NCT07739251

Brief 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. 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 .

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
13mo left

Started Sep 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 31, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

July 31, 2026

Status Verified

July 1, 2026

Enrollment Period

1 year

First QC Date

July 28, 2026

Last Update Submit

July 28, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • frequency of hypophostaemia

    frequency of hypophostaemia among critically ill patients with sepsis

    4 week

Study Arms (1)

study group

Patients with sepsis or meeting the diagnostic criteria of septic shock

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with sepsis or meeting the diagnostic criteria of septic shock

You may qualify if:

  • 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

You may not qualify if:

  • \- 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.
  • Patients with diabetic ketoacidosis.
  • Patients with burns, major trauma, or postoperative ICU admission.
  • Pregnant patients.
  • Refusal to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
residant doctor at Assiut university hospital

Study Record Dates

First Submitted

July 28, 2026

First Posted

July 31, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

July 31, 2026

Record last verified: 2026-07