Septic ShockNCT07330908
Different Norepinephrine Doses on Accuracy of Peripheral Perfusion Index in Predicting Tissue Perfusion in Septic Shock Patients
A study testing Group I: Patients will receive norepinephrine <0.15 µg/kg/min and Group II: Patients will receive norepinephrine ≥ 0.15 µg/kg/min in people with Septic Shock and Peripheral Perfusion Index, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to evaluate the impact of different norepinephrine doses on the accuracy of the peripheral perfusion index in predicting tissue perfusion in septic shock patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Septic Shock, Peripheral Perfusion Index
- What is being tested?
- Group I: Patients will receive norepinephrine <0.15 µg/kg/min and Group II: Patients will receive norepinephrine ≥ 0.15 µg/kg/min
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Oct 2024to 30 Mar 2025
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 65 years.
- Both sexes.
- Septic shock patients requiring norepinephrine infusion at dose <0.25 µg/kg/min to achieve mean arterial pressure (Mean arterial blood pressure ≥ 65 mm Hg).
Who cannot join
- Patients fail to achieve Mean arterial blood ≥ 65 mm Hg or need norepinephrine dose ≥0.25 µg /kg/min.
- Pregnancy.
- Diabetes mellitus.
- Tissue edema.
- Respiratory diseases affecting gas exchange, such as asthma and Chronic Obstructive Pulmonary Disease.
- Sever hypoxemia or hypercarbia.
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- Core temperature < 36 ᴼc.
- Body mass index ≥35 kg/m2
- Cardiovascular diseases and pulmonary edema
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Different Norepinephrine Doses on Accuracy of Peripheral Perfusion Index in Predicting Tissue Perfusion in Septic Shock Patients
This study aims to evaluate the impact of different norepinephrine doses on the accuracy of the peripheral perfusion index in predicting tissue perfusion in septic shock patients.
Primary outcome:
- Correlation between peripheral perfusion index
Secondary outcomes:
- Peripheral perfusion index accuracy to predict the tissue perfusion .
- Peripheral perfusion index accuracy to predict mortality.
Read the detailed description
Septic shock is a common cause of intensive care unit admission and one of the major causes of death among intensive care unit inpatients.
It is a complex critical condition associated with a reported mortality rate of up to 30% to 40%.
. It is the most severe form of sepsis with concomitant hemodynamic failure and immune, inflammatory, and metabolic disorders. The resulting circulatory shock finally leads to an alteration of tissue perfusion, causing organ failures and associated poor outcomes.
An essential step in managing patients with septic shock is to increase systemic and regional/microcirculatory flow. Increasing arterial blood pressure with vasopressors when patients are hypotensive improves the input pressure that drives organ perfusion. Therefore, maintaining organ perfusion in the time course of septic shock is a fundamental goal.
Norepinephrine is a commonly used vasopressor in the management of septic shock. It increases vascular tone and blood pressure, thereby improving systemic perfusion. However, excessive norepinephrine dosing is associated with the risk of extreme vasoconstriction, tissue hypoperfusion, and increased mortality. Peripheral and regional tissue perfusion in patients with septic shock have been extensively studied over the last decade. Indeed, several authors have emphasized the potential benefits of monitoring microcirculatory and regional perfusion parameters to better guide the resuscitation of these patients and give a prognosis. The peripheral perfusion index ,which is defined as the ratio of the pulsatile to non-pulsatile component of the pulse oximetry plethysmograph (peripheral perfusion index = pulsatile signal/ non-pulsatile signal), is used as a simple and accurate indicator of the pulsation intensity of peripheral arterioles .
We hypothesize that peripheral perfusion index could accurately predict tissue perfusion at different doses of norepinephrine in septic shock patients. This study aims to evaluate the impact of different norepinephrine doses on the accuracy of the peripheral perfusion index in predicting tissue perfusion in septic shock patients.
Primary outcome:
- Correlation between peripheral perfusion index
Secondary outcomes:
- Peripheral perfusion index accuracy to predict the tissue perfusion .
- Peripheral perfusion index accuracy to predict mortality.
- Conditions
- Septic Shock, Peripheral Perfusion Index
- Being tested
- Group I: Patients will receive norepinephrine <0.15 µg/kg/min, Group II: Patients will receive norepinephrine ≥ 0.15 µg/kg/min
- Keywords
- Norepinephrine, Peripheral Perfusion Index, Septic Shock, Tissue Perfusion
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group I: Patients will receive norepinephrine <0.15 µg/kg/minDrug
Patients will receive norepinephrine <0.15 µg/kg/min
Group II: Patients will receive norepinephrine ≥ 0.15 µg/kg/minDrug
Patients will receive norepinephrine ≥ 0.15 µg/kg/min
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Patients will receive norepinephrine <0.15 µg/kg/minute Receives: Drug: Group I: Patients will receive norepinephrine <0.15 µg/kg/min |
| Group II | Experimental | Patients will receive norepinephrine ≥ 0.15 µg/kg/minutes Receives: Drug: Group II: Patients will receive norepinephrine ≥ 0.15 µg/kg/min |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between Peripheral Perfusion Index and ( Central venous oxygen saturation , and lactate clearance).
Measured: Before initiation of vasopressor therapy, 5 minutes, 30 minutes, 1 hour, 2 hours, and 6 hours post-initiation of vasopressor therapy
Secondary outcomes (1)
Mean arterial blood pressure
Measured: Before the initiation of vasopressor therapy, 5 minutes, 30 minutes,, 1 hour, 2 hours, and 6 hours after the initiation of vasopressor therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start30 Oct 2024
- Primary completion30 Mar 2025
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Abdelghafar Elbaghdady, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07330908
- Sponsor's protocol ID
- 36264MS735/11/24
- Status last verified
- Oct 2024
- First submitted
- 28 Dec 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It will be provided when required
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Different Norepinephrine Doses on Accuracy of Peripheral Perfusion Index in Predicting Tissue Perfusion in Septic Shock Patients
- ClinicalTrials.gov ID
- NCT07330908
- Acronym / sponsor ID
- 36264MS735/11/24
- Conditions
- Septic Shock, Peripheral Perfusion Index
- Keywords
- Norepinephrine, Peripheral Perfusion Index, Septic Shock, Tissue Perfusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 30 Oct 2024 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 9 Jan 2026 (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.
This study aims to evaluate the impact of different norepinephrine doses on the accuracy of the peripheral perfusion index in predicting tissue perfusion in septic shock patients.
Primary outcome:
- Correlation between peripheral perfusion index
Secondary outcomes:
- Peripheral perfusion index accuracy to predict the tissue perfusion .
- Peripheral perfusion index accuracy to predict mortality.
Detailed description
Septic shock is a common cause of intensive care unit admission and one of the major causes of death among intensive care unit inpatients.
It is a complex critical condition associated with a reported mortality rate of up to 30% to 40%.
. It is the most severe form of sepsis with concomitant hemodynamic failure and immune, inflammatory, and metabolic disorders. The resulting circulatory shock finally leads to an alteration of tissue perfusion, causing organ failures and associated poor outcomes.
An essential step in managing patients with septic shock is to increase systemic and regional/microcirculatory flow. Increasing arterial blood pressure with vasopressors when patients are hypotensive improves the input pressure that drives organ perfusion. Therefore, maintaining organ perfusion in the time course of septic shock is a fundamental goal.
Norepinephrine is a commonly used vasopressor in the management of septic shock. It increases vascular tone and blood pressure, thereby improving systemic perfusion. However, excessive norepinephrine dosing is associated with the risk of extreme vasoconstriction, tissue hypoperfusion, and increased mortality. Peripheral and regional tissue perfusion in patients with septic shock have been extensively studied over the last decade. Indeed, several authors have emphasized the potential benefits of monitoring microcirculatory and regional perfusion parameters to better guide the resuscitation of these patients and give a prognosis. The peripheral perfusion index ,which is defined as the ratio of the pulsatile to non-pulsatile component of the pulse oximetry plethysmograph (peripheral perfusion index = pulsatile signal/ non-pulsatile signal), is used as a simple and accurate indicator of the pulsation intensity of peripheral arterioles .
We hypothesize that peripheral perfusion index could accurately predict tissue perfusion at different doses of norepinephrine in septic shock patients. This study aims to evaluate the impact of different norepinephrine doses on the accuracy of the peripheral perfusion index in predicting tissue perfusion in septic shock patients.
Primary outcome:
- Correlation between peripheral perfusion index
Secondary outcomes:
- Peripheral perfusion index accuracy to predict the tissue perfusion .
- Peripheral perfusion index accuracy to predict mortality.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Drug: Group I: Patients will receive norepinephrine <0.15 µg/kg/minPatients will receive norepinephrine <0.15 µg/kg/minute |
| Group II | Experimental | Drug: Group II: Patients will receive norepinephrine ≥ 0.15 µg/kg/minPatients will receive norepinephrine ≥ 0.15 µg/kg/minutes |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 to 65 years.
- Both sexes.
- Septic shock patients requiring norepinephrine infusion at dose <0.25 µg/kg/min to achieve mean arterial pressure (Mean arterial blood pressure ≥ 65 mm Hg).
Key exclusion criteria (9 listed)
- Patients fail to achieve Mean arterial blood ≥ 65 mm Hg or need norepinephrine dose ≥0.25 µg /kg/min.
- Pregnancy.
- Diabetes mellitus.
- Tissue edema.
- Respiratory diseases affecting gas exchange, such as asthma and Chronic Obstructive Pulmonary Disease.
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 |
|---|---|---|
| Group I: Patients will receive norepinephrine <0.15 µg/kg/minPatients will receive norepinephrine <0.15 µg/kg/min | Drug | Group I |
| Group II: Patients will receive norepinephrine ≥ 0.15 µg/kg/minPatients will receive norepinephrine ≥ 0.15 µg/kg/min | Drug | Group II |
Primary outcome
Correlation between Peripheral Perfusion Index and ( Central venous oxygen saturation , and lactate clearance).
Time frame: Before initiation of vasopressor therapy, 5 minutes, 30 minutes, 1 hour, 2 hours, and 6 hours post-initiation of vasopressor therapy
1 secondary outcome
Mean arterial blood pressure
Time frame: Before the initiation of vasopressor therapy, 5 minutes, 30 minutes,, 1 hour, 2 hours, and 6 hours after the initiation of vasopressor therapy.
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 9 Jan 2026.
- Individual participant dataSharing planned: Yes. It will be provided when required
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group I: Patients will receive norepinephrine <0.15 µg/kg/min and Group II: Patients will receive norepinephrine ≥ 0.15 µg/kg/min in people with Septic Shock and Peripheral Perfusion Index, run by Tanta 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 3 inclusion and 9 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 9 Jan 2026. 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?
Correlation between Peripheral Perfusion Index and ( Central venous oxygen saturation , and lactate clearance). (time frame: Before initiation of vasopressor therapy, 5 minutes, 30 minutes, 1 hour, 2 hours, and 6 hours post-initiation of vasopressor therapy). 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 9 Jan 2026.