Septic ShockNCT07871305
Core-to-Big-Toe Temperature Gradient as a Marker of Peripheral Perfusion in Adult Patients With Septic Shock
An observational study of Septic Shock and Sepsis, run by Assiut University.
Trial summary
Septic shock is a life-threatening condition caused by severe infection that leads to dangerously low blood pressure and impaired blood flow to body tissues and organs. In the intensive care unit (ICU), restoring adequate tissue perfusion (blood flow) is essential during resuscitation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock, Sepsis
- Type of treatment
- Injection or infusion
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Dec 2027
- 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
- Adult, Older adult
Study population: Adult patients aged 18 years or older admitted to the Intensive Care Units (ICUs) of Assiut University Hospitals with a confirmed diagnosis of septic shock according to the Sepsis-3 consensus criteria. Eligible patients present with suspected or documented infection, persistent hypotension requiring vasopressor support to maintain a mean arterial pressure (MAP) ≥ 65 mmHg, and a serum lactate level > 2 mmol/L despite initial fluid resuscitation with at least 30 mL/kg of intravenous crystalloids within the first 3 hours. Enrolled individuals are recruited during the initial resuscitation phase upon ICU admission.
Who may be able to join
- Adult patients aged 18 years or older.
- ICU admission with a confirmed diagnosis of septic shock according to Sepsis-3 criteria (suspected or documented infection, persistent hypotension requiring vasopressors to maintain MAP ≥ 65 mmHg, and serum lactate > 2 mmol/L despite initial fluid resuscitation with at least 30 mL/kg of IV crystalloids within the first 3 hours).
- Enrollment during the initial resuscitation phase following ICU admission.
- Feasibility of obtaining serial temperature and hemodynamic measurements at the predefined study time points (baseline [T0], 6 hours [T6], and 12 hours [T12]).
- Written informed consent obtained from the patient or an authorized legal representative.
Who cannot join
- Pre-existing lower-limb peripheral vascular disease (PVD) or critical limb ischemia.
- Major lower-extremity trauma or amputation involving the measurement site.
- Deep vein thrombosis (DVT), active diabetic foot ulcer, severe peripheral edema, or occlusive dressing involving the big toe.
- Localized burns, infection, or severe skin pathology at the big-toe measurement site.
- Direct application of active thermal management devices to the lower limbs that may substantially affect temperature measurements.
- Severe underlying non-septic peripheral vascular or autonomic disorders expected to significantly affect peripheral temperature.
- Patients subjected to prolonged, non-standardized pre-ICU resuscitation exceeding 6 hours in the emergency department or hospital wards prior to ICU admission.
- Refusal or inability to obtain informed consent.
About this study
Official title: Assessment of Core-to-Big-Toe Temperature Gradient (ΔT) as a Non-Invasive Marker of Peripheral Perfusion in Adult Patients With Septic Shock
Septic shock is a life-threatening condition caused by severe infection that leads to dangerously low blood pressure and impaired blood flow to body tissues and organs. In the intensive care unit (ICU), restoring adequate tissue perfusion (blood flow) is essential during resuscitation. While doctors routinely monitor overall blood pressure, microcirculatory blood flow in peripheral tissues, such as the skin of the feet, can remain poor even after general blood pressure targets are reached. The difference between core body temperature and big-toe skin temperature (known as the core-to-big-toe temperature gradient, or ΔT) reflects blood vessel constriction in the extremities. When peripheral blood flow improves, skin temperature rises and this gradient narrows.
This prospective observational study aims to evaluate whether serial measurements of the core-to-big-toe temperature gradient significantly change during the first 12 hours of ICU resuscitation in adult patients presenting with septic shock. The study also examines whether changes in this gradient correlate with standard indicators of clinical recovery, including blood pressure, vasopressor medicine requirements, and blood lactate clearance.
All enrolled participants will receive standard, evidence-based medical care for septic shock in accordance with current international clinical guidelines; study participation will not interfere with, alter, or delay clinical treatment. Non-invasive measurements will be collected at three time points: at ICU admission (Hour 0), at 6 hours, and at 12 hours. These assessments include core body temperature, big-toe skin temperature measured with a calibrated infrared thermometer, finger capillary refill time, routine arterial blood pressure, and arterial blood lactate levels. If effective, this temperature gradient could provide clinicians with a simple, non-invasive, and cost-effective bedside indicator to monitor peripheral perfusion during critical care resuscitation.
- Conditions
- Septic Shock, Sepsis
- Keywords
- Peripheral Perfusion, Skin Temperature, Core-to-Peripheral Temperature Gradient, Big-Toe Temperature, Lactate Clearance, Capillary Refill Time, Hemodynamic Monitoring, Intensive Care Resuscitation
- Medical subject headings
- Shock, Septic, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult Septic Shock Cohort | Adult intensive care unit (ICU) patients aged 18 years or older presenting with septic shock diagnosed according to Sepsis-3 criteria (suspected or documented infection, persistent hypotension requiring vasopressors to maintain MAP ≥ 65 mmHg, and serum lactate > 2 mmol/L despite initial intravenous fluid resuscitation of ≥ 30 mL/kg crystalloids within 3 hours). All patients receive standard-of-care resuscitation per institutional ICU protocols and international guidelines without experimental interventions. Serial observational measurements, including core temperature, big-toe skin temperature, core-to-big-toe temperature gradient (ΔT), capillary refill time (CRT), mean arterial pressure (MAP), serum lactate, and vasopressor dosage, are evaluated at ICU admission baseline (T0), 6 hours (T6), and 12 hours (T12). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Core-to-Big-Toe Temperature Gradient (ΔT) From Baseline to 12 Hours
The core-to-big-toe temperature gradient (ΔT) is calculated as core temperature minus big-toe skin temperature (ΔT = Tcore - Ttoe), expressed in degrees Celsius (°C). Core temperature is measured via standard clinical ICU sensors (esophageal, urinary, or tympanic), and big-toe skin temperature is measured on the plantar surface of the big toe using a calibrated non-contact infrared thermometer (3 to 5 cm distance). Change is assessed as the value at Hour 12 minus the baseline value (Hour 0), where a reduction (negative change) reflects improved peripheral perfusion.
Measured: Baseline and Hour 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionDec 2027 (estimated)
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 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
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Kamal Taha, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07871305
- Sponsor's protocol ID
- Core-to-Toe Gradient in Sepsis
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Core-to-Big-Toe Temperature Gradient (ΔT) as a Non-Invasive Marker of Peripheral Perfusion in Adult Patients With Septic Shock
- ClinicalTrials.gov ID
- NCT07871305
- Acronym / sponsor ID
- Core-to-Toe Gradient in Sepsis
- Conditions
- Septic Shock, Sepsis
- Keywords
- Peripheral Perfusion, Skin Temperature, Core-to-Peripheral Temperature Gradient, Big-Toe Temperature, Lactate Clearance, Capillary Refill Time, Hemodynamic Monitoring, Intensive Care Resuscitation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 Oct 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.
Septic shock is a life-threatening condition caused by severe infection that leads to dangerously low blood pressure and impaired blood flow to body tissues and organs. In the intensive care unit (ICU), restoring adequate tissue perfusion (blood flow) is essential during resuscitation. While doctors routinely monitor overall blood pressure, microcirculatory blood flow in peripheral tissues, such as the skin of the feet, can remain poor even after general blood pressure targets are reached. The difference between core body temperature and big-toe skin temperature (known as the core-to-big-toe temperature gradient, or ΔT) reflects blood vessel constriction in the extremities. When peripheral blood flow improves, skin temperature rises and this gradient narrows.
This prospective observational study aims to evaluate whether serial measurements of the core-to-big-toe temperature gradient significantly change during the first 12 hours of ICU resuscitation in adult patients presenting with septic shock. The study also examines whether changes in this gradient correlate with standard indicators of clinical recovery, including blood pressure, vasopressor medicine requirements, and blood lactate clearance.
All enrolled participants will receive standard, evidence-based medical care for septic shock in accordance with current international clinical guidelines; study participation will not interfere with, alter, or delay clinical treatment. Non-invasive measurements will be collected at three time points: at ICU admission (Hour 0), at 6 hours, and at 12 hours. These assessments include core body temperature, big-toe skin temperature measured with a calibrated infrared thermometer, finger capillary refill time, routine arterial blood pressure, and arterial blood lactate levels. If effective, this temperature gradient could provide clinicians with a simple, non-invasive, and cost-effective bedside indicator to monitor peripheral perfusion during critical care resuscitation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult Septic Shock Cohort | – | –Adult intensive care unit (ICU) patients aged 18 years or older presenting with septic shock diagnosed according to Sepsis-3 criteria (suspected or documented infection, persistent hypotension requiring vasopressors to maintain MAP ≥ 65 mmHg, and serum lactate > 2 mmol/L despite initial intravenous fluid resuscitation of ≥ 30 mL/kg crystalloids within 3 hours). All patients receive standard-of-care resuscitation per institutional ICU protocols and international guidelines without experimental interventions. Serial observational measurements, including core temperature, big-toe skin temperature, core-to-big-toe temperature gradient (ΔT), capillary refill time (CRT), mean arterial pressure (MAP), serum lactate, and vasopressor dosage, are evaluated at ICU admission baseline (T0), 6 hours (T6), and 12 hours (T12). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients aged 18 years or older admitted to the Intensive Care Units (ICUs) of Assiut University Hospitals with a confirmed diagnosis of septic shock according to the Sepsis-3 consensus criteria. Eligible patients present with suspected or documented infection, persistent hypotension requiring vasopressor support to maintain a mean arterial pressure (MAP) ≥ 65 mmHg, and a serum lactate level > 2 mmol/L despite initial fluid resuscitation with at least 30 mL/kg of intravenous crystalloids within the first 3 hours. Enrolled individuals are recruited during the initial resuscitation phase upon ICU admission.
Key inclusion criteria (5 listed)
- Adult patients aged 18 years or older.
- ICU admission with a confirmed diagnosis of septic shock according to Sepsis-3 criteria (suspected or documented infection, persistent hypotension requiring vasopressors to maintain MAP ≥ 65 mmHg, and serum lactate > 2 mmol/L despite initial fluid resuscitation with at least 30 mL/kg of IV crystalloids within the first 3 hours).
- Enrollment during the initial resuscitation phase following ICU admission.
- Feasibility of obtaining serial temperature and hemodynamic measurements at the predefined study time points (baseline [T0], 6 hours [T6], and 12 hours [T12]).
- Written informed consent obtained from the patient or an authorized legal representative.
Key exclusion criteria (8 listed)
- Pre-existing lower-limb peripheral vascular disease (PVD) or critical limb ischemia.
- Major lower-extremity trauma or amputation involving the measurement site.
- Deep vein thrombosis (DVT), active diabetic foot ulcer, severe peripheral edema, or occlusive dressing involving the big toe.
- Localized burns, infection, or severe skin pathology at the big-toe measurement site.
- Direct application of active thermal management devices to the lower limbs that may substantially affect temperature measurements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Core-to-Big-Toe Temperature Gradient (ΔT) From Baseline to 12 Hours
Time frame: Baseline and Hour 12
The core-to-big-toe temperature gradient (ΔT) is calculated as core temperature minus big-toe skin temperature (ΔT = Tcore - Ttoe), expressed in degrees Celsius (°C). Core temperature is measured via standard clinical ICU sensors (esophageal, urinary, or tympanic), and big-toe skin temperature is measured on the plantar surface of the big toe using a calibrated non-contact infrared thermometer (3 to 5 cm distance). Change is assessed as the value at Hour 12 minus the baseline value (Hour 0), where a reduction (negative change) reflects improved peripheral perfusion.
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 13 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Shock and Sepsis, run by Assiut University.
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: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Change in Core-to-Big-Toe Temperature Gradient (ΔT) From Baseline to 12 Hours (time frame: Baseline and Hour 12). 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 13 Oct 2026.