Postoperative Gastrointestinal Dysfunction After High Risk Surgery

Recruiting

• Conditions: Gastrointestinal Dysfunction; Surgery; Postoperative Complications

• Registration Number: NCT05867043
• Lead Sponsor: Aldy Heriwardito

Brief 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

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 Timeline

• Study Start: 2023-01-23
• Study First Submitted: 2023-04-18
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-10
• Last Update Submitted: 2023-05-10
• Study First Posted: 2023-05-19
• Last Update Posted: 2023-05-19
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SOFA score	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
I-FABP plasma level	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	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.
Fluid balance	During surgery (intraoperative period)	The net between fluid output and input during intraoperative period.

Trial Locations

Locations (1)

Cipto Mangunkusumo Central National Hospital; 🇮🇩 Jakarta Pusat, Jakarta, Indonesia