Septic ShockNCT05612529
Fluid Responseveness in Sepsis and Its Correlation to CVP
An observational study of Septic Shock, run by Assiut University at 1 site in Egypt.
Trial summary
Introduction Aim of the work Patients and methods Type of study Exclusion criteria Statistical analysis Research ethics Reference Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Septic Shock
- What is being tested?
- US , Echocardiography
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2022to 30 Nov 2022
- 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 18 to 75 years
- All sexes
- Adult, Older adult
Study population: After recording these data, the patients will be administered a fluid challenge of a 500 mL fluid bolus of 0.9% normal saline over 10 min and then same haemodynamic parameters will be measured again. Fluid responsiveness is an increase of stroke volume of 10-15% by echocardiography, after the patient receives 500 ml of crystalloid over 10 min.
Who may be able to join
- adult patients age≥18-year-old; written consent will be obtained.
- septic shocked patients show signs of acute circulatory failure at any time within the first 72 hours.
Who cannot join
- Patients confirmed to have cardiogenic shock.
- History of heart failure or patient known to have moderate to severe valvular heart disease, congenital heart disease.
- The presence of carotid artery stenosis >50% , newly detected common carotid stenosis >50% during the study period.
- Non-sinus rhythm.
- Moderate to severe anemia.
- Markedly increased intraabdominal pressure as abdominal compartment syndrome, pregnancy.
- Medically diseased kidneys, ureteric obstruction peri-nephric collection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasonographic Predictors of Intravenous Fluid Responsiveness in Septic Shock and Its Correlation to Central Venous Pressure
Introduction Aim of the work Patients and methods Type of study Exclusion criteria Statistical analysis Research ethics Reference
Read the detailed description
Septic shock is a serious infectious condition characterized by low blood pressure and multiple organ damage. One of the traditional recommendations is to administer intravenous fluids as the first step to improve blood pressure(1).
However, studies have shown that not every patient benefits from aggressive intravenous hydration (2).
Previous studies have shown that certain parameters may correlate with volume status and others may not to correlate with patient volume status.
Hemodynamic parameters, such as stroke volume variation (SVV) and pleth variability index (PVI) may better predict fluid responsiveness. However, assessments of these parameters require invasive procedures and special monitoring equipment, which limits their clinical application (4).
Echocardiography has been widely adopted to diagnose and monitor cardiac dysfunction leading to hemodynamic instability, and shock pathophysiology in general.
However, the echocardiographic information on macro-hemodynamics is partial, especially as being indirect as concerns vascular tone, and not allowing any inference on end-organ perfusion (5).
Recently, ultrasonography for estimating volume status has been widely recommended because of its non-invasive nature, ease of acquisition, and reproducibility of measurements.
The inferior vena cava (IVC) is a compliant vessel whose size and shape vary with changes in CVP and intravascular volume. Therefore, sonographic measurement of the IVC represents an effective and non-invasive method of estimating CVP.
Respiratory variation in the IVC diameter was used as a guide for fluid therapy in septic shock in both spontaneous breathing and mechanically ventilated patients.
Moreover, the assessment of visceral end-organ perfusion by ultrasound, may offer insights into this facet of shock pathophysiology (5).
Among these ultrasound modalities, corrected flow time (FTc) measured in the carotid artery is a new approach for predicting fluid responsiveness that has shown promising results.
Therefore, although it is a dynamic index, it may be able to adequately evaluate volume status in spontaneously and mechanically breathing patients.
Aim of the work: 1- To evaluate whether carotid FTc as determined by Doppler ultrasound could be a predictor of fluid responsiveness in spontaneously breathing and mechanically ventilated patients.
2- To evaluate the predictive ability of ΔVpeak for fluid responsiveness in spontaneously breathing patients.
3- To detect changes of regional splanchnic hemodynamics by color Doppler resistive index, and its improvement after fluid administration.
4- To evaluate the predictive ability of IVC collapsibility and distensibility indices for fluid responsiveness in septic shock patients.
5- To compare between the predictive ability of the measured Ultrasonographic parameters and the CVP changes in response to intravenous fluid therapy in both spontaneously breathing and mechanically ventilated septic shock patients.
- Conditions
- Septic Shock
- Being tested
- US , Echocardiography
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
US , EchocardiographyDevice
- Carotid ultrasonography: Parameters will be measured by single blinded independent examiner using an ultrasound device. Baseline carotid FTc, ΔVpeak, will be measured.
- Echocardiography: Stroke Volume will be measured by transthoracic echocardiography.
- Renal and splenic Doppler resistivity index.
- Inferior vena cava collapsibility and distensibility indices.
- Central venous pressure estimation by central venous catheter, and central - Lung ultrasound for detection of lung congestion
- Lung ultrasound for detection of lung congestion.
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasonographic predictors of intravenous fluid responsiveness in septic shock and its correlation to central venous pressure
To evaluate whether carotid FTc as determined by Doppler ultrasound could be a predictor of fluid responsiveness in spontaneously breathing and MV patients.
Measured: Baseline
Evaluation the predictive ability of ΔVpeak for fluid responsiveness in spontaneously breathing patients.
To evaluate the predictive ability of ΔVpeak for fluid responsiveness in spontaneously breathing patients.
and the ΔVpeak will be calculated as follows: (maximum peak velocity - minimum peak velocity)/[(maximum peak velocity + minimum peak velocity)/2] × 100
Measured: Baseline
Detection changes of regional splanchnic hemodynamics by color Doppler resistive index, and its improvement after fluid administration.
To detect changes of regional splanchnic hemodynamics by color Doppler resistive index, and its improvement after fluid administration.
Resistive index (RI): (peak systolic velocity - end-diastolic velocity) / peak systolic velocity. The normal range is 0.50-0.70.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start1 Apr 2022
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Why it stopped: increase mortality rate in cases that made it difficult to follow up
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Septic 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tasneem Hassan Younes, Assiut University
- Investigators
- olfat M elshinawy, professor, Principal investigator, Assiut Universitymohamed M abdelhady, professor, Principal investigator, Assiut Universityarafa M aboelhassan, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05612529
- Sponsor's protocol ID
- fluid responseveness in sepsis
- Status last verified
- Jan 2023
- First submitted
- 27 Oct 2021
- Last updated
- 30 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Levy MM, Evans LE, Rhodes A. The Surviving Sepsis Campaign Bundle: 2018 update. Intensive Care Med. 2018 Jun;44(6):925-928. doi: 10.1007/s00134-018-5085-0. Epub 2018 Apr 19. No abstract available.
PubMed 29675566Vandervelden S, Malbrain ML. Initial resuscitation from severe sepsis: one size does not fit all. Anaesthesiol Intensive Ther. 2015;47 Spec No:s44-55. doi: 10.5603/AIT.a2015.0075. Epub 2015 Nov 18.
PubMed 26578400Lammi MR, Aiello B, Burg GT, Rehman T, Douglas IS, Wheeler AP, deBoisblanc BP; National Institutes of Health, National Heart, Lung, and Blood Institute ARDS Network Investigators. Response to fluid boluses in the fluid and catheter treatment trial. Chest. 2015 Oct;148(4):919-926. doi: 10.1378/chest.15-0445.
PubMed 26020673Hu B, Xiang H, Liang H, Yu L, Xu T, Yang JH, DU ZH, Li JG. Assessment effect of central venous pressure in fluid resuscitation in the patients with shock: a multi-center retrospective research. Chin Med J (Engl). 2013;126(10):1844-9.
PubMed 23673097Corradi F, Via G, Tavazzi G. What's new in ultrasound-based assessment of organ perfusion in the critically ill: expanding the bedside clinical monitoring window for hypoperfusion in shock. Intensive Care Med. 2020 Apr;46(4):775-779. doi: 10.1007/s00134-019-05791-y. Epub 2019 Oct 25. No abstract available.
PubMed 31654077Kim HJ, Choi YS, Kim SH, Lee W, Kwon JY, Kim DH. Predictability of preoperative carotid artery-corrected flow time for hypotension after spinal anaesthesia in patients undergoing caesarean section: A prospective observational study. Eur J Anaesthesiol. 2021 Apr 1;38(4):394-401. doi: 10.1097/EJA.0000000000001376.
PubMed 33122575
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Predictors of Intravenous Fluid Responsiveness in Septic Shock and Its Correlation to Central Venous Pressure
- ClinicalTrials.gov ID
- NCT05612529
- Acronym / sponsor ID
- fluid responseveness in sepsis
- Conditions
- Septic Shock
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: increase mortality rate in cases that made it difficult to follow up
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 10 Nov 2022 (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.
Introduction Aim of the work Patients and methods Type of study Exclusion criteria Statistical analysis Research ethics Reference
Detailed description
Septic shock is a serious infectious condition characterized by low blood pressure and multiple organ damage. One of the traditional recommendations is to administer intravenous fluids as the first step to improve blood pressure(1).
However, studies have shown that not every patient benefits from aggressive intravenous hydration (2).
Previous studies have shown that certain parameters may correlate with volume status and others may not to correlate with patient volume status.
Hemodynamic parameters, such as stroke volume variation (SVV) and pleth variability index (PVI) may better predict fluid responsiveness. However, assessments of these parameters require invasive procedures and special monitoring equipment, which limits their clinical application (4).
Echocardiography has been widely adopted to diagnose and monitor cardiac dysfunction leading to hemodynamic instability, and shock pathophysiology in general.
However, the echocardiographic information on macro-hemodynamics is partial, especially as being indirect as concerns vascular tone, and not allowing any inference on end-organ perfusion (5).
Recently, ultrasonography for estimating volume status has been widely recommended because of its non-invasive nature, ease of acquisition, and reproducibility of measurements.
The inferior vena cava (IVC) is a compliant vessel whose size and shape vary with changes in CVP and intravascular volume. Therefore, sonographic measurement of the IVC represents an effective and non-invasive method of estimating CVP.
Respiratory variation in the IVC diameter was used as a guide for fluid therapy in septic shock in both spontaneous breathing and mechanically ventilated patients.
Moreover, the assessment of visceral end-organ perfusion by ultrasound, may offer insights into this facet of shock pathophysiology (5).
Among these ultrasound modalities, corrected flow time (FTc) measured in the carotid artery is a new approach for predicting fluid responsiveness that has shown promising results.
Therefore, although it is a dynamic index, it may be able to adequately evaluate volume status in spontaneously and mechanically breathing patients.
Aim of the work: 1- To evaluate whether carotid FTc as determined by Doppler ultrasound could be a predictor of fluid responsiveness in spontaneously breathing and mechanically ventilated patients.
2- To evaluate the predictive ability of ΔVpeak for fluid responsiveness in spontaneously breathing patients.
3- To detect changes of regional splanchnic hemodynamics by color Doppler resistive index, and its improvement after fluid administration.
4- To evaluate the predictive ability of IVC collapsibility and distensibility indices for fluid responsiveness in septic shock patients.
5- To compare between the predictive ability of the measured Ultrasonographic parameters and the CVP changes in response to intravenous fluid therapy in both spontaneously breathing and mechanically ventilated septic shock patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- After recording these data, the patients will be administered a fluid challenge of a 500 mL fluid bolus of 0.9% normal saline over 10 min and then same haemodynamic parameters will be measured again. Fluid responsiveness is an increase of stroke volume of 10-15% by echocardiography, after the patient receives 500 ml of crystalloid over 10 min.
Key inclusion criteria (2 listed)
- adult patients age≥18-year-old; written consent will be obtained.
- septic shocked patients show signs of acute circulatory failure at any time within the first 72 hours.
Key exclusion criteria (7 listed)
- Patients confirmed to have cardiogenic shock.
- History of heart failure or patient known to have moderate to severe valvular heart disease, congenital heart disease.
- The presence of carotid artery stenosis >50% , newly detected common carotid stenosis >50% during the study period.
- Non-sinus rhythm.
- Moderate to severe anemia.
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 |
|---|---|---|
| US , Echocardiography* Carotid ultrasonography: Parameters will be measured by single blinded independent examiner using an ultrasound device. Baseline carotid FTc, ΔVpeak, will be measured. * Echocardiography: Stroke Volume will be measured by transthoracic echocardiography. * Renal and splenic Doppler resistivity index. * Inferior vena cava collapsibility and distensibility indices. * Central venous pressure estimation by central venous catheter, and central - Lung ultrasound for detection of lung congestion * Lung ultrasound for detection of lung congestion. | Device | – |
Primary outcome
Ultrasonographic predictors of intravenous fluid responsiveness in septic shock and its correlation to central venous pressure
Time frame: Baseline
To evaluate whether carotid FTc as determined by Doppler ultrasound could be a predictor of fluid responsiveness in spontaneously breathing and MV patients.
Evaluation the predictive ability of ΔVpeak for fluid responsiveness in spontaneously breathing patients.
Time frame: Baseline
To evaluate the predictive ability of ΔVpeak for fluid responsiveness in spontaneously breathing patients. and the ΔVpeak will be calculated as follows: (maximum peak velocity - minimum peak velocity)/[(maximum peak velocity + minimum peak velocity)/2] × 100
Detection changes of regional splanchnic hemodynamics by color Doppler resistive index, and its improvement after fluid administration.
Time frame: Baseline
To detect changes of regional splanchnic hemodynamics by color Doppler resistive index, and its improvement after fluid administration. Resistive index (RI): (peak systolic velocity - end-diastolic velocity) / peak systolic velocity. The normal range is 0.50-0.70.
Results and safety
The study was stopped early (reason given: increase mortality rate in cases that made it difficult to follow up). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
- Background: PubMed 29675566Levy MM, Evans LE, Rhodes A. The Surviving Sepsis Campaign Bundle: 2018 update. Intensive Care Med. 2018 Jun;44(6):925-928. doi: 10.1007/s00134-018-5085-0. Epub 2018 Apr 19. No abstract available.
- Background: PubMed 26578400Vandervelden S, Malbrain ML. Initial resuscitation from severe sepsis: one size does not fit all. Anaesthesiol Intensive Ther. 2015;47 Spec No:s44-55. doi: 10.5603/AIT.a2015.0075. Epub 2015 Nov 18.
- Background: PubMed 26020673Lammi MR, Aiello B, Burg GT, Rehman T, Douglas IS, Wheeler AP, deBoisblanc BP; National Institutes of Health, National Heart, Lung, and Blood Institute ARDS Network Investigators. Response to fluid boluses in the fluid and catheter treatment trial. Chest. 2015 Oct;148(4):919-926. doi: 10.1378/chest.15-0445.
- Background: PubMed 23673097Hu B, Xiang H, Liang H, Yu L, Xu T, Yang JH, DU ZH, Li JG. Assessment effect of central venous pressure in fluid resuscitation in the patients with shock: a multi-center retrospective research. Chin Med J (Engl). 2013;126(10):1844-9.
- Background: PubMed 31654077Corradi F, Via G, Tavazzi G. What's new in ultrasound-based assessment of organ perfusion in the critically ill: expanding the bedside clinical monitoring window for hypoperfusion in shock. Intensive Care Med. 2020 Apr;46(4):775-779. doi: 10.1007/s00134-019-05791-y. Epub 2019 Oct 25. No abstract available.
- Background: PubMed 33122575Kim HJ, Choi YS, Kim SH, Lee W, Kwon JY, Kim DH. Predictability of preoperative carotid artery-corrected flow time for hypotension after spinal anaesthesia in patients undergoing caesarean section: A prospective observational study. Eur J Anaesthesiol. 2021 Apr 1;38(4):394-401. doi: 10.1097/EJA.0000000000001376.
- Individual participant dataSharing planned: No
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Sepsis
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.
olfat M elshinawy, professor principal investigator
Assiut University
mohamed M abdelhady, professor principal investigator
Assiut University
arafa M aboelhassan principal investigator
Assiut University
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 Septic Shock, run by Assiut University 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 2 inclusion and 7 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: stopped early, as of the sponsor's last update on 30 Jan 2023. 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 was stopped early (reason given: increase mortality rate in cases that made it difficult to follow up). Results are not available in the source record.
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?
Ultrasonographic predictors of intravenous fluid responsiveness in septic shock and its correlation to central venous pressure (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05612529, which also lists 6 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 30 Jan 2023.