Efficacy Of Zinc Towards The Outcome on Children With Sepsis

Khasiat Pemberian Zinc Terhadap Outcome Pada Anak Dengan Sepsis

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.

Study Overview

• Status: Completed
• Conditions: Sepsis
• Intervention / Treatment: Drug: Zinc Sulfate; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • South Sulawesi
    • Makassar, South Sulawesi, Indonesia, 90245
      • Hasanuddin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: zinc group; Children with diagnosis of sepsis. Patients who received standard therapy with zinc for 10 days	Drug: 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.; Other Names: zinc group
Placebo Comparator: placebo group; Children with diagnosis of sepsis. Patients who received standard therapy with placebo for 10 days	Drug: Placebo; Placebo is administered with standard therapy in the placebo group for a period of 10 days.; Other Names: placebo group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
This study was to compare the effectiveness of standard therapy with zinc in children with sepsis	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	10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparing the mean changes in clinical and laboratory parameters	Comparing the difference of 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 after treatment between zinc group and placebo group; Comparing the difference of 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 before and after treatment in the zinc group; Comparing the difference of 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 before and after treatment in the zinc group	10 days

Collaborators and Investigators

• Sponsor: dr. Aldora Jesslyn Oentari
• Collaborators: Hasanuddin University
• Investigators: Principal Investigator: Aldora Jesslyn Oentari, Hasanuddin University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Actual): May 31, 2024
• Study Completion (Actual): May 31, 2024

Study Registration Dates

• First Submitted: July 23, 2024
• First Submitted That Met QC Criteria: August 13, 2024
• First Posted (Actual): August 16, 2024

Study Record Updates

• Last Update Posted (Actual): August 16, 2024
• Last Update Submitted That Met QC Criteria: August 13, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Sepsis; Zinc
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia; Physiological Effects of Drugs; Dermatologic Agents; Trace Elements; Micronutrients; Astringents; Zinc; Zinc Sulfate
• Other Study ID Numbers: Zinc and Placebo

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No