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Evaluation of the prognostic value of changes in ionized calcium as a severity marker in septic shock patients in the intensive care unit

NCT ID NCT07812051

NEW Sponsor: Assiut University Source: ClinicalTrials.gov ↗

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First seen Sep 10, 2026 · Last updated Sep 10, 2026

Summary

Sepsis is a serious condition where the body has an extreme, dysregulated response to an infection, often leading to life-threatening organ dysfunction. Low levels of ionized calcium (the active, free form of calcium in the blood) are common in critically ill patients admitted to intensive care units (ICUs). While established clinical scoring systems like the Sequential Organ Failure Assessment (SOFA) and Acute Physiology and Chronic Health Evaluation II (APACHE II) help assess illness severity, there is a continuous need for rapid, cost-effective biological markers that can be measured immediately at the bedside using routine blood gas analyzers. The primary purpose of this observational study is to evaluate whether ionized calcium levels measured upon admission to the ICU can serve as an early marker of disease severity and outcome in adult patients diagnosed with sepsis or septic shock. Adult participants diagnosed with sepsis or septic shock who are admitted to the ICU will receive standard medical care. Routine arterial or venous blood samples will be analyzed at admission to measure ionized calcium and other standard laboratory markers. Researchers will correlate these calcium levels with baseline illness severity scores (SOFA and APACHE II) and evaluate patient outcomes, including 28-day mortality, length of ICU stay, and the need for mechanical ventilation or vasopressor medications.

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Study facts

What this study's own registry entry says, in plain language.

Participants

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adult critically ill patients (aged 18 years or older) admitted to the intensive care units (ICUs) at Assiut University Hospitals who are diagnosed with sepsis or septic shock according to the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) criteria within 24 hours of hospital presentation.

Ages

18 years and older

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adult patients aged 18 years or older * Diagnosed with sepsis or septic shock according to the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) * Admission to the intensive care unit (ICU) within 24 hours of presentation Exclusion Criteria: * Known pre-existing disorders of calcium or parathyroid metabolism (e.g., chronic hypoparathyroidism, hyperparathyroidism) * Severe chronic kidney disease (CKD stage 4 or 5) or end-stage renal disease on dialysis * Patients receiving active intravenous calcium, bisphosphonates, or vitamin D supplementation within 48 hours prior to admission * Massive blood transfusion (more than 4 units of packed red blood cells) within 6 hours of admission (due to citrate-induced hypocalcemia)

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Conditions

The condition(s) this trial relates to.

autosomal dominant hypocalcemia Critical Illness Hypocalcemia infectious disease with sepsis Sepsis toxic shock syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypocalcemia Sepsis Septic shock

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