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NCT05315245 Clinical Trial

Acute Gastrointestinal Injury in Pediatrics

Critical Illness Clinical Trial

— AGI  

Official title:
Acute Gastrointestinal Injury in Critically Ill Children in Pediatric Intensive Care Unit of Cipto Mangunkusumo Hospital

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05315245
Other study ID # 19-04-0471
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 1, 2019
Est. completion date December 1, 2022

Study information
Verified date March 2022
Source Indonesia University
Contact Antonius H Pudjiadi, MD, PhD
Phone +628164812035
Email ahpudjiadi@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Critically Ill children may develop acute gastrointestinal injury secondary to severe inflammation.

Description:

Data collection from enrolled subjects including profile, laboratory examinations, inflammatory markers on day 1 and day 3, nutritional support and daily calorie intake, and finally outcome of the patient

Recruitment information / eligibility
Status Recruiting
Enrollment 90
Est. completion date December 1, 2022
Est. primary completion date December 1, 2022
Accepts healthy volunteers No
Gender All
Age group 1 Month to 18 Years
Eligibility Inclusion Criteria: - critically ill pediatric patients receiving care at the PICU - presence of AGI (any degree) Exclusion Criteria: - patients who's body weight cannot be measured

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• AGI
no intervention, only observation

Locations
Country Name City State
Indonesia Cipto Mangunkusumo Hospital Jakarta Pusat DKI Jakarta

Sponsors (1)
Lead Sponsor Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome
Type Measure Description Time frame Safety issue
Primary PELOD-2 score The Pediatric Logistic Organ Dysfunction (PELOD)-2 score is used to predict mortality and assess organ dysfunction. It consist of 10 components, assessing 5 organ dysfunction. The minimum score of PELOD-2 is 0 and the maximum score is 33. With the increasing organ dysfunction, the probability of death also increases. time of AGI diagnosis, day-1 PELOD-2 score
Primary mortality PICU mortality days from PICU admission date up to 28 days follow-up
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