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临床试验/NCT06556511
NCT06556511已完成不适用

Khasiat Pemberian Zinc Terhadap Outcome Pada Anak Dengan Sepsis

dr. Aldora Jesslyn Oentari1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2024年2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
已完成
发起方
入组人数
140
试验地点
1
主要终点
This study was to compare the effectiveness of standard therapy with zinc in children with sepsis

研究概览

简要总结

Sepsis is a life-threatening organ failure induced by a compromised immune response to infection. Sepsis is a leading cause of morbidity and mortality (50-60%) in children treated in inpatient and critical care units. Children suffering from immunodeficiency have a higher mortality rate. Several studies in recent years have revealed that zinc homeostasis may be a significant role in the prevention of sepsis. It was important to conduct this study to determine the efficacy of zinc in children suffering from sepsis.

详细描述

This research is a randomized controlled trial with parallel study design conducted in Makassar, South of Sulawesi, Indonesia from February to May 2024. This study was conducted on children with a diagnosis of sepsis. Patients were divided into two groups, namely zinc group which received standard therapy with zinc and placebo group which received standard therapy with placebo.

The inclusion criteria were children aged 1 month to 18 years, diagnosed with sepsis, and parents/caregivers willing to participate their children in this study. Patients with diarrhea, malnutrition, Acute Kidney Injury due to kidney illness, hematological diseases, patients who have received zinc in the previous month, and patients who leave on their own request are all excluded from this study. Patients who not taking medication for up to three days in a row, either due to forgetfulness or self-determination, or due to side effects, and being unable to complete the study before the end date for various reasons, including death were declared dropouts.

Researchers will provide informed consent to parents/caregivers of children who met the research criteria. Anamnesis, general physical examination, and clinical also laboratory parameters were examined on day 0, 8, and 11 after zinc and placebo supplementation, such as; degree of consciousness, use of mechanical ventilators, P/F ratio, MAP, lactate levels, serum leukocyte and platelet counts, CRP and procalcitonin levels, lactate levels, sepsis progression, and mortality rates. The research results are recorded in a research form and the data is grouped and SPSS version 21.0 software is used for data analysis. A p value <0.05 was considered for statistical analysis. This study was approved by the ethics and research committee of the faculty of medicine, at Hasanuddin University.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
1 Month 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Children aged 1 month to 18 years with diagnosis of sepsis

排除标准

  • Malnutrition
  • Acute Kidney Injury due to kidney illness
  • Hematological diseases
  • Have received zinc in the previous month
  • Leave on their own request
  • Dropping out criteria:
  • Not taking medication for up to three days in a row

研究组 & 干预措施

zinc group

Experimental

Children with diagnosis of sepsis. Patients who received standard therapy with zinc for 10 days

干预措施: Zinc Sulfate (Drug)

placebo group

Placebo Comparator

Children with diagnosis of sepsis. Patients who received standard therapy with placebo for 10 days

干预措施: Placebo (Drug)

结局指标

主要结局

This study was to compare the effectiveness of standard therapy with zinc in children with sepsis

时间窗: 10 days

Comparing the level of awareness, used of a mechanical ventilator, P/F ratio, Mean Arterial Pressure (MAP), serum leukocytes and platelets, C-Reactive Protein (CRP) and procalcitonin levels, lactate levels, sepsis progression, and patient mortality between zinc group and placebo group on day 0, 8, and 11

次要结局

  • Comparing the mean changes in clinical and laboratory parameters(10 days)

研究者

发起方
dr. Aldora Jesslyn Oentari
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

dr. Aldora Jesslyn Oentari

resident doctor

Hasanuddin University

研究点 (1)

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