SepsisNCT07812051
Ionized Calcium as a Severity Marker in Septic Shock Patients
An observational study of Sepsis and Septic Shock, run by Assiut University.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Septic Shock, Hypocalcemia
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
About this study
Official title: Evaluation of the Prognostic Value of Changes in Ionized Calcium as a Severity Marker in Septic Shock Patients in the Intensive Care Unit
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.
- Conditions
- Sepsis, Septic Shock, Hypocalcemia
- Keywords
- Ionized Calcium, SOFA Score, APACHE II Score, Intensive Care Units, Mortality, Critical Illness, Biomarkers
- Medical subject headings
- Sepsis, Shock, Septic, Hypocalcemia, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Saad Seddik Danial, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07812051
- Sponsor's protocol ID
- Ionized Calcium in Sepsis ICU
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Prognostic Value of Changes in Ionized Calcium as a Severity Marker in Septic Shock Patients in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT07812051
- Acronym / sponsor ID
- Ionized Calcium in Sepsis ICU
- Conditions
- Sepsis, Septic Shock, Hypocalcemia
- Keywords
- Ionized Calcium, SOFA Score, APACHE II Score, Intensive Care Units, Mortality, Critical Illness, Biomarkers
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation Between Admission Ionized Calcium Levels and SOFA Score
Time frame: Baseline
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Septic Shock, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation Between Admission Ionized Calcium Levels and SOFA Score (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.