Postoperative Gastrointestinal Dysfunction After High Risk Surgery

Aldy Heriwardito

Status: Enrolling

Conditions: Postoperative Complications; Surgery; Gastrointestinal Dysfunction

Study type: Observational

Funder types: Other

Identifiers

NCT05867043

IndonesiaUAnes939

Details and patient eligibility

About

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

Full 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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

66 participants in 2 patient groups

Experience gastrointestinal dysfunction

Description:

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

Description:

Did not experience gastrointestinal dysfunction = AGI score \<2