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临床试验/NCT04519762
NCT04519762Unknown4 期

Hupophosphatemia Levels Deleteriously Affect Outcome of Patients With Severe Sepsis/Septic Shock Admitted to ICU

Ain Shams University0 个研究点目标入组 100 人开始时间: 2020年9月15日最近更新:
适应症
干预措施
相关药物

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

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

Sham Comparator

Management of sepsis/ septic shock via fluids, antibiotics, vasopressors and inotropes.

干预措施: Antibiotics (Drug)

Control group

Sham Comparator

Management of sepsis/ septic shock via fluids, antibiotics, vasopressors and inotropes.

干预措施: Inotropes (Drug)

Study group

Active Comparator

Management of sepsis/ septic shock in addition to management of hypophosphatemia.

干预措施: Glycophos (Sodium Glycerophosphate) (Drug)

Study group

Active Comparator

Management of sepsis/ septic shock in addition to management of hypophosphatemia.

干预措施: Antibiotics (Drug)

Study group

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Noha Sayed Hussien

Clinical Professor

Ain Shams University

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