An observational study in Septic Shock and Sepsis, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Assiut University · Observational
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.
890 studies on the registry are indexed under Shock, Septic; 210 are open to participants now.
This study's planned enrollment of 54 is below the median of 100 across 309 observational studies indexed under Shock, Septic.
Browse Shock, Septic studies →Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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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.
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Exclusion Criteria:
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).
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.
Time frame: Baseline and Hour 12
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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