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The current study aimed to determine the incidence of hypophosphatemia (HP) among severe sepsis/septic shock patients admitted to ICU and its impact on morbidity and mortality rates of these patients, and to evaluate the impact of phosphorous supplemental therapy (PST) on such outcomes.Thus, this study will hypothesize that diagnosis and management of HP may be advantageous for reduction of morbidity and mortality rates of septic patients admitted to ICU.
The study will include all patients admitted to ICU with or developing severe sepsis or septic shock within 24-hr after admission to ICU. Patients will be categorized according to at-admission inorganic phosphate (Pi) level into normophosphatemia group and hypophosphatemia group (HP) (mild, moderate and severe HP). All patients will be evaluated using Sequential Organ Failure Assessment (SOFA) and Acute Physiology and Chronic Health Evaluation II score (APACHE II) and blood samples will be collected for ELISA estimation of serum Pi, human C-reactive protein (CRP), L-lactate, CBC picture , serum electrolytes and kidney and liver function tests. Serum Pi level will be re-estimated immediately and 24-hr after full dose administration. Outcomes will include the 28-day ICU morbidity and mortality rates and their relation to HP severity and PST administration.
Patients who will fulfill the inclusion criteria will be selectively divided into two groups according to estimated level of serum Pi: Control group will include patients with serum Pi >2.5 mg/dl and Study group will include patients having serum Pi<2.5 mg/dl and will be further sub-grouped according to severity of HP into mild HP (2-2.5 mg/dl), moderate (1-1.9 mg/dl) or severe (<1 mg/dl).
Central venous catheter will be inserted for all patients enrolled in the study via the jugular or subclavian vein. Then, baseline hemodynamic parameters and central venous pressure (CVP) will be estimated and will be continuously monitored. Arterial blood samples will be obtained anaerobically and collected in heparinized tubes for estimation of arterial blood gas and pH.
Sepsis management: Patients were managed according to guidelines of Surviving
Sepsis Campaign; briefly:
HP management regimen follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Sham Comparator | Management of sepsis/ septic shock via fluids, antibiotics, vasopressors and inotropes. |
|
| Study group | Active Comparator | Management of sepsis/ septic shock in addition to management of hypophosphatemia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glycophos (Sodium Glycerophosphate) | Drug | Management of hypophosphatemia via Glycophos Management of severe sepsis/septic shock via fluid therapy, antibiotics, vasopressors and inotropics. |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality (No.) | Assessment of mortality Assessment of mortality | 15 September 2020 - 15 December 2020 (3 months) |
| Mortality (%) | Assessment of mortality | 15 September 2020 - 15 December 2020 (3 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Noha Hussien, Dr. | Contact | +201222830981 | nohasayedhussien@gmail.com | |
| Sherif Anis, Dr. | Contact | +2001222421674 | sherifganis@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ahmed Kamal, Dr. | Ain Shams University | Principal Investigator |
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| ID | Term |
|---|---|
| D017674 | Hypophosphatemia |
| ID | Term |
|---|---|
| D010760 | Phosphorus Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C029620 | alpha-glycerophosphoric acid |
| D012965 | Sodium Chloride |
| D000900 | Anti-Bacterial Agents |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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|
| Antibiotics | Drug | Management of severe sepsis/septic shock via fluid therapy, antibiotics, vasopressors and inotropics. |
|
|
| Inotropes | Drug | Management of severe sepsis/septic shock via fluid therapy, antibiotics, vasopressors and inotropics. |
|
|
| D017670 |
| Sodium Compounds |
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |