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NCT Number: NCT06556511

Efficacy Of Zinc Towards The Outcome on Children With 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.

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hasanuddin University

Makassar, South Sulawesi, 90245, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

zinc sulfate

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.

Other names: zinc group

Placebo

Drug

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

Other names: placebo group

Primary outcomes

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

    Time frame: 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

Secondary outcomes

  1. Comparing the mean changes in clinical and laboratory parameters

    Time frame: 10 days

    • 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

Sponsors and collaborators

Lead sponsor

dr. Aldora Jesslyn Oentari

Other

Collaborators

  • Hasanuddin University

Registry information

Official study title

Khasiat Pemberian Zinc Terhadap Outcome Pada Anak Dengan Sepsis

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 16, 2024
Registry last updated
Aug 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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