Ionized Calcium as a Severity Marker in Septic Shock Patients

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssiut University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

160 Participants
are grouped into 1 trial group
Group A: Sepsis and Septic Shock Cohort

Trial outcomes

Primary outcomes

1

Correlation Between Admission Ionized Calcium Levels and SOFA Score

Correlation between baseline ionized calcium levels and disease severity assessed by the Sequential Organ Failure Assessment (SOFA) score. Scores range from 0 to 24, where higher scores indicate greater organ failure.

Time frame
Baseline

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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