Ignite Creation Date:
2024-05-06 @ 3:04 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04519762
Status:
UNKNOWN
Last Update Posted:
2020-08-20
First Post:
2020-08-12
Brief Title:
Levels of Hypophosphatemia Affect Outcome of Septic Patients in ICU
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
Hupophosphatemia Levels Deleteriously Affect Outcome of Patients With Severe SepsisSeptic Shock Admitted to ICU
Status:
UNKNOWN
Status Verified Date:
2020-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The current study aimed to determine the incidence of hypophosphatemia HP among severe sepsisseptic 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 outcomesThus 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
Detailed Description:
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 25 mgdl and Study group will include patients having serum Pi25 mgdl and will be further sub-grouped according to severity of HP into mild HP 2-25 mgdl moderate 1-19 mgdl or severe 1 mgdl
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
1 Fluid therapy
2 Vasoactive drug therapy
3 Intropics
4 Antibiotic therapy
HP management regimen follows
1 Calculation of supplementation dose according to the equation phosphate dose in mmol 05 x body weight x 125 - serum Pi
2 Preparation that will be used Glycophos Fresenius Kabi Egypt organic phosphate solution 1mmolml Vial 20 ml 1ml contains 1mmol of phosphate and 2mmol of sodium
3 Dilution will be diluted prior to parenteral administration 20 ml of sodium-glycerophosphate diluted in 30 cc of dextrose 5 administered by syringe pump 50 mL
4 The total calculated dose will be divided into three doses every 8 hours
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 25 mgdl and Study group will include patients having serum Pi25 mgdl and will be further sub-grouped according to severity of HP into mild HP 2-25 mgdl moderate 1-19 mgdl or severe 1 mgdl
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
1 Fluid therapy
2 Vasoactive drug therapy
3 Intropics
4 Antibiotic therapy
HP management regimen follows
1 Calculation of supplementation dose according to the equation phosphate dose in mmol 05 x body weight x 125 - serum Pi
2 Preparation that will be used Glycophos Fresenius Kabi Egypt organic phosphate solution 1mmolml Vial 20 ml 1ml contains 1mmol of phosphate and 2mmol of sodium
3 Dilution will be diluted prior to parenteral administration 20 ml of sodium-glycerophosphate diluted in 30 cc of dextrose 5 administered by syringe pump 50 mL
4 The total calculated dose will be divided into three doses every 8 hours
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None