NCT05315245

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2020

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

April 7, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

April 7, 2022

Status Verified

March 1, 2022

Enrollment Period

3.6 years

First QC Date

September 18, 2020

Last Update Submit

March 29, 2022

Conditions

Acute Gastrointestinal InjuryGastrointestinal FailureCritical Illness

Outcome Measures

Primary Outcomes (2)

  • 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

    PICU mortality

    days from PICU admission date up to 28 days follow-up

Interventions

AGIOTHER

no intervention, only observation

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All critically ill patients admitted to PICU

You may qualify if:

  • critically ill pediatric patients receiving care at the PICU
  • presence of AGI (any degree)

You may not qualify if:

  • patients who's body weight cannot be measured

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

RECRUITING

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Antonius H Pudjiadi, MD, PhD

    Indonesia University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonius H Pudjiadi, MD, PhD

CONTACT

+628164812035ahpudjiadi@gmail.com

Gryselda Hanafi, MD

CONTACT

087170113134gryseldahanafi@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 18, 2020

First Posted

April 7, 2022

Study Start

May 1, 2019

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

April 7, 2022

Record last verified: 2022-03

Locations

ID(1)