Clinical trial NCT06556511: Efficacy Of Zinc Towards The Outcome on Children With Sepsis
Official title: Khasiat Pemberian Zinc Terhadap Outcome Pada Anak Dengan Sepsis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Keywords: Sepsis
Zinc
Lead sponsor: Hasanuddin University
Sponsor class: OTHER
Collaborators: name: Hasanuddin University
First posted: 2024-08-16
Enrollment: 140
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Children with diagnosis of sepsis age 1 month to 18 years. Patients were divided into two groups, namely zinc group which received standard therapy with zinc, and placebo group which received standard therapy with placebo
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Diarrhea
* 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
* Death

Primary outcomes:
measure: This study was to compare the effectiveness of standard therapy with zinc in children with sepsis
timeFrame: 10 days
Secondary outcomes:
measure: Comparing the mean changes in clinical and laboratory parameters
timeFrame: 10 days
Other outcomes:
Locations:
city: Makassar
country: Indonesia
facility: Hasanuddin University
state: South Sulawesi
Study officials:
affiliation: Hasanuddin University
name: Aldora Jesslyn Oentari
role: PRINCIPAL_INVESTIGATOR
References: