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Assessment of Core-to-Big-Toe Temperature Gradient (ΔT) as a Non-Invasive Marker of Peripheral Perfusion in Adult Patients With Septic Shock
Sponsor study identifier
observational
54
0 countries
N/A
Study Start
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
November 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 7, 2026
Actual (reported)October 13, 2026
Actual (reported)November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Baseline and Hour 12
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).
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.
First Submitted
October 7, 2026
First Posted
October 13, 2026
Study Start
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
November 2027
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 13, 2026
Record last verified: 2026-10
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