Gastrointestinal DysfunctionNCT05867043
Postoperative Gastrointestinal Dysfunction After High Risk Surgery
An observational study of Gastrointestinal Dysfunction and Surgery, run by Aldy Heriwardito at 1 site in Indonesia.
Trial summary
This study aims to find out the role of plasma I-FABP level, SOFA score, fluid balance, and vasopressor dose in predicting gastrointestinal dysfunction in high-risk postoperative patients treated in ICU Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Dysfunction, Surgery, Postoperative Complications
- How many people
- 66 participants
- Where
- 1 siteIndonesia
- Study dates
- 23 Jan 2023to 31 Dec 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: High-risk postoperative patients treated in Intensive Care Unit of Emergency Department or Surgery Unit in Cipto Mangunkusumo General Hospital who meet eligibility criteria
Who may be able to join
- High-risk postoperative patients
- Patients treated in Intensive Care Unit of Emergency Department or Surgery Unit in Cipto Mangunkusumo General Hospital
- Age >18 years old
- Patients or family give written consent to follow the study
Who cannot join
- Patients with late trimester-pregnancy when admitted to ICU
- Patients undergo cardiac surgery
- Patients with gastrointestinal disorders requiring routine therapy
- Patients undergo surgery involving bowels
- Patients undergo surgical treatment for burn
- Patients treated in ICU >24 hours before surgery
Show all 11Show fewer
- Drop-out Criteria
- Unable to obtain blood sampling for I-FABP level examination in ICU
- Unable to perform Acute Gastrointestinal Injury examination in ICU
- Patients died within <24 hours treatment in ICU
- Patients or family decide to quit from the study
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Cipto Mangunkusumo Central National Hospital
Jakarta Pusat, Jakarta Special Capital Region, 10430
About this study
Official title: Postoperative Gastrointestinal Dysfunction After High Risk Surgery: A Prospective Study in Adult Intensive Care Unit
This study aims to find out the role of plasma I-FABP level, SOFA score, fluid balance, and vasopressor dose in predicting gastrointestinal dysfunction in high-risk postoperative patients treated in ICU
Read the detailed description
This is a prospective cohort study to find out the role of plasma I-FABP level, SOFA score, fluid balance, and vasopressor dose in predicting gastrointestinal dysfunction in high-risk postoperative patients treated in ICU. The characteristics of patients who meet the eligibility criteria were obtained. Blood sampling during admission is done for I-FABP level measurement and will be repeated after 24 hours. Blood sample which is not directly processed will be stored in refrigerator under 6-8C temperature. Evaluation of Acute Gastrointestinal Injury signs and symptoms is done. The re-evaluation is performed every day. If patients experiencing AGI signs and symptoms, monitoring and treatment based on condition are done. Routine follow-up is continued during hospitalisation in ICU. After all sample are collected, I-FABP level is assessed quantitatively using ELISA.
- Keywords
- gastrointestinal dysfunction, high risk surgery, postoperative
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Experience gastrointestinal dysfunction | Gastrointestinal dysfunction is defined as acute gastrointestinal injury (AGI) score >= 2 based on ESICM criteria, monitored within 72 hours according to early postoperative gastrointestinal dysfunction. Experience gastrointestinal dysfunction = AGI score >=2 | |
| Did not experience gastrointestinal dysfunction | Did not experience gastrointestinal dysfunction = AGI score <2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
I-FABP plasma level
I-FABP plasma level is measured during admission and 24 hours after. I-FABP plasma level during admission is used as the data, while the 24 hours after admission is used to evaluate any bowel injury during treatment in ICU.
Measured: During admission
I-FABP plasma level
I-FABP plasma level is measured during admission and 24 hours after. I-FABP plasma level during admission is used as the data, while the 24 hours after admission is used to evaluate any bowel injury during treatment in ICU.
Measured: 24 hours after admission
Vasopressor dose
Mean dose of norepinephrine (mcg/kg/min) used during intraoperative period. It is measured proportionally to the duration of use based on anesthesia record.
Measured: During surgery (intraoperative period)
SOFA score
Score used to evaluate patients' status during treatment in ICU and to determine the severity of organ dysfunction. It is measured during patients' admission to ICU
Measured: During admission in ICU (postoperative period)
Fluid balance
The net between fluid output and input during intraoperative period.
Measured: During surgery (intraoperative period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start23 Jan 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DysfunctionStudies of the same condition, open and under way.
- 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
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aldy Heriwardito
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aldy Heriwardito, Universitas Indonesia
- Investigators
- Aldy Heriwardito, MD, Principal investigator, Fakultas Kedokteran Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05867043
- Sponsor's protocol ID
- IndonesiaUAnes939
- Status last verified
- May 2023
- First submitted
- 18 Apr 2023
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Gastrointestinal Dysfunction After High Risk Surgery: A Prospective Study in Adult Intensive Care Unit
- ClinicalTrials.gov ID
- NCT05867043
- Acronym / sponsor ID
- IndonesiaUAnes939
- Keywords
- gastrointestinal dysfunction, high risk surgery, postoperative
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Aldy HeriwarditoUniversity, hospital or other
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 19 May 2023 (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.
This study aims to find out the role of plasma I-FABP level, SOFA score, fluid balance, and vasopressor dose in predicting gastrointestinal dysfunction in high-risk postoperative patients treated in ICU
Detailed description
This is a prospective cohort study to find out the role of plasma I-FABP level, SOFA score, fluid balance, and vasopressor dose in predicting gastrointestinal dysfunction in high-risk postoperative patients treated in ICU. The characteristics of patients who meet the eligibility criteria were obtained. Blood sampling during admission is done for I-FABP level measurement and will be repeated after 24 hours. Blood sample which is not directly processed will be stored in refrigerator under 6-8C temperature. Evaluation of Acute Gastrointestinal Injury signs and symptoms is done. The re-evaluation is performed every day. If patients experiencing AGI signs and symptoms, monitoring and treatment based on condition are done. Routine follow-up is continued during hospitalisation in ICU. After all sample are collected, I-FABP level is assessed quantitatively using ELISA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experience gastrointestinal dysfunction | – | –Gastrointestinal dysfunction is defined as acute gastrointestinal injury (AGI) score >= 2 based on ESICM criteria, monitored within 72 hours according to early postoperative gastrointestinal dysfunction. Experience gastrointestinal dysfunction = AGI score >=2 |
| Did not experience gastrointestinal dysfunction | – | –Did not experience gastrointestinal dysfunction = AGI score <2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- High-risk postoperative patients treated in Intensive Care Unit of Emergency Department or Surgery Unit in Cipto Mangunkusumo General Hospital who meet eligibility criteria
Key inclusion criteria (4 listed)
- High-risk postoperative patients
- Patients treated in Intensive Care Unit of Emergency Department or Surgery Unit in Cipto Mangunkusumo General Hospital
- Age >18 years old
- Patients or family give written consent to follow the study
Key exclusion criteria (11 listed)
- Patients with late trimester-pregnancy when admitted to ICU
- Patients undergo cardiac surgery
- Patients with gastrointestinal disorders requiring routine therapy
- Patients undergo surgery involving bowels
- Patients undergo surgical treatment for burn
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
I-FABP plasma level
Time frame: During admission
I-FABP plasma level is measured during admission and 24 hours after. I-FABP plasma level during admission is used as the data, while the 24 hours after admission is used to evaluate any bowel injury during treatment in ICU.
I-FABP plasma level
Time frame: 24 hours after admission
I-FABP plasma level is measured during admission and 24 hours after. I-FABP plasma level during admission is used as the data, while the 24 hours after admission is used to evaluate any bowel injury during treatment in ICU.
Vasopressor dose
Time frame: During surgery (intraoperative period)
Mean dose of norepinephrine (mcg/kg/min) used during intraoperative period. It is measured proportionally to the duration of use based on anesthesia record.
SOFA score
Time frame: During admission in ICU (postoperative period)
Score used to evaluate patients' status during treatment in ICU and to determine the severity of organ dysfunction. It is measured during patients' admission to ICU
Fluid balance
Time frame: During surgery (intraoperative period)
The net between fluid output and input during intraoperative period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
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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.
Aldy Heriwardito, MD principal investigator
Fakultas Kedokteran 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 Gastrointestinal Dysfunction and Surgery, run by Aldy Heriwardito 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 4 inclusion and 11 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 19 May 2023. 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 Aldy Heriwardito, MD (3143336 ext. 6221, aldy.heriwardito@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
I-FABP plasma level (time frame: During admission). The study lists 5 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 19 May 2023.