Hypophosphatemia Clinical Trial
Official title:
Hupophosphatemia Levels Deleteriously Affect Outcome of Patients With Severe Sepsis/Septic Shock Admitted to ICU
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:
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)
= 0.5 x body weight x (1.25 - [serum Pi]).
2. Preparation that will be used: Glycophos®, Fresenius Kabi Egypt (organic phosphate
solution 1mmol/ml). 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.
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