SepsisNCT03179215
Dynamic Arterial Elastance as a Predictor of Arterial Blood Pressure Response to Fluid Administration in Septic Patients
An observational study of Sepsis, run by Cairo University at 1 site in Egypt.
Trial summary
Correction of arterial hypotension is essential for adequate cellular metabolism. maintaining MAP above a minimum level has been recommended in order to prevent further tissue hypoperfusion and organ dysfunction.Functional assessment of arterial load by dynamic arterial elastance (Eadyn), has recently been shown to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- fluid challange
- How many people
- 58 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2017to 30 Jun 2018
- 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 years and older
- All sexes
- Adult, Older adult
Study population: All adult patients with the diagnosis of sepsis who will be admitted to the Trauma and Surgical Intensive Care Unit (SICU) of Kasralainy School of Medicine,Cairo University during a 6-month period (from March 2017 to September 2017) will be enrolled in the study.Sepsis is defined according to Surviving Sepsis Campaign: International Guidelines for Management of Severe Sepsis and Septic Shock: 2016 as life-threatening organ dysfunction due to a dysregulated host response to infection.10 Septic shock is defined as a subset of sepsis in which particularly profound circulatory, cellular, and metabolic abnormalities substantially increase mortality.
Who may be able to join
- Adult patients (more than 18 years).
- Sepsis as a cause of admission.
Who cannot join
- • Patients younger than 18 years of age.
- Pregnant females.
- Trauma as a cause of intensive care unit (ICU)admission.
- Known medical history of vasodilator therapy.
- Cardiac arrhythmias.
- Any absolute contraindication for fluid administration such as congestive heart failure, pulmonary edema and/or fluid overload
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Trauma & Surgical ICU. New Emergency Hospital (185 Hospital)
Cairo, 9999
About this study
Correction of arterial hypotension is essential for adequate cellular metabolism. maintaining MAP above a minimum level has been recommended in order to prevent further tissue hypoperfusion and organ dysfunction.Functional assessment of arterial load by dynamic arterial elastance (Eadyn), has recently been shown to predict the arterial pressure response to volume expansion (VE) in hypotensive, preload-dependent septic patients.
Read the detailed description
After approval from the ethics and research committee of Faculty of Medicine, Cairo University, an informed consent will be obtained from each patient's next of kin. Arteial cathter will be inserted in radial artery and connected through an arterial line to invasive arterial blood pressure monitor. Electrical Cardiometry will be attached to patient through the placement of four skin sensors on the neck and left side of the thorax12. A set of hemodynamic measurements will be obtained at baseline and after infusing a fluid challenge (FC) of 150-250 ml normal saline over 5-10 minutes.Fluid-responders are patients with a SV increase ≥10% after fluid challenge (FC).
- Conditions
- Sepsis
- Being tested
- fluid challange
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluid challangeDiagnostic test
A set of hemodynamic measurements will be obtained at baseline and after infusing a fluid challenge (FC) of 150-250 ml normal saline over 5-10 minutes.Fluid-responders are patients with a SV increase ≥10% after fluid challenge
What is being measured
The primary outcome is the main question the study is designed to answer.
dynamic arterial elastance
confirm the ability of non invasive (Eadyn) for predicting arterial pressure response to fluid challenge in septic patients
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start1 Jul 2017
- Primary completion31 Dec 2017
- Study completion30 Jun 2018
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.
- More trials run by Cairo 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 crossover
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, soudy salah hammad, Cairo University
- Investigators
- ahmed m mukhtar, proffesor, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03179215
- Sponsor's protocol ID
- N-35 -2017
- Status last verified
- Jul 2018
- First submitted
- 5 Jun 2017
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Garcia MI, Romero MG, Cano AG, Aya HD, Rhodes A, Grounds RM, Cecconi M. Dynamic arterial elastance as a predictor of arterial pressure response to fluid administration: a validation study. Crit Care. 2014 Nov 19;18(6):626. doi: 10.1186/s13054-014-0626-6.
PubMed 25407570Cecconi M, Monge Garcia MI, Gracia Romero M, Mellinghoff J, Caliandro F, Grounds RM, Rhodes A. The use of pulse pressure variation and stroke volume variation in spontaneously breathing patients to assess dynamic arterial elastance and to predict arterial pressure response to fluid administration. Anesth Analg. 2015 Jan;120(1):76-84. doi: 10.1213/ANE.0000000000000442.
PubMed 25230102
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Arterial Elastance as a Predictor of Arterial Blood Pressure Response to Fluid Administration in Septic Patients
- ClinicalTrials.gov ID
- NCT03179215
- Acronym / sponsor ID
- N-35 -2017
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 7 Jun 2017 (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.
Correction of arterial hypotension is essential for adequate cellular metabolism. maintaining MAP above a minimum level has been recommended in order to prevent further tissue hypoperfusion and organ dysfunction.Functional assessment of arterial load by dynamic arterial elastance (Eadyn), has recently been shown to predict the arterial pressure response to volume expansion (VE) in hypotensive, preload-dependent septic patients.
Detailed description
After approval from the ethics and research committee of Faculty of Medicine, Cairo University, an informed consent will be obtained from each patient's next of kin. Arteial cathter will be inserted in radial artery and connected through an arterial line to invasive arterial blood pressure monitor. Electrical Cardiometry will be attached to patient through the placement of four skin sensors on the neck and left side of the thorax12. A set of hemodynamic measurements will be obtained at baseline and after infusing a fluid challenge (FC) of 150-250 ml normal saline over 5-10 minutes.Fluid-responders are patients with a SV increase ≥10% after fluid challenge (FC).
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All adult patients with the diagnosis of sepsis who will be admitted to the Trauma and Surgical Intensive Care Unit (SICU) of Kasralainy School of Medicine,Cairo University during a 6-month period (from March 2017 to September 2017) will be enrolled in the study.Sepsis is defined according to Surviving Sepsis Campaign: International Guidelines for Management of Severe Sepsis and Septic Shock: 2016 as life-threatening organ dysfunction due to a dysregulated host response to infection.10 Septic shock is defined as a subset of sepsis in which particularly profound circulatory, cellular, and metabolic abnormalities substantially increase mortality.
Key inclusion criteria (2 listed)
- Adult patients (more than 18 years).
- Sepsis as a cause of admission.
Key exclusion criteria (6 listed)
- • Patients younger than 18 years of age.
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 |
|---|---|---|
| fluid challangeA set of hemodynamic measurements will be obtained at baseline and after infusing a fluid challenge (FC) of 150-250 ml normal saline over 5-10 minutes.Fluid-responders are patients with a SV increase ≥10% after fluid challenge | Diagnostic test | – |
Primary outcome
dynamic arterial elastance
Time frame: 6 month
confirm the ability of non invasive (Eadyn) for predicting arterial pressure response to fluid challenge in septic patients
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 17 Jul 2018.
- Background: PubMed 25407570Garcia MI, Romero MG, Cano AG, Aya HD, Rhodes A, Grounds RM, Cecconi M. Dynamic arterial elastance as a predictor of arterial pressure response to fluid administration: a validation study. Crit Care. 2014 Nov 19;18(6):626. doi: 10.1186/s13054-014-0626-6.
- Background: PubMed 25230102Cecconi M, Monge Garcia MI, Gracia Romero M, Mellinghoff J, Caliandro F, Grounds RM, Rhodes A. The use of pulse pressure variation and stroke volume variation in spontaneously breathing patients to assess dynamic arterial elastance and to predict arterial pressure response to fluid administration. Anesth Analg. 2015 Jan;120(1):76-84. doi: 10.1213/ANE.0000000000000442.
- Individual participant dataSharing planned: Undecided
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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.
ahmed m mukhtar, proffesor principal investigator
Cairo 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 Sepsis, run by Cairo 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 6 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 17 Jul 2018. 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?
dynamic arterial elastance (time frame: 6 month). 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 NCT03179215, 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 17 Jul 2018.