Acute Gastrointestinal Injury in Pediatrics

• Conditions: Critical Illness; Acute Gastrointestinal Injury; Gastrointestinal Failure

• Registration Number: NCT05315245
• Lead Sponsor: Indonesia University

Brief Summary

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

Detailed 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

Study Timeline

• Study Start: 2019-05-01
• Study First Submitted: 2020-09-18
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-29
• Last Update Submitted: 2022-03-29
• Study First Posted: 2022-04-07
• Last Update Posted: 2022-04-07
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PELOD-2 score	time of AGI diagnosis, day-1 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.
mortality	days from PICU admission date up to 28 days follow-up	PICU mortality

Trial Locations

Locations (1)

Cipto Mangunkusumo Hospital; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia