Efficacy Of Zinc Towards The Outcome on Children With Sepsis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2024-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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zinc group

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

Group Type EXPERIMENTAL

Zinc Sulfate

Intervention Type DRUG

Zinc is administered at a dose of 10 mg per day for children under the age of 6 months, and 20 mg per day for children above the age of 6 months accompanied with standard therapy in the zinc group for a period of 10 days.

placebo group

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo is administered with standard therapy in the placebo group for a period of 10 days.

Interventions

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Zinc Sulfate

Zinc is administered at a dose of 10 mg per day for children under the age of 6 months, and 20 mg per day for children above the age of 6 months accompanied with standard therapy in the zinc group for a period of 10 days.

Intervention Type DRUG

Placebo

Placebo is administered with standard therapy in the placebo group for a period of 10 days.

Intervention Type DRUG

Other Intervention Names

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zinc group placebo group

Eligibility Criteria

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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

Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No