Acute Gastrointestinal InjuryAGINCT05315245
Acute Gastrointestinal Injury in Pediatrics
An observational study of Acute Gastrointestinal Injury and Gastrointestinal Failure, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
Critically Ill children may develop acute gastrointestinal injury secondary to severe inflammation. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Acute Gastrointestinal Injury, Gastrointestinal Failure, Critical Illness
- What is being tested?
- AGI
- How many people
- 90 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 May 2019to 1 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All critically ill patients admitted to PICU
Who may be able to join
- critically ill pediatric patients receiving care at the PICU
- presence of AGI (any degree)
Who cannot join
- patients who's body weight cannot be measured
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Cipto Mangunkusumo Hospital
Jakarta Pusat, DKI Jakarta, 10430
Antonius Pudjiadi, MD, PhD, +621500135, info@rscm.co.id
Fatima Safira Alatas, MD, PhD
About this study
Official title: 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.
Read the 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
- Being tested
- AGI
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGIOther
no intervention, only observation
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: time of AGI diagnosis, day-1 PELOD-2 score
mortality
PICU mortality
Measured: days from PICU admission date up to 28 days follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start1 May 2019
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Gastrointestinal InjuryStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. dr. Antonius Hocky Pudjiadi, SpA(K), Universitas Indonesia
- Investigators
- Antonius H Pudjiadi, MD, PhD, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05315245
- Sponsor's protocol ID
- 19-04-0471
- Acronym
- AGI
- Status last verified
- Mar 2022
- First submitted
- 18 Sep 2020
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Gastrointestinal Injury in Critically Ill Children in Pediatric Intensive Care Unit of Cipto Mangunkusumo Hospital
- ClinicalTrials.gov ID
- NCT05315245
- Acronym / sponsor ID
- AGI / 19-04-0471
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 7 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All critically ill patients admitted to PICU
Key inclusion criteria (2 listed)
- critically ill pediatric patients receiving care at the PICU
- presence of AGI (any degree)
Key exclusion criteria (1 listed)
- patients who's body weight cannot be measured
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AGIno intervention, only observation | Other | – |
Primary outcome
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.
mortality
Time frame: days from PICU admission date up to 28 days follow-up
PICU mortality
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonius H Pudjiadi, MD, PhD principal investigator
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Gastrointestinal Injury and Gastrointestinal Failure, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonius H Pudjiadi, MD, PhD (+628164812035, ahpudjiadi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PELOD-2 score (time frame: time of AGI diagnosis, day-1 PELOD-2 score). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022.