ShockNCT06730087
Cardiometry in Hypotensive and Pumonary Congestion
An observational study of Shock and Pulmonary Congestion, run by Assiut University at 2 sites in Egypt.
Trial summary
Assessment of validity of electrical cardiometry (EC) to measure fluid responsiveness and extravascular lung water that is expressed in the form of (thoracic fluid content) . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shock, Pulmonary Congestion
- How many people
- 80 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Dec 2024to 1 Sep 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: The study will be conducted in Assiut University Hospital, in respiratory intensive care unit. This study is a cross sectional design for Extravascular lung water and fluid responsiveness assessment in critically ill patient
Who may be able to join
- Patients who are 18 years old or more.
- patients will be divided into two groups: Group 1 patients with blood pressure less than 90/60 to assess fluid responsiveness and group 2 patients with sonographic finding of increase extravascular lung water in the form of interstitial edema or pulmonary edema or by electrical cardiometry (increase thoracic fluid content).
Who cannot join
- Patients less than 18 years old.
- Patients who refuse to participate in the study.
- eria:
- -
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites
faculty of mdicine Assiut university
Asyut, Asyut Governorate, 71111
Mostafa Mahmoud, 01012125498, mostafamahmoud826@gmail.com
faculty of medicine Assiut university
Asyut, 71111
About this study
Official title: Extravascular Lung Water and Fluid Responsiveness in Critically Ill Patient
Assessment of validity of electrical cardiometry (EC) to measure fluid responsiveness and extravascular lung water that is expressed in the form of (thoracic fluid content) .
Read the detailed description
- Study Setting: The study will be conducted in Assiut University Hospital, in respiratory intensive care unit. This study is a cross sectional design for Extravascular lung water and fluid responsiveness assessment in critically ill patient
- Study subjects:
- Inclusion criteria:
- Patients who are 18 years old or more.
- patients will be divided into two groups: Group 1 patients with blood pressure less than 90/60 to assess fluid responsiveness and group 2 patients with sonographic finding of increase extravascular lung water in the form of interstitial edema or pulmonary edema or by electrical cardiometry (increase thoracic fluid content).
- Exclusion criteria:
- Patients less than 18 years old.
- Patients who refuse to participate in the study.
- Sample Size Calculation: Sample size was calculated using the Buderer's formula for sensitivity and specificity of diagnostic health studies described by Zaidi et. al. 1 For Electrical Cardiometry in the fluid responsiveness group, the following inputs were used: expected sensitivity of Electrical Cardiometry in fluid responsiveness = 81%, expected specificity = 90%, expected sensitivity for ultrasound = 90% (8,9) , desired precision = 10%, and confidence level = 90%. The calculated sample size was 50 cases. For Electrical Cardiometry in the congestion group, the inputs were: expected sensitivity of Electrical Cardiometry in congestion = 89%, expected specificity = 83%, expected sensitivity for ultrasound = 88% (10,11),desired precision = 10%, and confidence level = 90%. The calculated sample size was 30 cases.
- Zaidi, S. M. H., Waseem, H. F., Ansari, F. A., Irfan, M., Fahim, S., \& Ahmad, M. (2016, March). Sample size estimation of diagnostic test studies in health sciences. In Proceedings of 14th International Conference on Statistical Sciences (Vol. 29, pp. 239-246).
- Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, …):
Methods:
Electrocardiometry:
The method of electrical cardiometry requires the use of 4 ECG electrodes, 2 attached to the left side of the neck and 2 attached at the lower thorax. An electrical alternating current (AC) of constant amplitude is applied via the pair of outer electrodes toward the thorax and in particular the ascending and descending aorta. Current is directed toward the aorta because blood is the most conductive material in the thorax. The ratio of applied current and measured voltage equals the conductivity (or bioimpedance), which is recorded over time. The steep increase in conductivity seen beat to beat is attributed to the orientation of red blood cells. The time when the slope is most steep is directly related to the peak aortic blood acceleration (12).
ICON® Parameters Blood Flow SV/SI HR CO/CI Stroke Volume / Stroke Index Heart Rate Cardiac Output /Cardiac Index Vascular System SVR /SVRI Systemic Vascular Resistance/ SVR-Index based on input of MAP and CVP Contractility ICON™ VIC™ STR Index of Contractility Variation of Index of Contractility Systolic Time Ratio (PEP/LVET) CPI Cardiac Performance Index Fluid Status TFC Thoracic Fluid Content SVV Stroke Volume Variation FTC Corrected Flow Time Oxygen Status DO2 / DO2I Oxygen Delivery / DO2-Index based on input of Hemoglobin and SpO2
IVC distensibility index:
In mechanically ventilated patients, the IVC distensibility index is calculated using the formula: IVC distensibility index = [(maximum diameter on inspiration-minimum diameter on expiration)/minimum diameter on expiration] (9). fluid responsiveness if it is \> 18% (13).
Chest Ultrasonography A zone was considered positive for pulmonary congestion if ≥3 B-lines were shown (14).
Action plan and outcomes
- All patients\' data regarding age, gender, sex and essential diagnosis will be taken.
- Patients\' vital signs especially blood pressure and heart rate and rhythm.
- Hemoglobin level will be acquired for all patients.
- In intubated patients with blood pressure less than 90/60 fluid will be given500 mL crystalloids according Stroke volume variation (SVV) and thoracic fluid index. Fluid responsiveness was defined as SVV \>10% to 15% suggests that the patient is fluid responsiveness as indicates that stroke volume is sensitive to fluctuations in preload caused by the respiratory cycle. Comparing fluid responsiveness first measurement between SVV by electrocardiometry and IVC distensibility. Other parameters of electrocariometery will be documented.
- In patients clinically suspected pulmonary edema will be evaluated by ultrasonography and by electrical cardiometry
- CVP will be measured.
- Incidence of mortality, duration of MV and duration of ICU stay will be acquired for patients. (4) Research outcome measures:
- Primary (main): electric cardiometry effectiveness in fluid management in critically ill patient b. Secondary (subsidiary): (5)Data management and analysis (Details needed): Data collection: medical records Computer software IBM SPSS software version 22.0 (SPSS Inc.,Chicago,IL) Statistical tests Statistical tests Normality of data will be assessed using Shapiro walk test. Normally distributed data will be represented as mean ± SD,median9range0 and numbers(%),chi square test or fisher\'s exac test will be used in categorical data .independent t-test will be used to compare between parametric data,Mann-Whitney will be used to compare non parametric values in the studied groups.p-value\<0.05 will be considered statistically significant. (6)References (max. 15) and written in Vancouver style:
- Marik P, Bellomo R. A rational approach to fluid therapy in sepsis. BJA: British Journal of Anaesthesia [Internet]. 2016 Mar 1 [cited 2024 Jul 29];116(3):339-49. Available from: https://dx.doi.org/10.1093/bja/aev349
- Rehberg S, Enkhbaatar P, Traber DL. Arginine vasopressin in septic shock: supplement or substitute for norepinephrine? Crit Care. 2009;13(4):178.
- Marik PE, Baram M, Vahid B. Does central venous pressure predict fluid responsiveness? A systematic review of the literature and the tale of seven mares. Chest [Internet]. 2008 [cited 2024 Jul 29];134(1):172-8. Available from: https://pubmed.ncbi.nlm.nih.gov/18628220/
- Magder S. Fluid status and fluid responsiveness. Curr Opin Crit Care [Internet]. 2010 Aug [cited 2024 Jul 29];16(4):289-96. Available from: https://pubmed.ncbi.nlm.nih.gov/20543685/
- Cherpanath TGV, Lagrand WK, Schultz MJ, Groeneveld ABJ. Cardiopulmonary interactions during mechanical ventilation in critically ill patients. Neth Heart J [Internet]. 2013 Apr [cited 2024 Jul 29];21(4):166-72. Available from: https://pubmed.ncbi.nlm.nih.gov/23460128/
- Cherpanath TGV, Geerts BF, Lagrand WK, Schultz MJ, Groeneveld ABJ. Basic concepts of fluid responsiveness. Netherlands Heart Journal [Internet]. 2013 Dec [cited 2024 Jul 29];21(12):530. Available from: /pmc/articles/PMC3833913/
- Summers RL, Shoemaker WC, Peacock WF, Ander DS, Coleman TG. Bench to bedside: electrophysiologic and clinical principles of noninvasive hemodynamic monitoring using impedance cardiography. Acad Emerg Med [Internet]. 2003 Jun 1 [cited 2024 Jul 30];10(6):669-80. Available from: https://pubmed.ncbi.nlm.nih.gov/12782531/
- Yao B, Liu JY, Sun YB, Zhao YX, Li L Di. The value of the inferior vena cava area distensibility index and its diameter ratio for predicting fluid responsiveness in mechanically ventilated patients. Shock. 2019 Jul 1;52(1):37-42.
- Sharkawy MS El, Abdelghany MS, Dabe AA El, Hafez AAA El. Validation of Electrical Cardiometry Measurements Compared to Transthoracic Echocardiography in Fluid Responsiveness in Sepsis. J Adv Med Med Res. 2022 Apr 26;10-20.
- Maw AM, Hassanin A, Ho PM, McInnes MDF, Moss A, Juarez-Colunga E, et al. Diagnostic Accuracy of Point-of-Care Lung Ultrasonography and Chest Radiography in Adults With Symptoms Suggestive of Acute Decompensated Heart Failure: A Systematic Review and Meta-analysis. JAMA Netw Open [Internet]. 2019 Mar 1 [cited 2024 Sep 16];2(3):e190703. Available from: /pmc/articles/PMC6484641/
- Mahmoud KH, Mokhtar MS, Soliman RA, Khaled MM. Non invasive adjustment of fluid status in critically ill patients on renal replacement therapy. Role of Electrical Cardiometry. The Egyptian Journal of Critical Care Medicine. 2016 Aug;4(2):57-65.
- ICON® - Portable Noninvasive Cardiometer │ OSYPKA MEDICAL [Internet]. [cited 2024 Aug 6]. Available from: https://www.osypkamed.com/products/electrical-cardiometry/icon/
- Lujan Varas J, Martinez Díaz C, Blancas R, Martinez Gonzalez O, Llorente Ruiz B, Molina Montero R, et al. Inferior vena cava distensibility index predicting fluid responsiveness in ventilated patients. Intensive Care Medicine Experimental . 2015;3.
- Dávila-Román VG, Checkley W. Lung Ultrasound in Cardiac Intensive Care. Circ Cardiovasc Imaging [Internet]. 2020 Jun 1 [cited 2024 Sep 4];13(6):E010909. Available from: https://www.ahajournals.org/doi/10.1161/CIRCIMAGING.120.010909
- Conditions
- Shock, Pulmonary Congestion
- Keywords
- cardiometry
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 2 groups which will compare cardiometry with ultrasound | patients will be divided into two groups: Group 1 patients with blood pressure less than 90/60 to assess fluid responsiveness and group 2 patients with sonographic finding of increase extravascular lung water in the form of interstitial edema or pulmonary edema or by electrical cardiometry (increase thoracic fluid content). |
What is being measured
The primary outcome is the main question the study is designed to answer.
electric cardiometry effectiveness in fluid management in critically ill patient
compairing fluid responsiveness by stroke vloume variation in carddiometry( Fluid responsiveness was defined as SVV >10% to 15%) and IVC destinsability index by ultrasound (fluid rspnisveness was defined as [(maximum IVC diameter on inspiration-minimum diameter on expiration)/minimum diameter on expiration] > 18%). compairing pulmonary edema by fluid thoracic content(normal range:25 to 35) in cardiometry and B lines in chest ultrasound(more than 3 b-lines in all 4 fields/BLUE points considered positive for pulmonary edema according to BLUE protocol).
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShockStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Mahmoud, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06730087
- Sponsor's protocol ID
- cardiometry in critically ill
- Status last verified
- Dec 2024
- First submitted
- 6 Nov 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extravascular Lung Water and Fluid Responsiveness in Critically Ill Patient
- ClinicalTrials.gov ID
- NCT06730087
- Acronym / sponsor ID
- cardiometry in critically ill
- Conditions
- Shock, Pulmonary Congestion
- Keywords
- cardiometry
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 12 Dec 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.
Assessment of validity of electrical cardiometry (EC) to measure fluid responsiveness and extravascular lung water that is expressed in the form of (thoracic fluid content) .
Detailed description
- Study Setting: The study will be conducted in Assiut University Hospital, in respiratory intensive care unit. This study is a cross sectional design for Extravascular lung water and fluid responsiveness assessment in critically ill patient
- Study subjects:
- Inclusion criteria:
- Patients who are 18 years old or more.
- patients will be divided into two groups: Group 1 patients with blood pressure less than 90/60 to assess fluid responsiveness and group 2 patients with sonographic finding of increase extravascular lung water in the form of interstitial edema or pulmonary edema or by electrical cardiometry (increase thoracic fluid content).
- Exclusion criteria:
- Patients less than 18 years old.
- Patients who refuse to participate in the study.
- Sample Size Calculation: Sample size was calculated using the Buderer's formula for sensitivity and specificity of diagnostic health studies described by Zaidi et. al. 1 For Electrical Cardiometry in the fluid responsiveness group, the following inputs were used: expected sensitivity of Electrical Cardiometry in fluid responsiveness = 81%, expected specificity = 90%, expected sensitivity for ultrasound = 90% (8,9) , desired precision = 10%, and confidence level = 90%. The calculated sample size was 50 cases. For Electrical Cardiometry in the congestion group, the inputs were: expected sensitivity of Electrical Cardiometry in congestion = 89%, expected specificity = 83%, expected sensitivity for ultrasound = 88% (10,11),desired precision = 10%, and confidence level = 90%. The calculated sample size was 30 cases.
- Zaidi, S. M. H., Waseem, H. F., Ansari, F. A., Irfan, M., Fahim, S., \& Ahmad, M. (2016, March). Sample size estimation of diagnostic test studies in health sciences. In Proceedings of 14th International Conference on Statistical Sciences (Vol. 29, pp. 239-246).
- Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, …):
Methods:
Electrocardiometry:
The method of electrical cardiometry requires the use of 4 ECG electrodes, 2 attached to the left side of the neck and 2 attached at the lower thorax. An electrical alternating current (AC) of constant amplitude is applied via the pair of outer electrodes toward the thorax and in particular the ascending and descending aorta. Current is directed toward the aorta because blood is the most conductive material in the thorax. The ratio of applied current and measured voltage equals the conductivity (or bioimpedance), which is recorded over time. The steep increase in conductivity seen beat to beat is attributed to the orientation of red blood cells. The time when the slope is most steep is directly related to the peak aortic blood acceleration (12).
ICON® Parameters Blood Flow SV/SI HR CO/CI Stroke Volume / Stroke Index Heart Rate Cardiac Output /Cardiac Index Vascular System SVR /SVRI Systemic Vascular Resistance/ SVR-Index based on input of MAP and CVP Contractility ICON™ VIC™ STR Index of Contractility Variation of Index of Contractility Systolic Time Ratio (PEP/LVET) CPI Cardiac Performance Index Fluid Status TFC Thoracic Fluid Content SVV Stroke Volume Variation FTC Corrected Flow Time Oxygen Status DO2 / DO2I Oxygen Delivery / DO2-Index based on input of Hemoglobin and SpO2
IVC distensibility index:
In mechanically ventilated patients, the IVC distensibility index is calculated using the formula: IVC distensibility index = [(maximum diameter on inspiration-minimum diameter on expiration)/minimum diameter on expiration] (9). fluid responsiveness if it is \> 18% (13).
Chest Ultrasonography A zone was considered positive for pulmonary congestion if ≥3 B-lines were shown (14).
Action plan and outcomes
- All patients\' data regarding age, gender, sex and essential diagnosis will be taken.
- Patients\' vital signs especially blood pressure and heart rate and rhythm.
- Hemoglobin level will be acquired for all patients.
- In intubated patients with blood pressure less than 90/60 fluid will be given500 mL crystalloids according Stroke volume variation (SVV) and thoracic fluid index. Fluid responsiveness was defined as SVV \>10% to 15% suggests that the patient is fluid responsiveness as indicates that stroke volume is sensitive to fluctuations in preload caused by the respiratory cycle. Comparing fluid responsiveness first measurement between SVV by electrocardiometry and IVC distensibility. Other parameters of electrocariometery will be documented.
- In patients clinically suspected pulmonary edema will be evaluated by ultrasonography and by electrical cardiometry
- CVP will be measured.
- Incidence of mortality, duration of MV and duration of ICU stay will be acquired for patients. (4) Research outcome measures:
- Primary (main): electric cardiometry effectiveness in fluid management in critically ill patient b. Secondary (subsidiary): (5)Data management and analysis (Details needed): Data collection: medical records Computer software IBM SPSS software version 22.0 (SPSS Inc.,Chicago,IL) Statistical tests Statistical tests Normality of data will be assessed using Shapiro walk test. Normally distributed data will be represented as mean ± SD,median9range0 and numbers(%),chi square test or fisher\'s exac test will be used in categorical data .independent t-test will be used to compare between parametric data,Mann-Whitney will be used to compare non parametric values in the studied groups.p-value\<0.05 will be considered statistically significant. (6)References (max. 15) and written in Vancouver style:
- Marik P, Bellomo R. A rational approach to fluid therapy in sepsis. BJA: British Journal of Anaesthesia [Internet]. 2016 Mar 1 [cited 2024 Jul 29];116(3):339-49. Available from: https://dx.doi.org/10.1093/bja/aev349
- Rehberg S, Enkhbaatar P, Traber DL. Arginine vasopressin in septic shock: supplement or substitute for norepinephrine? Crit Care. 2009;13(4):178.
- Marik PE, Baram M, Vahid B. Does central venous pressure predict fluid responsiveness? A systematic review of the literature and the tale of seven mares. Chest [Internet]. 2008 [cited 2024 Jul 29];134(1):172-8. Available from: https://pubmed.ncbi.nlm.nih.gov/18628220/
- Magder S. Fluid status and fluid responsiveness. Curr Opin Crit Care [Internet]. 2010 Aug [cited 2024 Jul 29];16(4):289-96. Available from: https://pubmed.ncbi.nlm.nih.gov/20543685/
- Cherpanath TGV, Lagrand WK, Schultz MJ, Groeneveld ABJ. Cardiopulmonary interactions during mechanical ventilation in critically ill patients. Neth Heart J [Internet]. 2013 Apr [cited 2024 Jul 29];21(4):166-72. Available from: https://pubmed.ncbi.nlm.nih.gov/23460128/
- Cherpanath TGV, Geerts BF, Lagrand WK, Schultz MJ, Groeneveld ABJ. Basic concepts of fluid responsiveness. Netherlands Heart Journal [Internet]. 2013 Dec [cited 2024 Jul 29];21(12):530. Available from: /pmc/articles/PMC3833913/
- Summers RL, Shoemaker WC, Peacock WF, Ander DS, Coleman TG. Bench to bedside: electrophysiologic and clinical principles of noninvasive hemodynamic monitoring using impedance cardiography. Acad Emerg Med [Internet]. 2003 Jun 1 [cited 2024 Jul 30];10(6):669-80. Available from: https://pubmed.ncbi.nlm.nih.gov/12782531/
- Yao B, Liu JY, Sun YB, Zhao YX, Li L Di. The value of the inferior vena cava area distensibility index and its diameter ratio for predicting fluid responsiveness in mechanically ventilated patients. Shock. 2019 Jul 1;52(1):37-42.
- Sharkawy MS El, Abdelghany MS, Dabe AA El, Hafez AAA El. Validation of Electrical Cardiometry Measurements Compared to Transthoracic Echocardiography in Fluid Responsiveness in Sepsis. J Adv Med Med Res. 2022 Apr 26;10-20.
- Maw AM, Hassanin A, Ho PM, McInnes MDF, Moss A, Juarez-Colunga E, et al. Diagnostic Accuracy of Point-of-Care Lung Ultrasonography and Chest Radiography in Adults With Symptoms Suggestive of Acute Decompensated Heart Failure: A Systematic Review and Meta-analysis. JAMA Netw Open [Internet]. 2019 Mar 1 [cited 2024 Sep 16];2(3):e190703. Available from: /pmc/articles/PMC6484641/
- Mahmoud KH, Mokhtar MS, Soliman RA, Khaled MM. Non invasive adjustment of fluid status in critically ill patients on renal replacement therapy. Role of Electrical Cardiometry. The Egyptian Journal of Critical Care Medicine. 2016 Aug;4(2):57-65.
- ICON® - Portable Noninvasive Cardiometer │ OSYPKA MEDICAL [Internet]. [cited 2024 Aug 6]. Available from: https://www.osypkamed.com/products/electrical-cardiometry/icon/
- Lujan Varas J, Martinez Díaz C, Blancas R, Martinez Gonzalez O, Llorente Ruiz B, Molina Montero R, et al. Inferior vena cava distensibility index predicting fluid responsiveness in ventilated patients. Intensive Care Medicine Experimental . 2015;3.
- Dávila-Román VG, Checkley W. Lung Ultrasound in Cardiac Intensive Care. Circ Cardiovasc Imaging [Internet]. 2020 Jun 1 [cited 2024 Sep 4];13(6):E010909. Available from: https://www.ahajournals.org/doi/10.1161/CIRCIMAGING.120.010909
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2 groups which will compare cardiometry with ultrasound | – | –patients will be divided into two groups: Group 1 patients with blood pressure less than 90/60 to assess fluid responsiveness and group 2 patients with sonographic finding of increase extravascular lung water in the form of interstitial edema or pulmonary edema or by electrical cardiometry (increase thoracic fluid content). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be conducted in Assiut University Hospital, in respiratory intensive care unit. This study is a cross sectional design for Extravascular lung water and fluid responsiveness assessment in critically ill patient
Key inclusion criteria (2 listed)
- Patients who are 18 years old or more.
- patients will be divided into two groups: Group 1 patients with blood pressure less than 90/60 to assess fluid responsiveness and group 2 patients with sonographic finding of increase extravascular lung water in the form of interstitial edema or pulmonary edema or by electrical cardiometry (increase thoracic fluid content).
Key exclusion criteria (4 listed)
- Patients less than 18 years old.
- Patients who refuse to participate in the study.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
electric cardiometry effectiveness in fluid management in critically ill patient
Time frame: baseline
compairing fluid responsiveness by stroke vloume variation in carddiometry( Fluid responsiveness was defined as SVV >10% to 15%) and IVC destinsability index by ultrasound (fluid rspnisveness was defined as [(maximum IVC diameter on inspiration-minimum diameter on expiration)/minimum diameter on expiration] > 18%). compairing pulmonary edema by fluid thoracic content(normal range:25 to 35) in cardiometry and B lines in chest ultrasound(more than 3 b-lines in all 4 fields/BLUE points considered positive for pulmonary edema according to BLUE protocol).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Shock
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
RecruitingObservational study
Hemophagocytic Lymphohistiocytosis (HLH) Evaluation and Research of Clinical, ImmUnoLogic and TranscriptomE Study
Lymphohistiocytosis, Hemophagocytic, Secondary Hemophagocytic Lymphohistiocytosis
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shock and Pulmonary Congestion, run by Assiut University at 2 sites 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 2 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: opening soon, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mostafa Mahmoud Attia (00201012125498, mostafamahmoud826@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
electric cardiometry effectiveness in fluid management in critically ill patient (time frame: baseline). 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 12 Dec 2024.