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SepsisNCT07739251

Relation of Serum Phosphate Level to the Duration of Mechanical Ventilation in Patient With Sepsis

An observational study of Sepsis, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection. Septic shock is a subset of sepsis in which underlying circulatory and cellular/metabolic abnormalities are profound enough to substantially increase mortality. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sepsis
How many people
110 participants
Where
No sites listed yet
Study dates
Sep 2026to Oct 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
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with sepsis or meeting the diagnostic criteria of septic shock

Who may be able to join

  • Patients with sepsis or meeting the diagnostic criteria of septic shock
  • Clinical criteria of septic shock
  • A patient with sepsis who, despite adequate fluid resuscitation, has:
  • A vasopressor requirement to maintain a mean arterial pressure (MAP) ≥ 65 mmHg, and
  • A serum lactate level > 2 mmol/L (18 mg/dL)
  • Age more than 18 years old

Who cannot join

  • - Age less than 18 years.
  • ICU stay less than 24 hours.
  • Patients receiving renal replacement therapy before ICU admission.
  • Patients with known parathyroid disorders or metabolic bone disease.
  • Patients receiving phosphate supplements before ICU admission.
  • Patients receiving medications affecting phosphate levels, such as , insulin overdose, or chemotherapy.
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  • Patients with diabetic ketoacidosis.
  • Patients with burns, major trauma, or postoperative ICU admission.
  • Pregnant patients.
  • Refusal to participate in the study.

About this study

Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection.

Septic shock is a subset of sepsis in which underlying circulatory and cellular/metabolic abnormalities are profound enough to substantially increase mortality.

Read more

Septic shock represents the most severe form of sepsis and remains a leading cause of admission to intensive care units (ICUs) worldwide. It is characterized by profound circulatory, cellular, and metabolic abnormalities resulting from a dysregulated host response to infection .

Despite significant advances in antimicrobial therapy, haemodynamic monitoring, organ support, and critical care management, septic shock continues to be associated with high morbidity and mortality. Patients frequently develop multiple organ dysfunction requiring prolonged ICU stay, mechanical ventilation, vasopressors support, and renal replacement therapy .

Identification of modifiable risk factors that influence clinical outcomes remains a major priority in the management of septic shock. Electrolyte disturbances are common among critically ill patients, with hypophosphatemia being one of the most frequently encountered abnormalities .

Serum phosphate plays a vital role in numerous physiological processes, including cellular energy production, adenosine triphosphate (ATP) synthesis, oxygen delivery through regulation of 2,3-diphosphoglycerate, membrane integrity, intracellular signaling, acid-base balance, and neuromuscular function .

In septic shock, hypophosphatemia may develop because of intracellular phosphate redistribution induced by catecholamine release, respiratory alkalosis, insulin administration, aggressive fluid resuscitation, renal phosphate wasting, malnutrition, and continuous renal replacement therapy. Consequently, phosphate depletion may occur early during the course of critical illness and may persist despite standard supportive treatment .

Hypophosphatemia has important clinical implications in critically ill patients. Severe phosphate deficiency impairs diaphragmatic contractility, respiratory muscle strength, myocardial performance, leukocyte function, and skeletal muscle metabolism. These abnormalities may delay liberation from mechanical ventilation, impair oxygen delivery, increase susceptibility to infection, prolong ICU stay, and adversely affect patient outcomes .

Several studies have suggested that hypophosphatemia is associated with increased disease severity, prolonged mechanical ventilation, and higher mortality in critically ill patients, although the available evidence remains inconsistent, particularly among patients with septic shock.

Mechanical ventilation is frequently required in septic shock because of respiratory failure, acute respiratory distress syndrome, impaired consciousness, or hemodynamic instability. Successful weaning from mechanical ventilation depends largely on adequate respiratory muscle function and sufficient cellular energy production, both of which require normal phosphate homeostasis .

Hypophosphatemia may reduce diaphragmatic strength and impair respiratory muscle endurance, resulting in prolonged ventilator dependence and delayed weaning. Therefore, early recognition and correction of phosphate deficiency may represent a potentially modifiable factor capable of improving respiratory outcomes in critically ill patients .

Although phosphate disturbances are well recognized in the ICU, data regarding the incidence of hypophosphatemia upon ICU admission and its relationship with the duration of mechanical ventilation in patients with septic shock remain limited, particularly in developing countries. Understanding this relationship may facilitate early identification of high-risk patients, optimize electrolyte management, improve ventilator weaning strategies, and ultimately reduce ICU morbidity and healthcare costs .

Conditions
Sepsis
Medical subject headings
Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07739251
Study groupRoleWhat they receive
study groupPatients with sepsis or meeting the diagnostic criteria of septic shock

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. frequency of hypophostaemia

    frequency of hypophostaemia among critically ill patients with sepsis

    Measured: 4 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionSep 2027 (estimated)
  4. Study completionOct 2027 (estimated)

Resources

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
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07739251
Sponsor's protocol ID
phosphate level MV Sepsis
Status last verified
Jul 2026
First submitted
28 Jul 2026
Last updated
31 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Sepsis, 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 6 inclusion and 10 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 31 Jul 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?

frequency of hypophostaemia (time frame: 4 week). 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 31 Jul 2026.

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