Circulatory FailureNCT03622099
Small Volume Fluid Challenge as a Predictor of Fluid Responsiveness in Patients With Circulatory Failure
An observational study of Circulatory Failure, run by Menoufia University at 1 site in Egypt.
Trial summary
Assessment of intravascular volume status is difficult in critically ill patients. Evidence suggests that only 50% of hemodynamically unstable patients respond to a fluid challenge. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Circulatory Failure
- What is being tested?
- Normal Saline Flush, 0.9% Injectable Solution
- Type of treatment
- Injection or infusion
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Sep 2018to 26 Feb 2019
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: in a general adult critical care unit (CCU) at Menoufia University Hospitals
Who may be able to join
- Patients with acute circulatory failure
- Mechanically ventilated \& sedated.(Tidal volume 6-8 ml/ kg, PEEP 5 mmHg, Richmond Agitation-Sedation Scale RASS (R) Score from zero to -3).
- Systemic inflammatory response syndrome
- Septic shock
- Controlled massive hemorrhage
Who cannot join
- Age of less than 18 years
- Cardiomyopathy
- Pulmonary edema
- Morbid obesity
- Pregnancy
- Increased intracranial tension
- Valvular heart disease
- Myocardial ischemia or infarction before the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transthoracic Echocardiography Guided Small Volume Fluid Challenge as a Predictor of Fluid Responsiveness in Patients With Circulatory Failure: An Observational Study
Assessment of intravascular volume status is difficult in critically ill patients. Evidence suggests that only 50% of hemodynamically unstable patients respond to a fluid challenge. Moreover, if cardiopulmonary function cannot compensate for the increase in preload, fluid loading may compromise microvascular perfusion and oxygen delivery and cause or aggravate peripheral and pulmonary edema. Inappropriate fluid expansion can increase morbidity and mortality thus making it important to accurately assess fluid responsiveness in critically ill patients. The volume responsiveness can be defined as a 15% increase in stroke volume (SV) or cardiac output (CO) after a 500-ml infusion. This study tested whether echocardiographic parameters can predict fluid responsiveness in critically ill patients following a low volume 100-ml crystalloid solution infusion over 1 minute.
Read the detailed description
Fifty-four adult patients with circulatory failure were recruited for the study. As a routine work in adult critical care unit at Menoufia University hospital for patients with circulatory failure, a 100 ml bolus of normal saline solution was given to the patient over 1 minute through a central venous catheter or jugular cannula. For prediction of responders, echocardiographic parameters were recorded1 minute after bolus administration. The remaining 400 ml of normal saline solution was infused at a constant rate over 10 minutes, and echocardiographic parameters were recorded again. The mean echocardiographic measurements over three consecutive respiratory cycles were recorded along with heart rate HR, systolic, diastolic and mean arterial pressures, central venous pressure, and Temperature also mechanical ventilation parameter (tidal volume, respiratory rate and PEEP) for each patient. Patients with an increase in CO after a 100 ml or total 500-ml infusion over 10 minutes (ΔCO500) of 15% or more were classified as responders (Rs) and those without an increase in CO was classified as non-responders
- Conditions
- Circulatory Failure
- Being tested
- Normal Saline Flush, 0.9% Injectable Solution
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal Saline Flush, 0.9% Injectable SolutionDrug
Also called normal saline
As a routine work in adult critical care unit at Menoufia University hospital for patients with circulatory failure, A 100 ml bolus of Normal Saline Flush, 0.9% Injectable Solution was given to the patient over 1 minute through a central venous catheter or jugular cannula. For prediction of responders, echocardiographic parameters measured followed by infusion of the remaining 400 ml of Normal Saline Flush, 0.9% Injectable Solution at a constant rate over 10 minutes then echocardiographic parameters measured again to detect the patient response.
| Study group | Role | What they receive |
|---|---|---|
| The study group | As a routine work in adult critical care unit at Menoufia University hospital for patients with circulatory failure, A 100 ml bolus of Normal Saline Flush, 0.9% Injectable Solution was given to the patient over 1 minute through a central venous catheter or jugular cannula. For prediction of responders, echocardiographic parameters measured followed by infusion of the remaining 400 ml of Normal Saline Flush, 0.9% Injectable Solution at a constant rate over 10 minutes then echocardiographic parameters measured again to detect the patient response. Receives: Drug: Normal Saline Flush, 0.9% Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aortic blood flow velocity Time Integral changes from the baseline
[cm]
Measured: Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge
Secondary outcomes (10)
stroke volume change from the baseline
[ml/beat]
Measured: Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge
cardiac output change from the baseline
[ liter/minute]
Measured: Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge
heart rate change from the baseline
[beats/minute]
Measured: Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge
systolic blood pressure change from the baseline
[mmHg]
Measured: Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge
Diastolic blood pressure change from the baseline
[mmHg]
Measured: Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge
Central venous pressure change from the baseline
[Cm water]
Measured: Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge
Mean arterial blood pressure change from the baseline
[mmHg]
Measured: Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge
Left ventricular end systolic diameter change from the baseline
[Cm]
Measured: Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge
Left ventricular end diastolic diameter change from the baseline
[Cm]
Measured: Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge
Aortic root diameter change from the baseline
[Cm]
Measured: Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start7 Sep 2018
- Primary completion5 Feb 2019
- Study completion26 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circulatory FailureStudies of the same condition, open and under way.
- More trials run by Menoufia 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abd-Elazeem Abd-Elhameed Elbakry, Menoufia University
- Investigators
- Abd-Elazeem A Elbakry, M.D, Study chair, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03622099
- Sponsor's protocol ID
- 2017/3/1/4
- Status last verified
- Apr 2019
- First submitted
- 30 Jul 2018
- Last updated
- 25 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the paper protocol only we share if the paper is published in a closed access journal. For open access no problem for sharing the whole data
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transthoracic Echocardiography Guided Small Volume Fluid Challenge as a Predictor of Fluid Responsiveness in Patients With Circulatory Failure: An Observational Study
- ClinicalTrials.gov ID
- NCT03622099
- Acronym / sponsor ID
- 2017/3/1/4
- Conditions
- Circulatory Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 7 Sep 2018 (actual)
- Primary completion
- 5 Feb 2019 (actual)
- Study completion
- 26 Feb 2019 (actual)
- First posted
- 9 Aug 2018 (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 intravascular volume status is difficult in critically ill patients. Evidence suggests that only 50% of hemodynamically unstable patients respond to a fluid challenge. Moreover, if cardiopulmonary function cannot compensate for the increase in preload, fluid loading may compromise microvascular perfusion and oxygen delivery and cause or aggravate peripheral and pulmonary edema. Inappropriate fluid expansion can increase morbidity and mortality thus making it important to accurately assess fluid responsiveness in critically ill patients. The volume responsiveness can be defined as a 15% increase in stroke volume (SV) or cardiac output (CO) after a 500-ml infusion. This study tested whether echocardiographic parameters can predict fluid responsiveness in critically ill patients following a low volume 100-ml crystalloid solution infusion over 1 minute.
Detailed description
Fifty-four adult patients with circulatory failure were recruited for the study. As a routine work in adult critical care unit at Menoufia University hospital for patients with circulatory failure, a 100 ml bolus of normal saline solution was given to the patient over 1 minute through a central venous catheter or jugular cannula. For prediction of responders, echocardiographic parameters were recorded1 minute after bolus administration. The remaining 400 ml of normal saline solution was infused at a constant rate over 10 minutes, and echocardiographic parameters were recorded again. The mean echocardiographic measurements over three consecutive respiratory cycles were recorded along with heart rate HR, systolic, diastolic and mean arterial pressures, central venous pressure, and Temperature also mechanical ventilation parameter (tidal volume, respiratory rate and PEEP) for each patient. Patients with an increase in CO after a 100 ml or total 500-ml infusion over 10 minutes (ΔCO500) of 15% or more were classified as responders (Rs) and those without an increase in CO was classified as non-responders
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The study group | – | Drug: Normal Saline Flush, 0.9% Injectable SolutionAs a routine work in adult critical care unit at Menoufia University hospital for patients with circulatory failure, A 100 ml bolus of Normal Saline Flush, 0.9% Injectable Solution was given to the patient over 1 minute through a central venous catheter or jugular cannula. For prediction of responders, echocardiographic parameters measured followed by infusion of the remaining 400 ml of Normal Saline Flush, 0.9% Injectable Solution at a constant rate over 10 minutes then echocardiographic parameters measured again to detect the patient response. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- in a general adult critical care unit (CCU) at Menoufia University Hospitals
Key inclusion criteria (5 listed)
- Patients with acute circulatory failure
- Mechanically ventilated \& sedated.(Tidal volume 6-8 ml/ kg, PEEP 5 mmHg, Richmond Agitation-Sedation Scale RASS (R) Score from zero to -3).
- Systemic inflammatory response syndrome
- Septic shock
- Controlled massive hemorrhage
Key exclusion criteria (8 listed)
- Age of less than 18 years
- Cardiomyopathy
- Pulmonary edema
- Morbid obesity
- Pregnancy
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 Saline Flush, 0.9% Injectable SolutionAlso: normal salineAs a routine work in adult critical care unit at Menoufia University hospital for patients with circulatory failure, A 100 ml bolus of Normal Saline Flush, 0.9% Injectable Solution was given to the patient over 1 minute through a central venous catheter or jugular cannula. For prediction of responders, echocardiographic parameters measured followed by infusion of the remaining 400 ml of Normal Saline Flush, 0.9% Injectable Solution at a constant rate over 10 minutes then echocardiographic parameters measured again to detect the patient response. | Drug | The study group |
Primary outcome
Aortic blood flow velocity Time Integral changes from the baseline
Time frame: Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge
[cm]
10 secondary outcomes
stroke volume change from the baseline
Time frame: Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge
cardiac output change from the baseline
Time frame: Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge
heart rate change from the baseline
Time frame: Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge
systolic blood pressure change from the baseline
Time frame: Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge
Diastolic blood pressure change from the baseline
Time frame: Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge
Central venous pressure change from the baseline
Time frame: Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge
Mean arterial blood pressure change from the baseline
Time frame: Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge
Left ventricular end systolic diameter change from the baseline
Time frame: Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge
Left ventricular end diastolic diameter change from the baseline
Time frame: Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge
Aortic root diameter change from the baseline
Time frame: Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge
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 25 Apr 2019.
- Individual participant dataSharing planned: Yes. the paper protocol only we share if the paper is published in a closed access journal. For open access no problem for sharing the whole data
Related trials for Circulatory Failure
Active, not recruiting
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A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
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.
Abd-Elazeem A Elbakry, M.D study chair
Menoufia 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 Circulatory Failure, run by Menoufia 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 5 inclusion and 8 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 25 Apr 2019. 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?
Aortic blood flow velocity Time Integral changes from the baseline (time frame: Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge). 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 25 Apr 2019.