Septic Shock / Hypocalcemia / Sepsis · Observational Study

Ionized Calcium as a Severity Marker in Septic Shock Patients

ClinicalTrials.gov · September 10, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a planned observational study registered to evaluate whether ionized calcium levels at ICU admission correlate with severity scores (SOFA, APACHE II) and outcomes in sepsis or septic shock. No results are yet available in this registry record; the study has not begun recruitment.

What was studied

Observational. Sepsis, Septic Shock, Hypocalcemia; age from 18 Years. Intervention: Sepsis and Septic Shock Cohort. n = 160. Assiut University (Egypt), location inferred from lead sponsor; no international sites stated.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a clinical trial registry record for a planned observational study with no results posted; enrollment has not yet begun, so no evidence on the research question exists.

Study design

As stated by the source record.

MethodsCohort model. Prospective time perspective. Primary outcome measure: Correlation Between Admission Ionized Calcium Levels and SOFA Score (assessed at Baseline)

DesignObservational

PopulationSepsis, Septic Shock, Hypocalcemia; age from 18 Years

Sample size160

InterventionSepsis and Septic Shock Cohort

SettingAssiut University (Egypt), location inferred from lead sponsor; no international sites stated

Reported figures

Quoted from the source exactly as published.

Planned enrollment160

Primary outcome measureCorrelation between admission ionized calcium levels and SOFA score (baseline)

Secondary outcomes28-day mortality, length of ICU stay, need for mechanical ventilation or vasopressor medications

Caveats

This is a registry record only; no results are reported or available for clinical interpretation.
Observational design cannot establish causation or guide intervention; results at best can suggest association.
Study has not yet begun recruitment (status: NOT_YET_RECRUITING); no data exist to evaluate.
Effect sizes, confidence intervals, p-values, and outcome frequencies are not reported because the study is not yet active.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

limited

Observational design without randomization or control arm limits causal inference.

Directness

strong

Directly examines ionized calcium as a severity marker in septic shock patients at admission.

Consistency

insufficient

No results reported; consistency cannot be assessed from a registry record.

Risk of bias

insufficient

Study not yet recruiting; conduct and bias risk unknown until execution and results.

Sample adequacy

moderate

Planned enrollment 160 participants; adequacy depends on effect size assumptions not stated.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07812051). This is a study registration, not published results. Lead sponsor: Assiut University. Recruitment status: NOT_YET_RECRUITING. Study type: OBSERVATIONAL. Enrollment: 160 participants (ESTIMATED). Conditions: Sepsis, Septic Shock, Hypocalcemia. Primary outcome measures: Correlation Between Admission Ionized Calcium Levels and SOFA Score , Baseline. Brief 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Septic ShockAssiut UniversityHypocalcemiaNCT07812051Sepsis