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临床试验/NCT06226402
NCT06226402招募中不适用

Comparative Study Between the Effect of Nebulized and Intravenous Hypertonic Saline 3% on the Management of Patients With Acute Respiratory Distress Syndrome

Tanta University1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2023年9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
状态
招募中
入组人数
105
试验地点
1
主要终点
Number of patients who will need mechanical ventilation

研究概览

简要总结

The aim of our study is to compare between the effect of nebulized and intravenous injection of hypertonic saline 3% on the outcome of patients with acute respiratory distress syndrome.

详细描述

Acute Respiratory Distress Syndrome (ARDS) is a life threatening form of respiratory failure, characterized by acute, diffuse, inflammatory lung injury that results in increased alveolar capillary permeability and the development of non-hydrostatic pulmonary edema.

Clinically, ARDS manifests as marked hypoxemia and respiratory distress; patients often progress to respiratory failure that requires invasive mechanical ventilation in the intensive care unit.

No specific pharmacological treatment is available for ARDS, which is associated with high morbidity and mortality. The mainstay of therapy in ARDS is supportive therapy and invasive mechanical ventilation based on lung-protective strategies using low tidal volume (VT) at 4-6 ml/kg of predicted body weight (PBW) and plateau pressure (p PLAT) below 30 cm H2O, but other adjunctive therapies have been trialed with various degrees of efficacy, including neuromuscular blockade, prone positioning, recruitment maneuvers (RMs), vasodilators, and extracorporeal membrane oxygenation (ECMO).

Hypertonic saline 3% NaCl with 513 mEq/L of Na and 513 mEq/L of Cl is a potent anti-inflammatory agent, and immunomodulator, which exerts inhibitory effects in several stages of the inflammatory cascade. Hypertonic saline, at a cellular level, decreases alveolar macrophage activation, polymorph nuclear leucocyte recruitment, priming and activation, as well as cell surface adhesion molecule expression. High plasma sodium contributes to high plasma osmolality which can be lung protective and would seem to be a logical choice for treatment of ARDS.

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
21 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age from 21 to 60 years old.
  • Both sexes.
  • Patients with mild and moderate ARDS whose PaO2/FiO2 ratio ≥ 150 according to the Berlin definition of Acute Respiratory Distress Syndrome.

排除标准

  • Refusal to participate in the study.
  • Malignancy.
  • Patients on chemotherapy.
  • Decompensated renal, hepatic and cardiac disease.
  • Patients with hypernatremia whose serum Na above 155 mEq/L.
  • Patients with ARDS whose PaO2/FiO2 ratio > 150.

研究组 & 干预措施

Inhalational group

Experimental

Patients will receive the standard pharmacotherapy + hypertonic saline 3% (5ml) nebulizer /8hr.

干预措施: Hypertonic saline 3% nebulizer (Drug)

Intravenous group

Experimental

Patients will receive the standard pharmacotherapy + hypertonic saline 3% intravenous over 24 hours to maintain plasma Na level between 145-150 mEq/L.

干预措施: Intravenous hypertonic saline 3% (Drug)

结局指标

主要结局

Number of patients who will need mechanical ventilation

时间窗: 28 days after intervention

Number of patients who will need mechanical ventilation will be assessed.

次要结局

  • Lung injury score (Murray score)(24 hours after intervention)
  • Length of ICU stay(28 days after intervention)
  • Incidence of mortality(28 days after intervention)

研究者

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

Mohamed Elsayed Mohamed Elfakhrany

Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Tanta University

研究点 (1)

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