Postoperative Gastrointestinal Dysfunction After High Risk Surgery

NCT ID: NCT05867043

Last Updated: 2023-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

66 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-23

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Gastrointestinal Dysfunction Surgery Postoperative Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Did not experience gastrointestinal dysfunction

Did not experience gastrointestinal dysfunction = AGI score \<2

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aldy Heriwardito

OTHER

Sponsor Role lead

Responsible Party

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Aldy Heriwardito

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Aldy Heriwardito, MD

Role: PRINCIPAL_INVESTIGATOR

Fakultas Kedokteran Universitas Indonesia

Locations

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Cipto Mangunkusumo Central National Hospital

Jakarta Pusat, Jakarta Special Capital Region, Indonesia

Site Status RECRUITING

Countries

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Indonesia

Central Contacts

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Aldy Heriwardito, MD

Role: CONTACT

3143336 ext. 6221

Other Identifiers

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IndonesiaUAnes939

Identifier Type: -

Identifier Source: org_study_id

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