg with signs of hypoperfusion (urinary flow < 0.5mL/kg/ h for > 2hr , tachycardia > 100 beats/min, or presence of skin mottling , and seurm lactate more than 2 mmol/L).
Who cannot join
- Cardiac arrhythmias.
- Previously known significant valvular disease or intracardiac shunt.
- Chest drains.
- Increasing intra abdominal pressure.
- Prephiral vascular disesaes.
- Adult respiratory distress syndrome (ARDS) patients due to low tidal volume.
Show all 10Show fewer
- Interstitial lung disease because B-lines in these conditions are the consequence of the thickened interlobular septa characterizing fibrosis and are not modified by the state of hydration or imbibition 12
- Any contraindication for fluid administration as cardiogenic shock, acute pulmonary edema or LVEF% less than 50%.
- Renal patients with oliguria and volume overload including patients on hemodialysis or patients with acute anuric renal failure.
- Patients with lower extremity artery/vein thrombosis, significant lower extremity artery plaque, lower extremity artery occlusion, inferior vena cava filter implantation and lower extremity varicose veins.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validity of Lung Ultrasound Score and Inferior Vena Cava Diameter Compared to Pulse Pressure Variation Predicting Fluid Responsiveness in Mechanically Ventilated Critically Ill Patients: a Comparative Study
Evaluation and management of intravascular volume are a central challenge for the critical ill patients. Hypotensive patients are commonly resuscitated with intravenous crystalloid fluid as a recommendation for treatment of many shock states.
There has been a growing interest in the implementation of lung ultrasound in critical care management in the last decade as it is easy, bedside, non-expensive, non invasive and radiation free.
The object of the current study is to assess the ability of lung and inferior vena cava sonography versus pulse pressure variation to predict fluid responsiveness in patients with circulatory failure on mechanical ventilation.
Read the detailed description
The study will be conducted in intensive care units of Fayoum University Hospitals after approval of the local institutional ethics committee and local institutional review board. Hypotensive Patients on mechanical ventilation starting from August 2022 will be enrolled in this prospective study until fulfilling sample size. A detailed informed consent will be signed before recruitment. All patients who fulfilled inclusion criteria will be monitored by: 6 leads ECG, Blood pressure, Urinary catheter for urine output, Pulse oximter.Lung ultrasound (LUS), Inferior vena cava ultrasound (IVC US) and pulse pressure variation (PPV) will be done to every patient in the study. The Consolidated standards of Reporting Trials (CONSORT) recommendation will be followed. LUS and IVC measurements were performed by using a convex ultrasound probe (Philips clear vue350, Philips healthcare, Andover MAO1810, USA, Machine ID: 1385). LUS will be performed by an experienced radiologist according to standardized protocols. For each hemi-thorax 3 main areas (anterior (Ant), lateral (Lt) and posterior (Post)) marked by the para-sternal, anterior axillary and posterior axillary lines for a total of 28 sectors will be identified. Each one will be divided into upper and lower halves, making a sum of 6 different quadrants for each side: anterior superior, anterior inferior, lateral superior, lateral inferior, posterior superior, posterior inferior. Ultrasound examination of the anterolateral chest was carried out with longitudinal scan of the right and left hemi thoraces, from the second to the fourth (on the right side to the fifth) intercostal space, as previously described. For each quadrant a score will be assigned based on B lines which are defined as an echogenic artifact with a narrow origin on the pleural line, deepening to the inferior border of the screen and coherent with respiratory movements indicating subpleural interstitial edema as follows:
(0) Normal aeration: A lines with lung sliding or fewer than two isolated B lines
- Moderate loss of lung aeration: well-defined, multiple B lines.
- Severe loss of lung aeration: multiple coalescent B lines.
- Complete loss of lung aeration or lung consolidation. This will be used to calculate total LUS-score (calculated as a sum of all quadrants score) and individual areas score (Ant, Lt and Post).
IVC US: The inferior vena cava was explored in the subxiphoid window in its sagittal view-just below the junction between the inferior vena cava and suprahepatic veins which lie approximately 0.5 to 3 cm from the right atrium, following the American Society of Echocardiography guidelines.; The (IVC distensibility index (dIVC) was calculated as (maximum diameter - minimum diameter)/minimum diameter.
PPV: patients will be temporarily sedated and paralyzed and on fully controlled mechanical ventilation. No spontaneous breathing effort will be detected on the mechanical ventilator waveform monitor ensuring that the respiratory changes in arterial pressure reflected only the effects of positive pressure ventilation. Modes of ventilation is selected to volume or pressure controlled ventilation, depending on the decision of the primary physicians. A tidal volume will be not less than 8 ml/ kg (predicted body weight). The preset respiratory rate will be at 14 breath/min. Positive end expiratory pressure (PEEP) will be between 8 and 10 cmH2O. The plateau pressure was kept at below 30 cmH2O. In all patients, radial artery cannulation will be done for invasive blood pressure monitoring (using a 20 G cannula), PPV is calculated directly on Nihon Kohden monitores at base line.
- Sample size: Sample size was calculated using MedCalc Statistical Software version 20 (MedCalc Software, Ostend, Belgium. Minimal sample size of patients was 118 patients with 59 responsive cases and 59 non-responsive cases. Calculation is guided by AUC of 0.915 obtained from a study in comparison to a null value of 0.8, with alpha of 0.05 and power of 90%. Sample size will be increased to 150 patients to increase precision and ensure that at least 59 responsive and 59 non-responsive cases are included.
- Statistical analysis: Data will be collected and coded using Microsoft Excel and data analysis will be performed using IBM SPSS version 28 for Windows. Descriptive statistics will be presented in the form of numbers and percentages of categorical data, while means with standard deviations or medians with interquartile ranges will be used for numerical data variables. ROC curve will be used to estimate the appropriate cut off point for the inferior vena cava distensibility index, and for the lung ultrasound score. Area under the curve (AUC) will be reported and will be used to compare the diagnostic ability of different tests. Sensitivity, specificity, positive predictive value and negative predictive value will be reported with the 95% confidence intervals. P-value < 0.05 will be considered statistically significant.
- Conditions
- Sepsis, Critical Illness
- Being tested
- normal Saline, lung ultrasound, inferior vena cava measurements, passive leg raising test (PLRT), pulse pressure variation
- Keywords
- lung utlrasound, pulse pressure variation, inferior vena cava, fluid responsiveness
- Medical subject headings
- Sepsis, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
normal SalineDrug
Also called Fluid challenge test
normal saline cyrstalloids infusion with rate of 4ml/kg /h for 3 hours
lung ultrasoundDevice
Lung ultrasound by Philips clear vue350, Philips healthcare, Andover MAO1810, USA, Machine ID:1385 will scan For each hemi-thorax 3 main areas (anterior (Ant), lateral (Lt) and posterior (Post)) marked by the para-sternal, anterior axillary and posterior axillary lines for a total of 28 sectors will be identified
inferior vena cava measurementsDevice
The inferior vena cava was explored in the subxiphoid window in its sagittal view-just below the junction between the inferior vena cava and suprahepatic veins which lie approximately 0.5 to 3 cm from the right atrium, following the American Society of Echocardiography guidelines.; The (IVC distensibility index (dIVC) was calculated as (maximum diameter - minimum diameter)/minimum diameter.
passive leg raising test (PLRT)Diagnostic test
Regardless of CVP (i.e., during "blind PLR"), noninvasiveΔPLR systolic arterial pressure (SAP) more than 17% reliably identify fluid responders. During "CVP-guided PLR", in case of sufficient change in CVP (at least of 2 mmHg), noninvasiveΔPLR SAP perform better (cutoff of 9%). These findings, in sedated patients who had already undergone volume expansion and/or catecholamines, have to be verified during the early phase of circulatory failure (before an arterial line).
pulse pressure variationDevice
patients will be temporarily sedated and paralyzed and on fully controlled mechanical ventilation. No spontaneous breathing effort will be detected on the mechanical ventilator waveform monitor ensuring that the respiratory changes in arterial pressure reflected only the effects of positive pressure ventilation. Modes of ventilation is selected to volume or pressure controlled ventilation, depending on the decision of the primary physicians. A tidal volume will be not less than 8 ml/ kg (predicted body weight). The preset respiratory rate will be at 14 breath/min. Positive end expiratory pressure (PEEP) will be between 8 and 10 cmH2O. The plateau pressure was kept at below 30 cmH2O. In all patients, radial artery cannulation will be done for invasive blood pressure monitoring (using a 20 G cannula), PPV is calculated directly on Nihon Kohden monitores at base line.
| Study group | Role | What they receive |
|---|---|---|
| Scanning group | Experimental | Lung ultrasound (LUS), Inferior vena cava ultrasound (IVC US) and pulse pressure variation (PPV) will be done to every patient in the study. Receives: Drug: normal Saline; Device: lung ultrasound; Device: inferior vena cava measurements; Diagnostic Test: passive leg raising test (PLRT); Device: pulse pressure variation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensitivity of lung ultrasound in predicting fluid responsiveness.
<0.8: non-sensitive, >0.8: sensitive
Measured: After 5 minutes of admission
Secondary outcomes (13)
lung ultrasound B lines score
(0) Normal aeration: A lines with lung sliding or fewer than two isolated B lines
- Moderate loss of lung aeration: well-defined, multiple B lines.
- Severe loss of lung aeration: multiple coalescent B lines.
- Complete loss of lung aeration or lung consolidation. This will be used to calculate total LUS-score (calculated as a sum of all quadrants score) and individual areas score (Ant, Lt and Post).
Measured: after 5 minutes of admission
Inferior vena cava distensibility index.
(maximum diameter - minimum diameter)/minimum diameter.
Measured: after 10 minutes of admission
pulse pressure variation
in percent
Measured: 15 minutes after admission
central venous pressure
in centimeter water
Measured: after 20 minutes of admission
heart rate
in beat per minute
Measured: 5 minutes after admission
serum lactate
in ml equivalent per liter
Measured: after 30 minutes of admission
urine output
in ml/ hour
Measured: in 1 hour after admission
length of stay in ICU
in days
Measured: 1 hour after discharge
specificity of lung ultrasound predicting fluid responsiveness
<0.8 non specific > 0.8 specific
Measured: 5 minutes after admission
sensitivity of IVC ultrasound predicting fluid responsiveness
<0.8 non sensitive >0.8 sensitive
Measured: after 5 minutes of admission
sensitivity of pulse pressure variation predicting fluid responsiveness
<0.8 non sensitive >0.8 sensitive
Measured: after 5 minutes of admission
specificity of IVC ultrasound predicting fluid responsiveness
<0.8 non sensitive >0.8 sensitive
Measured: after 5 minutes of admission
specificity of pulse pressure variation predicting fluid responsiveness
<0.8 non sensitive >0.8 sensitive
Measured: after 5 minutes of admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start13 Sep 2022
- Primary completion20 May 2024
- Study completion20 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Hamed, Fayoum University Hospital
- Investigators
- omar S farghaly, MD, Study director, lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05980494
- Sponsor's protocol ID
- D 310
- Status last verified
- Mar 2025
- First submitted
- 31 Jul 2023
- Last updated
- 12 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chvojka J, Matejovic M. [International guidelines for management of severe sepsis and septic shock 2012 - comment]. Vnitr Lek. 2014 Jan;60(1):59-67. Czech.
PubMed 24564777Haddam M, Zieleskiewicz L, Perbet S, Baldovini A, Guervilly C, Arbelot C, Noel A, Vigne C, Hammad E, Antonini F, Lehingue S, Peytel E, Lu Q, Bouhemad B, Golmard JL, Langeron O, Martin C, Muller L, Rouby JJ, Constantin JM, Papazian L, Leone M; CAR'Echo Collaborative Network; AzuRea Collaborative Network. Lung ultrasonography for assessment of oxygenation response to prone position ventilation in ARDS. Intensive Care Med. 2016 Oct;42(10):1546-1556. doi: 10.1007/s00134-016-4411-7. Epub 2016 Jun 20.
PubMed 27324241
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of Lung Ultrasound Score and Inferior Vena Cava Diameter Compared to Pulse Pressure Variation Predicting Fluid Responsiveness in Mechanically Ventilated Critically Ill Patients: a Comparative Study
- ClinicalTrials.gov ID
- NCT05980494
- Acronym / sponsor ID
- D 310
- Conditions
- Sepsis, Critical Illness
- Keywords
- lung utlrasound, pulse pressure variation, inferior vena cava, fluid responsiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Fayoum University HospitalUniversity, hospital or other
- Study start
- 13 Sep 2022 (actual)
- Primary completion
- 20 May 2024 (actual)
- Study completion
- 20 Jun 2024 (actual)
- First posted
- 8 Aug 2023 (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.
Evaluation and management of intravascular volume are a central challenge for the critical ill patients. Hypotensive patients are commonly resuscitated with intravenous crystalloid fluid as a recommendation for treatment of many shock states.
There has been a growing interest in the implementation of lung ultrasound in critical care management in the last decade as it is easy, bedside, non-expensive, non invasive and radiation free.
The object of the current study is to assess the ability of lung and inferior vena cava sonography versus pulse pressure variation to predict fluid responsiveness in patients with circulatory failure on mechanical ventilation.
Detailed description
The study will be conducted in intensive care units of Fayoum University Hospitals after approval of the local institutional ethics committee and local institutional review board. Hypotensive Patients on mechanical ventilation starting from August 2022 will be enrolled in this prospective study until fulfilling sample size. A detailed informed consent will be signed before recruitment. All patients who fulfilled inclusion criteria will be monitored by: 6 leads ECG, Blood pressure, Urinary catheter for urine output, Pulse oximter.Lung ultrasound (LUS), Inferior vena cava ultrasound (IVC US) and pulse pressure variation (PPV) will be done to every patient in the study. The Consolidated standards of Reporting Trials (CONSORT) recommendation will be followed. LUS and IVC measurements were performed by using a convex ultrasound probe (Philips clear vue350, Philips healthcare, Andover MAO1810, USA, Machine ID: 1385). LUS will be performed by an experienced radiologist according to standardized protocols. For each hemi-thorax 3 main areas (anterior (Ant), lateral (Lt) and posterior (Post)) marked by the para-sternal, anterior axillary and posterior axillary lines for a total of 28 sectors will be identified. Each one will be divided into upper and lower halves, making a sum of 6 different quadrants for each side: anterior superior, anterior inferior, lateral superior, lateral inferior, posterior superior, posterior inferior. Ultrasound examination of the anterolateral chest was carried out with longitudinal scan of the right and left hemi thoraces, from the second to the fourth (on the right side to the fifth) intercostal space, as previously described. For each quadrant a score will be assigned based on B lines which are defined as an echogenic artifact with a narrow origin on the pleural line, deepening to the inferior border of the screen and coherent with respiratory movements indicating subpleural interstitial edema as follows:
(0) Normal aeration: A lines with lung sliding or fewer than two isolated B lines
- Moderate loss of lung aeration: well-defined, multiple B lines.
- Severe loss of lung aeration: multiple coalescent B lines.
- Complete loss of lung aeration or lung consolidation. This will be used to calculate total LUS-score (calculated as a sum of all quadrants score) and individual areas score (Ant, Lt and Post).
IVC US: The inferior vena cava was explored in the subxiphoid window in its sagittal view-just below the junction between the inferior vena cava and suprahepatic veins which lie approximately 0.5 to 3 cm from the right atrium, following the American Society of Echocardiography guidelines.; The (IVC distensibility index (dIVC) was calculated as (maximum diameter - minimum diameter)/minimum diameter.
PPV: patients will be temporarily sedated and paralyzed and on fully controlled mechanical ventilation. No spontaneous breathing effort will be detected on the mechanical ventilator waveform monitor ensuring that the respiratory changes in arterial pressure reflected only the effects of positive pressure ventilation. Modes of ventilation is selected to volume or pressure controlled ventilation, depending on the decision of the primary physicians. A tidal volume will be not less than 8 ml/ kg (predicted body weight). The preset respiratory rate will be at 14 breath/min. Positive end expiratory pressure (PEEP) will be between 8 and 10 cmH2O. The plateau pressure was kept at below 30 cmH2O. In all patients, radial artery cannulation will be done for invasive blood pressure monitoring (using a 20 G cannula), PPV is calculated directly on Nihon Kohden monitores at base line.
- Sample size: Sample size was calculated using MedCalc Statistical Software version 20 (MedCalc Software, Ostend, Belgium. Minimal sample size of patients was 118 patients with 59 responsive cases and 59 non-responsive cases. Calculation is guided by AUC of 0.915 obtained from a study in comparison to a null value of 0.8, with alpha of 0.05 and power of 90%. Sample size will be increased to 150 patients to increase precision and ensure that at least 59 responsive and 59 non-responsive cases are included.
- Statistical analysis: Data will be collected and coded using Microsoft Excel and data analysis will be performed using IBM SPSS version 28 for Windows. Descriptive statistics will be presented in the form of numbers and percentages of categorical data, while means with standard deviations or medians with interquartile ranges will be used for numerical data variables. ROC curve will be used to estimate the appropriate cut off point for the inferior vena cava distensibility index, and for the lung ultrasound score. Area under the curve (AUC) will be reported and will be used to compare the diagnostic ability of different tests. Sensitivity, specificity, positive predictive value and negative predictive value will be reported with the 95% confidence intervals. P-value < 0.05 will be considered statistically significant.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Scanning group | Experimental | Drug: normal Saline, Device: lung ultrasound, Device: inferior vena cava measurements, Diagnostic Test: passive leg raising test (PLRT), Device: pulse pressure variationLung ultrasound (LUS), Inferior vena cava ultrasound (IVC US) and pulse pressure variation (PPV) will be done to every patient in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients on mechanical ventilation (MV).
- Aged more than 18 years.
- Mean arterial pressure (MAP) less than 65 mmHg or systolic arterial pressure less than 90mm Hg with signs of hypoperfusion (urinary flow < 0.5mL/kg/ h for > 2hr , tachycardia > 100 beats/min, or presence of skin mottling , and seurm lactate more than 2 mmol/L).
Key exclusion criteria (10 listed)
- Cardiac arrhythmias.
- Previously known significant valvular disease or intracardiac shunt.
- Chest drains.
- Increasing intra abdominal pressure.
- Prephiral vascular disesaes.
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 |
|---|---|---|
| normal SalineAlso: Fluid challenge testnormal saline cyrstalloids infusion with rate of 4ml/kg /h for 3 hours | Drug | Scanning group |
| lung ultrasoundLung ultrasound by Philips clear vue350, Philips healthcare, Andover MAO1810, USA, Machine ID:1385 will scan For each hemi-thorax 3 main areas (anterior (Ant), lateral (Lt) and posterior (Post)) marked by the para-sternal, anterior axillary and posterior axillary lines for a total of 28 sectors will be identified | Device | Scanning group |
| inferior vena cava measurementsThe inferior vena cava was explored in the subxiphoid window in its sagittal view-just below the junction between the inferior vena cava and suprahepatic veins which lie approximately 0.5 to 3 cm from the right atrium, following the American Society of Echocardiography guidelines.; The (IVC distensibility index (dIVC) was calculated as (maximum diameter - minimum diameter)/minimum diameter. | Device | Scanning group |
| passive leg raising test (PLRT)Regardless of CVP (i.e., during "blind PLR"), noninvasiveΔPLR systolic arterial pressure (SAP) more than 17% reliably identify fluid responders. During "CVP-guided PLR", in case of sufficient change in CVP (at least of 2 mmHg), noninvasiveΔPLR SAP perform better (cutoff of 9%). These findings, in sedated patients who had already undergone volume expansion and/or catecholamines, have to be verified during the early phase of circulatory failure (before an arterial line). | Diagnostic test | Scanning group |
| pulse pressure variationpatients will be temporarily sedated and paralyzed and on fully controlled mechanical ventilation. No spontaneous breathing effort will be detected on the mechanical ventilator waveform monitor ensuring that the respiratory changes in arterial pressure reflected only the effects of positive pressure ventilation. Modes of ventilation is selected to volume or pressure controlled ventilation, depending on the decision of the primary physicians. A tidal volume will be not less than 8 ml/ kg (predicted body weight). The preset respiratory rate will be at 14 breath/min. Positive end expiratory pressure (PEEP) will be between 8 and 10 cmH2O. The plateau pressure was kept at below 30 cmH2O. In all patients, radial artery cannulation will be done for invasive blood pressure monitoring (using a 20 G cannula), PPV is calculated directly on Nihon Kohden monitores at base line. | Device | Scanning group |
Primary outcome
The sensitivity of lung ultrasound in predicting fluid responsiveness.
Time frame: After 5 minutes of admission
<0.8: non-sensitive, >0.8: sensitive
13 secondary outcomes
lung ultrasound B lines score
Time frame: after 5 minutes of admission
Inferior vena cava distensibility index.
Time frame: after 10 minutes of admission
pulse pressure variation
Time frame: 15 minutes after admission
central venous pressure
Time frame: after 20 minutes of admission
heart rate
Time frame: 5 minutes after admission
serum lactate
Time frame: after 30 minutes of admission
urine output
Time frame: in 1 hour after admission
length of stay in ICU
Time frame: 1 hour after discharge
specificity of lung ultrasound predicting fluid responsiveness
Time frame: 5 minutes after admission
sensitivity of IVC ultrasound predicting fluid responsiveness
Time frame: after 5 minutes of admission
sensitivity of pulse pressure variation predicting fluid responsiveness
Time frame: after 5 minutes of admission
specificity of IVC ultrasound predicting fluid responsiveness
Time frame: after 5 minutes of admission
specificity of pulse pressure variation predicting fluid responsiveness
Time frame: after 5 minutes of admission
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 12 Mar 2025.
- Background: PubMed 24564777Chvojka J, Matejovic M. [International guidelines for management of severe sepsis and septic shock 2012 - comment]. Vnitr Lek. 2014 Jan;60(1):59-67. Czech.
- Background: PubMed 27324241Haddam M, Zieleskiewicz L, Perbet S, Baldovini A, Guervilly C, Arbelot C, Noel A, Vigne C, Hammad E, Antonini F, Lehingue S, Peytel E, Lu Q, Bouhemad B, Golmard JL, Langeron O, Martin C, Muller L, Rouby JJ, Constantin JM, Papazian L, Leone M; CAR'Echo Collaborative Network; AzuRea Collaborative Network. Lung ultrasonography for assessment of oxygenation response to prone position ventilation in ARDS. Intensive Care Med. 2016 Oct;42(10):1546-1556. doi: 10.1007/s00134-016-4411-7. Epub 2016 Jun 20.
- 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.
omar S farghaly, MD study director
lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing normal Saline, lung ultrasound and inferior vena cava measurements in people with Sepsis and Critical Illness, run by Fayoum University Hospital at 1 site in Egypt.
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 10 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 12 Mar 2025. 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 Egypt. 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?
The sensitivity of lung ultrasound in predicting fluid responsiveness. (time frame: After 5 minutes of admission). 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 NCT05980494, which also lists 2 linked publications.
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 12 Mar 2025.