Postoperative Gastrointestinal Dysfunction After High Risk Surgery

Study Overview
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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.

Official Title
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Postoperative Gastrointestinal Dysfunction After High Risk Surgery: A Prospective Study in Adult Intensive Care Unit

Conditions
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Gastrointestinal Dysfunction, Surgery, Postoperative Complications

Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experience gastrointestinal dysfunction<br>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<br>Did not experience gastrointestinal dysfunction = AGI score <2 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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 | During admission in ICU (postoperative period) | 
| Fluid balance | The net between fluid output and input during intraoperative period. | During surgery (intraoperative period) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative, gastrointestinal dysfunction, high risk surgery