Acute Gastrointestinal Injury in Pediatrics (AGI)

March 29, 2022 updated by: Dr. dr. Antonius Hocky Pudjiadi, SpA(K), Indonesia University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
        • Recruiting
        • Cipto Mangunkusumo hospital
        • Contact:
          • Antonius Pudjiadi, MD, PhD
          • Phone Number: +621500135
          • Email: info@rscm.co.id
        • Sub-Investigator:
          • Fatima Safira Alatas, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All critically ill patients admitted to PICU

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PELOD-2 score
Time Frame: 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.
time of AGI diagnosis, day-1 PELOD-2 score
mortality
Time Frame: days from PICU admission date up to 28 days follow-up
PICU mortality
days from PICU admission date up to 28 days follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Investigators

  • Principal Investigator: Antonius H Pudjiadi, MD, PhD, Indonesia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

September 18, 2020

First Submitted That Met QC Criteria

March 29, 2022

First Posted (Actual)

April 7, 2022

Study Record Updates

Last Update Posted (Actual)

April 7, 2022

Last Update Submitted That Met QC Criteria

March 29, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-04-0471

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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