Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06556511
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-23
Brief Title:
Efficacy Of Zinc Towards The Outcome on Children With Sepsis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Khasiat Pemberian Zinc Terhadap Outcome Pada Anak Dengan Sepsis
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 parentscaregivers 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 parentscaregivers 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 PF 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 210 software is used for data analysis A p value 005 was considered for statistical analysis This study was approved by the ethics and research committee of the faculty of medicine at Hasanuddin University
The inclusion criteria were children aged 1 month to 18 years diagnosed with sepsis and parentscaregivers 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 parentscaregivers 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 PF 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 210 software is used for data analysis A p value 005 was considered for statistical analysis This study was approved by the ethics and research committee of the faculty of medicine at Hasanuddin University
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None