Efficacy Of Zinc Towards The Outcome on Children With Sepsis

NCT06556511 | Completed

• 1 other identifier: Zinc and Placebo
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis

Keywords

Sepsis; Zinc

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Comparing the mean changes in clinical and laboratory parameters

  10 days

Study Arms (2)

zinc group

EXPERIMENTAL

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

Drug: Zinc Sulfate

placebo group

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

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.

Also known as: zinc group

zinc group

Placebo DRUG

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

Also known as: placebo group

placebo group

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• dr. Aldora Jesslyn Oentari: lead
• Hasanuddin University: collaborator

Study Sites (1)

Hasanuddin University

Makassar, South Sulawesi, 90245, Indonesia

Location

MeSH Terms

Conditions

Sepsis

Interventions

Zinc Sulfate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Inorganic Chemicals; Zinc Compounds

Study Officials

• Aldora Jesslyn Oentari

  Hasanuddin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: resident doctor

Model Details: 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

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: August 16, 2024
• Study Start: February 1, 2024
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: August 16, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)