ClinicalTrials.gg
Not yet recruitingNCT07812051Updated Sep 10, 2026

Ionized Calcium as a Severity Marker in Septic Shock Patients

An observational study in Sepsis, Septic Shock and Hypocalcemia, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.

Primary conditionShock, SepticRegistry: SepsisReclassifiedWhy we changed it
Registry
Sepsis — the first condition term the registry derived for this study.
ClinicalTrials.gg
Shock, Septic
Why
  1. The study's listed conditions name Shock, Septic, a narrower term within Sepsis.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Assiut University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
160
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Sepsis
  • Septic Shock
  • Hypocalcemia

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Keywords

  • Ionized Calcium
  • SOFA Score
  • APACHE II Score
  • Intensive Care Units
  • Mortality
  • Critical Illness
  • Biomarkers
03

In context

Shock, Septic Reclassified

1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.

This study's planned enrollment of 160 is above the median of 108 across 406 observational studies indexed under Shock, Septic.

Browse Shock, Septic studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Compared within Shock, Septic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Sepsis. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study 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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
160 participants (estimated)
Patient registry
No

Groups and cohorts

  • Sepsis and Septic Shock Cohort

    Adult patients (aged 18 years or older) diagnosed with sepsis or septic shock according to the Sepsis-3 definitions and admitted to the intensive care unit (ICU) within 24 hours of presentation. Patients receive standard, evidence-based supportive care. Ionized calcium levels along with arterial blood gases, organ failure scores (SOFA and APACHE II), and baseline laboratory parameters are assessed upon admission and monitored at 24 and 48 hours to evaluate prognostic outcomes.

06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Oct 2027, 12 months later.

Of 189 non-industry observational studies under Shock, Septic, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 47. This study's planned 12 months is below that.

Counting every sponsor, half of 202 studies reached it within 25 months; a quarter within 12 and three quarters within 47.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 4, 2026
First posted
Sep 10, 2026
StartEst.
Oct 2026
Primary completionEst.
Oct 2027
CompletionEst.
Nov 2027
Last update
Sep 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07812051
Lead sponsor
Assiut University
Responsible party
Mina Saad Seddik Danial (Resident, Assiut University) — Principal investigator
First posted
Sep 10, 2026
Start date
Oct 2026 (estimated)
Primary completion
Oct 2027 (estimated)
Completion
Nov 2027 (estimated)
Last update
Sep 10, 2026
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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