Hupophosphatemia Levels Deleteriously Affect Outcome of Patients With Severe Sepsis/Septic Shock Admitted to ICU
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 主要终点
- Mortality (No.)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with severe sepsis and/or septic shock within 24 hours of admission to ICU
排除标准
- •children and adulthoods younger than 18 years
- •pregnancy
- •severe hemorrhagic shock
- •maintenance on immunosuppressant therapy for any indication
- •patients who are expected to die within the first 24 hours after admission
研究组 & 干预措施
Control group
Management of sepsis/ septic shock via fluids, antibiotics, vasopressors and inotropes.
干预措施: Antibiotics (Drug)
Control group
Management of sepsis/ septic shock via fluids, antibiotics, vasopressors and inotropes.
干预措施: Inotropes (Drug)
Study group
Management of sepsis/ septic shock in addition to management of hypophosphatemia.
干预措施: Glycophos (Sodium Glycerophosphate) (Drug)
Study group
Management of sepsis/ septic shock in addition to management of hypophosphatemia.
干预措施: Antibiotics (Drug)
Study group
Management of sepsis/ septic shock in addition to management of hypophosphatemia.
干预措施: Inotropes (Drug)
结局指标
主要结局
Mortality (No.)
时间窗: 15 September 2020 - 15 December 2020 (3 months)
Assessment of mortality Assessment of mortality
Mortality (%)
时间窗: 15 September 2020 - 15 December 2020 (3 months)
Assessment of mortality
次要结局
未报告次要终点
研究者
Noha Sayed Hussien
Clinical Professor
Ain Shams University
