The Efficacy and Safety of Diluted Oral Phosphate Enema Versus Intravenous Sodium Glycerophosphate in The Treatment of Hypophosphatemia in ICU Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- efficacy in replacing phosphate
研究概览
简要总结
The goal of this clinical trial is to study the efficacy and safety of diluted phosphate enema in treating hypophosphatemia in adults in critical care unit in comparison to intravenous sodium glycero-phosphate as the current standard of care.
The main question it aims to answer is:
can the investigators rely on phosphate enemas as an effective and safe treatment option for hypophosphatemia in critically ill adults, in the era of global shortage of parenteral nutrition solutions and the absence of defined guidelines for treatment of acute hypophosphatemia in those population.
详细描述
A Randomized Controlled Trial - Non inferiority trial of 2 groups, Eligible participants will be randomly assigned to one of two groups (Intervention Group will receive Diluted Oral phosphate enema as the repletion strategy, while Control Group will receive The Standard of care: intravenous sodium glycerophosphate) for the purpose of treatment of hypophosphatemia in critically ill patients.
Dose Calculation: as per hospital protocol and scientific reference(Crook, 2009) 0.32 mmol per kg for mild hypophosphatemia 0.64 mmol per kg for moderate hypophosphatemia
All participants will be reassessed the next day after the intervention and followed up for the occurrence of any side effects, then participants will be followed up again the day after. (Assessment of serum phosphate and sodium along with occurrence of diarrhea or any other side effects).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Critically ill Patients with mild (2-2.4 mg/dl) to moderate (1.5-1.9 mg/dl) hypophosphatemia.
- •Serum phosphorus level less than 2.5mg/dl - between 1.5 - 2.5mg/dl
- •Patients 18 years or older
排除标准
- •Severe hypophosphatemia
- •Serum Phosphorus level less than 1.5 mg/dL
- •Patients on Non-peroral status
- •Ileus (as paralytic ileus, post-operative)
- •Any problem in gut integrity as (intestinal obstruction, Severe Malabsorption, severe diarrhea)
- •Any form of ischemic gut (as mesenteric ischemia, mesenteric gastric occlusion, arterial venous insufficiency)
- •Hemodynamically unstable patients
- •Severe Hypocalcemia or Hypercalcemia at the beginning of the study (when iv phosphate is deemed inappropriate at the discretion of attending physician)
研究组 & 干预措施
Group A - oral diluted phosphate enema
oral diluted phosphate enema
干预措施: Enema Phosphates Sodium (Drug)
Group B - intravenous sodium glycerophosphate
intravenous sodium glycerophosphate
干预措施: Glycophos Injectable Product (Drug)
结局指标
主要结局
efficacy in replacing phosphate
时间窗: 2 days
percentage of patients achieving a normal (\>/=2.5mg/dl) or increase in serum level of phosphate
次要结局
- occurrence of potential side effects(2 days)