Evaluation of the Role of N Acetyl Cysteine and Vitamin D in Improving Outcomes After Corrosive Ingestion
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Stricture formation
研究概览
简要总结
The goal of this clinical trial is to learn if N acetyl cysteine and vitaminD work to improve outcomes after corrosive ingestion in children.
The main questions it aims to answer are:
Does N acetyl cysteine and vitamin D decrease incidence of strictures after corrosive ingestion in children.
Researchers will compare the effect of N acetyl cysteine and vitamin D in decreasing complication , length of hospital stay and start of complete oral intake Eighty patients were randomly assigned into four groups (1 control and 3 intervention groups 20 patients each)
Group 1 (Control group):
o Patients allocated in this group received the standard treatment protocol only according to PCC-ASUH guidelines
Group 2 (NAC group):
o Patients in this group received the standard treatment protocol according to PCC-ASUH guidelines in addition to NAC with loading dose of 150 mg/kg diluted in 200 ml dextrose 5% or saline over 1 hour, followed by a maintenance dose of 50 mg/kg diluted in 500 ml of dextrose 5% or saline over 4 hours then followed by 100 ml/kg diluted in 1000 ml of dextrose 5% or saline over 16 hours
Group 3 (Vitamin D group):
Patients in this group received the standard treatment protocol according to PCC-ASUH guidelines in addition to vitamin D in a single intramuscular high-dose (300,000 IU) which was given to all patients regardless patient's age
Group 4 (NAC+Vitamin D group):
Patients in this group received the standard treatment protocol according to PCC-ASUH guidelines in addition to both vitamin D and NAC, in the same doses as groups (2 and 3
详细描述
The current study is a controlled randomized, single-blinded clinical trial, conducted on acutely poisoned patients with confirmed history of corrosive ingestion who were admitted to the Poison Control Center, Ain Shams University Hospitals (PCC-ASUH) The required sample size is 80 patients, 20 patients in each group according to the recommendation of statistics committee (Community Medicine, Environmental, and Occupational Medicine Department - Faculty of Medicine, Ain shams University)
Eighty patients were randomly assigned into four groups (1 control and 3 intervention groups 20 patients each)
Group 1 (Control group):
o Patients allocated in this group received the standard treatment protocol only according to PCC-ASUH guideline This included patient stabilization, maintaining patent airways, oxygen administration and ventilatory support when necessary.
In patients presenting with oral symptoms such as lip edema, excessive drooling (sialorrhea), or oral ulcers, the child was kept NPO to prevent further irritation. Topical treatments including antibiotics, anti-inflammatory agents, and antifungals were applied to manage local infection and inflammation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The study included all patients aged from 0 to 18 years old, of both sex, admitted to the PCC-ASUH with confirmed history of corrosive ingestion and exhibiting moderate or severe symptoms (as determined by Poisoning Severity Score 2 or 3, respectively) and DROOL score (Drooling, Reluctance, Oropharynx, Others, and leukocytosis) ≤ 6
排除标准
- •o Asymptomatic patients.
- •Patients exposed to corrosives through routes other than ingestion (e.g., inhalation, dermal or eye contact).
- •Patients with a delay time of more than 24 h.
- •Patients who co-ingested other poisons.
- •Patients presented with GIT perforation after corrosive ingestion.
- •Patients who received treatment before admission.
- •Patients receiving chemotherapy or radiation.
- •Patients with known blood disorders or malignancy.
- •Patients with history of blood transfusion in the last 90 days.
- •Patients with recent infections in the last 14 day
研究组 & 干预措施
vitamin D group
Patients in this group received the standard treatment protocol according to PCC-ASUH guidelines in addition to vitamin D in a single intramuscular high-dose (300,000 IU) which was given to all patients regardless patient's age
干预措施: Vitamin D (Cholecalciferol ) (Drug)
control
Patients allocated in this group will receive the standard treatment protocol only according to PCC-ASUH guidelines
干预措施: control group (Drug)
N acetyl cysteine group
- Patients in this group received the standard treatment protocol according to PCC-ASUH guidelines in addition to NAC with loading dose of 150 mg/kg diluted in 200 ml dextrose 5% or saline over 1 hour, followed by a maintenance dose of 50 mg/kg diluted in 500 ml of dextrose 5% or saline over 4 hours then followed by 100 ml/kg diluted in 1000 ml of dextrose 5% or saline over 16 hours
- Preparation and administration of NAC were adjusted according to the age of the patient. In those >12 years old, total volume (NAC and IV fluid) for the bolus, 4-hour infusion, and 16 hours infusion was 200 ml, 500 ml, and 1 liter, respectively. In children <12 years but over 20 kg, volumes were 100 ml, 250 ml, and 500 ml respectively. In those under 20 kg volumes were 3 ml/kg, 7 ml/kg, and 14 ml/kg respectively
干预措施: N Acetyl Cysteine (Drug)
N acetyl cysteine group
- Patients in this group received the standard treatment protocol according to PCC-ASUH guidelines in addition to NAC with loading dose of 150 mg/kg diluted in 200 ml dextrose 5% or saline over 1 hour, followed by a maintenance dose of 50 mg/kg diluted in 500 ml of dextrose 5% or saline over 4 hours then followed by 100 ml/kg diluted in 1000 ml of dextrose 5% or saline over 16 hours
- Preparation and administration of NAC were adjusted according to the age of the patient. In those >12 years old, total volume (NAC and IV fluid) for the bolus, 4-hour infusion, and 16 hours infusion was 200 ml, 500 ml, and 1 liter, respectively. In children <12 years but over 20 kg, volumes were 100 ml, 250 ml, and 500 ml respectively. In those under 20 kg volumes were 3 ml/kg, 7 ml/kg, and 14 ml/kg respectively
干预措施: control group (Drug)
vitamin D group
Patients in this group received the standard treatment protocol according to PCC-ASUH guidelines in addition to vitamin D in a single intramuscular high-dose (300,000 IU) which was given to all patients regardless patient's age
干预措施: control group (Drug)
N acetyl cysteine and Vitamin D group
Patients in this group received the standard treatment protocol according to PCC-ASUH guidelines in addition to both vitamin D and NAC, in the same doses as groups (2 and 3).
干预措施: N Acetyl Cysteine (Drug)
N acetyl cysteine and Vitamin D group
Patients in this group received the standard treatment protocol according to PCC-ASUH guidelines in addition to both vitamin D and NAC, in the same doses as groups (2 and 3).
干预措施: Vitamin D (Cholecalciferol ) (Drug)
N acetyl cysteine and Vitamin D group
Patients in this group received the standard treatment protocol according to PCC-ASUH guidelines in addition to both vitamin D and NAC, in the same doses as groups (2 and 3).
干预措施: control group (Drug)
结局指标
主要结局
Stricture formation
时间窗: 21 days after corrosive ingestion
Stenosis of esophygeal lumen or gastric lumen after corrosive ingestion which will be seen in barium swallow and meal
次要结局
未报告次要终点