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临床试验/NCT03741257
NCT03741257Unknown不适用

Hypertonic Saline 3% Compared to Hypertonic Saline 1.8% for Fluid Management of Intestinal Obstruction Surgery

Cairo University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年11月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
Total volume of infused fluids

研究概览

简要总结

Background and Rationale :

Perioperative fluid management is a challenging issue in surgical care especially in a procedure specific model. Recently hypertonic saline (HS) has the advantage of using the patient's own total body water by drawing interstitial space. Although it still controversial whether HS is associated with benefits in specific patient populations, particularly with respect to site of lesion and illness severity; these data provide insight into therapeutic modalities to curtail ileus formation.

Objectives :

  • Measurement of total volume of fluid infused, the need of inotropic or vasopressor to maintain adequate hemodynamic parameters with assessment of electrolyte disturbances and S.lactate
  • The incidence rate of surgical complications; infection and anastomotic dehiscence

Study population & Sample size :

There were no previous trials comparing the two studied groups of the current trial. We expected a small standardized effect size of 0.2. Based on this effect size, 25 subjects will be needed to elicit the difference between the two groups at an alpha level of 0.05 and power of 0.9 (Whitehead et al; 2016).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 20-70 years old
  • BMI 25-40kg/m.

排除标准

  • Severe CVS diseases (EF<50%)
  • Severe pulmonary diseases (Pulmonary function test ≤ 50% of predicted)
  • Neurological disorders; Psychological diseases, demyelinating lesions, Parkinsonism, motor or sensory disorders.
  • Pregnancy.
  • Severe chronic renal disease (s. Creatinine> 2gm/dl or patients on dialysis).
  • Severe hepatic impairment (Child & Pugh classification class C).
  • Acid-base and electrolytes disturbances.

研究组 & 干预措施

Group A

Active Comparator

Received Hypertonic saline 3% as resuscitation fluid.

干预措施: Hypertonic saline (Drug)

Group B

Active Comparator

Received Hypertonic saline 1.8% as resuscitation

干预措施: Hypertonic saline (Drug)

结局指标

主要结局

Total volume of infused fluids

时间窗: 24 hours

the total volume of fluids given to subjects intraoperatively and postoperatively

次要结局

  • surgical complications rate(4 days)

研究者

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

Ahmed Mohamed Lotfy

lecturer of anesthesia and intensive care

Cairo University

研究点 (1)

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