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.
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.
Show all 10Show fewer
- 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 group | Role | What they receive |
|---|---|---|
| study group | Patients 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.
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.
- First posted31 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionOct 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
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelmouiz Anwer Abdelnazeer Yasien, Assiut University
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
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation of Serum Phosphate Level to the Duration of Mechanical Ventilation in Patient With Sepsis
- ClinicalTrials.gov ID
- NCT07739251
- Acronym / sponsor ID
- phosphate level MV Sepsis
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 31 Jul 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 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.
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 .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | –Patients with sepsis or meeting the diagnostic criteria of septic shock |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with sepsis or meeting the diagnostic criteria of septic shock
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (10 listed)
- - 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.
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
frequency of hypophostaemia
Time frame: 4 week
frequency of hypophostaemia among critically ill patients with sepsis
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 31 Jul 2026.
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
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, 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.