SepsisNCT06860438
Observational Study About the Use of Perfusion Index to Use Vasopressor in Sepsis
An observational study of Sepsis and Perfusion Index, run by Ain Shams University at 1 site in Egypt.
Trial summary
In this thesis we will use the current state of knowledge that PI can provide a reliable information about the state of peripheral microcirculation during the state of sepsis and septic shock in ICU patients and that can interfere with the timing of starting vasopressor treatment in sepsis and septic shock Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Perfusion Index, Vasopressor
- What is being tested?
- Vasoconstrictor Agents
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2024to Mar 2025
- 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: ICU patients with sepsis
Who may be able to join
- All ICU patients with clinically suspected sepsis and septic shock ( signs include fever hypotension oliguria and confusion combined with culture results showing infection .Septic shock is a subset of sepsis involves persistent hypotension (mean arterial pressure ≥ 65 mm Hg, and a serum lactate level > 18 mg/dL [2 mmol/L)not responding to fluid resuscitation ) .
Who cannot join
- Pregnant females
- Patients on vasopressor or positive inotropic drugs
- Patients with hypothermia (defined as central temperature <35°C).
- Patient with impairment of upper extremity circulation,(such as those who underwent radial artery harvesting for coronary artery bypass grafting or had suspected occlusion of the radial artery prior to surgery,)
- Patients had undergone an operation that involved the large arteries of the aortic arch.
- Patients with atherosclerosis .
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
faculty of medicine Ain Shams University
Cairo, 11757
About this study
Official title: Can Perfusion Index Indicate the Need of Vasopressor in ICU Patients with Sepsis and Septic Shock, Prospective Observational Study
In this thesis we will use the current state of knowledge that PI can provide a reliable information about the state of peripheral microcirculation during the state of sepsis and septic shock in ICU patients and that can interfere with the timing of starting vasopressor treatment in sepsis and septic shock
Read the detailed description
Septic shock is the leading cause of death worldwide, with in-hospital and intensive care mortality rates of 11.9% to 47.2%, depending on the setting and severity of the disease .
Endothelial dysfunction is a key element in sepsis pathophysiology. It is responsible for the sepsis-induced hypotension. So the essential step in the management of sepsis is to increase systemic and regional/microcirculatory flow. Increasing arterial blood pressure (ABP) with vasopressors when patients are hypotensive is used to improve the input pressure driving organ perfusion .
Experts' recommendations currently position norepinephrine (NE) as the first-line vasopressor in septic shock. Its early administration may allow achieving the initial mean arterial pressure (MAP) target faster and reducing the risk of fluid overload. However , controversies still exist on some issues such as, whether very early use of norepinephrine (NE) could improve outcome, whether individualized target of mean arterial pressure (MAP) should be applied . Perfusion index (PI) is a reliable noninvasive indicator of peripheral perfusion derived from the photoelectric plethysmographic (PPG) signal of a pulse oximetry . The perfusion index (PI) represents the ratio of pulsatile on non-pulsatile light absorbance or reflectance of the PPG signal. PI determinants are complex and interlinked, involving and reflecting the interaction between peripheral and central hemodynamic characteristics, such as vascular tone and stroke volume. Recently, several studies have shed light on the interesting performances of this variable, especially assessing hemodynamic monitoring in anesthesia, perioperative and intensive care.
Peripheral perfusion index is an early predictor of central hypovolemia. In a prospective observational study in an emergency department, PPI was not significantly different between patients admitted to the hospital and patients discharged from the emergency department suggesting that it could not be used as a triage tool . However, Lime A with his colleagues found that PPI is significantly lower in critically ill patients with a peripheral perfusion alteration(0.7 vs 2.3, p < 0.01) Another study showed that the PPI is altered in septic shock patients, as compared to control subjects in postoperative scheduled surgery. Moreover, in the same study, the PPI was significantly lower in non-survivors. With a 0.20 cutoff value, PPI was predictive of ICU mortality with an AUC of 84% (69-96), a sensitivity of 65% and a specificity of 92%.
- Conditions
- Sepsis, Perfusion Index, Vasopressor
- Being tested
- Vasoconstrictor Agents
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vasoconstrictor AgentsDrug
vasopressor agents will be started in patients with sepsis who will not improved using the resuscitation fluids
| Study group | Role | What they receive |
|---|---|---|
| vasopressor | Not described Receives: Drug: Vasoconstrictor Agents | |
| no vasopressor | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
PI (perfusion index ) variable will be measured at the start of resuscitation and at the start of vasopressor therapy
PI will be measured at the start of resuscitation after volume resuscitation and before the use of vasopressor then will be measured 6 hours after resuscitation
Measured: PI variable will be recorded at baseline( T0 )and after 5 minutes from starting of resuscitation (T5) and then 6 hours thereafter for 24 hours
Secondary outcomes (8)
Mean arterial Blood pressure
mean arterial blood pressure in mmHg
Measured: Baseline (T0 ) ,5 miutes after initial fluid resuscitation (T5) and 6 hours thereafter (T6) for 24 hours
Heart rate (HR)
in beat per minute (bpm)
Measured: Baseline (T0 ) ,5 miutes after initial fluid resuscitation (T5) and 6 hours thereafter (T6) for 24 hours
The central venous-arterial blood carbon dioxide partial pressure difference (Pv-aCO2)
The central venous-arterial blood carbon dioxide partial pressure difference (Pv-aCO2) will be calculated as the difference between the partial pressures of central venous carbon dioxide (PcvCO2) and arterial carbon dioxide (PaCO2).
Measured: Baseline (T0 ) ,5 minutes after initial fluid resuscitation (T5) and 6 hours thereafter (T6) for 24 hours
arterial lactate concentration
Measured: Baseline (T0 ) ,5 minutes after initial fluid resuscitation (T5) and 6 hours thereafter (T6) for 24 hours
ScvO2 (central venous oxygen saturation )
ScvO2 will be calculated from a sample taken from the central venous catheter.
Measured: Baseline (T0 ) ,5 minutes after initial fluid resuscitation (T5) and 6 hours thereafter (T6) for 24 hours
APACHE Score
APACHE score stands for acute physiology and chronic health evaluation.APACHE scores use clinical, physiological and laboratory data observed at admission and during the first 24 hours after ICU admission. This is in order to estimate a given patient's severity of illness by providing a severity score and a probability of hospital death .It consists of twelve acute physiologic variables, age, and chronic health status. The APACHE II score is determined by totalling points from these three sections, resulting in a total score between 0 and 71 points (0 is low risk and 71 is the high risk )
Measured: first 24 hours
SOFA score
SOFA score stands for Sequential Organ Failure Assessment .it is a composite score based on the degree of dysfunction in six organ systems-respiratory, coagulation, hepatic, cardiovascular, central nervous system, and renal . Each organ dysfunction scores from 0 to 4, with increasing scores reflecting more abnormal physiology and biochemistry or an increasing degree of intervention Score ranges from 0 (best) to 24 (worst) points
Measured: 48 hours
Mortality
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start1 Aug 2024
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nancy shaker shaker elhusseiny, Ain Shams University
- Investigators
- Nancy shaker ass,lecurer, Principal investigator, faculty of medicine, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06860438
- Sponsor's protocol ID
- FMASU MD12/2024
- Status last verified
- Feb 2025
- First submitted
- 17 Feb 2025
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Perfusion Index Indicate the Need of Vasopressor in ICU Patients with Sepsis and Septic Shock, Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06860438
- Acronym / sponsor ID
- FMASU MD12/2024
- Conditions
- Sepsis, Perfusion Index, Vasopressor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 6 Mar 2025 (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.
In this thesis we will use the current state of knowledge that PI can provide a reliable information about the state of peripheral microcirculation during the state of sepsis and septic shock in ICU patients and that can interfere with the timing of starting vasopressor treatment in sepsis and septic shock
Detailed description
Septic shock is the leading cause of death worldwide, with in-hospital and intensive care mortality rates of 11.9% to 47.2%, depending on the setting and severity of the disease .
Endothelial dysfunction is a key element in sepsis pathophysiology. It is responsible for the sepsis-induced hypotension. So the essential step in the management of sepsis is to increase systemic and regional/microcirculatory flow. Increasing arterial blood pressure (ABP) with vasopressors when patients are hypotensive is used to improve the input pressure driving organ perfusion .
Experts' recommendations currently position norepinephrine (NE) as the first-line vasopressor in septic shock. Its early administration may allow achieving the initial mean arterial pressure (MAP) target faster and reducing the risk of fluid overload. However , controversies still exist on some issues such as, whether very early use of norepinephrine (NE) could improve outcome, whether individualized target of mean arterial pressure (MAP) should be applied . Perfusion index (PI) is a reliable noninvasive indicator of peripheral perfusion derived from the photoelectric plethysmographic (PPG) signal of a pulse oximetry . The perfusion index (PI) represents the ratio of pulsatile on non-pulsatile light absorbance or reflectance of the PPG signal. PI determinants are complex and interlinked, involving and reflecting the interaction between peripheral and central hemodynamic characteristics, such as vascular tone and stroke volume. Recently, several studies have shed light on the interesting performances of this variable, especially assessing hemodynamic monitoring in anesthesia, perioperative and intensive care.
Peripheral perfusion index is an early predictor of central hypovolemia. In a prospective observational study in an emergency department, PPI was not significantly different between patients admitted to the hospital and patients discharged from the emergency department suggesting that it could not be used as a triage tool . However, Lime A with his colleagues found that PPI is significantly lower in critically ill patients with a peripheral perfusion alteration(0.7 vs 2.3, p < 0.01) Another study showed that the PPI is altered in septic shock patients, as compared to control subjects in postoperative scheduled surgery. Moreover, in the same study, the PPI was significantly lower in non-survivors. With a 0.20 cutoff value, PPI was predictive of ICU mortality with an AUC of 84% (69-96), a sensitivity of 65% and a specificity of 92%.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vasopressor | – | Drug: Vasoconstrictor Agents |
| no vasopressor | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU patients with sepsis
Key inclusion criteria (1 listed)
- All ICU patients with clinically suspected sepsis and septic shock ( signs include fever hypotension oliguria and confusion combined with culture results showing infection .Septic shock is a subset of sepsis involves persistent hypotension (mean arterial pressure ≥ 65 mm Hg, and a serum lactate level > 18 mg/dL [2 mmol/L)not responding to fluid resuscitation ) .
Key exclusion criteria (6 listed)
- Pregnant females
- Patients on vasopressor or positive inotropic drugs
- Patients with hypothermia (defined as central temperature <35°C).
- Patient with impairment of upper extremity circulation,(such as those who underwent radial artery harvesting for coronary artery bypass grafting or had suspected occlusion of the radial artery prior to surgery,)
- Patients had undergone an operation that involved the large arteries of the aortic arch.
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 |
|---|---|---|
| Vasoconstrictor Agentsvasopressor agents will be started in patients with sepsis who will not improved using the resuscitation fluids | Drug | vasopressor |
Primary outcome
PI (perfusion index ) variable will be measured at the start of resuscitation and at the start of vasopressor therapy
Time frame: PI variable will be recorded at baseline( T0 )and after 5 minutes from starting of resuscitation (T5) and then 6 hours thereafter for 24 hours
PI will be measured at the start of resuscitation after volume resuscitation and before the use of vasopressor then will be measured 6 hours after resuscitation
8 secondary outcomes
Mean arterial Blood pressure
Time frame: Baseline (T0 ) ,5 miutes after initial fluid resuscitation (T5) and 6 hours thereafter (T6) for 24 hours
Heart rate (HR)
Time frame: Baseline (T0 ) ,5 miutes after initial fluid resuscitation (T5) and 6 hours thereafter (T6) for 24 hours
The central venous-arterial blood carbon dioxide partial pressure difference (Pv-aCO2)
Time frame: Baseline (T0 ) ,5 minutes after initial fluid resuscitation (T5) and 6 hours thereafter (T6) for 24 hours
arterial lactate concentration
Time frame: Baseline (T0 ) ,5 minutes after initial fluid resuscitation (T5) and 6 hours thereafter (T6) for 24 hours
ScvO2 (central venous oxygen saturation )
Time frame: Baseline (T0 ) ,5 minutes after initial fluid resuscitation (T5) and 6 hours thereafter (T6) for 24 hours
APACHE Score
Time frame: first 24 hours
SOFA score
Time frame: 48 hours
Mortality
Time frame: 28 days
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 6 Mar 2025.
- Individual participant dataSharing planned: No
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Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
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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.
Nancy shaker ass,lecurer principal investigator
faculty of medicine, Ain Shams 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 and Perfusion Index, run by Ain Shams 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 1 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: looking for participants now, as of the sponsor's last update on 6 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?
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 Nancy Shaker ass.lecturer (00201067003436, nancy.shaker@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PI (perfusion index ) variable will be measured at the start of resuscitation and at the start of vasopressor therapy (time frame: PI variable will be recorded at baseline( T0 )and after 5 minutes from starting of resuscitation (T5) and then 6 hours thereafter for 24 hours). 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 6 Mar 2025.