Postoperative Gastrointestinal Dysfunction After High Risk Surgery

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05867043
• Other study ID #: IndonesiaUAnes939
• Status: Recruiting
• Start date: January 23, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2023
• Source: Indonesia University
• Contact: Aldy Heriwardito, MD
• Phone: 3143336
• Email: aldy.heriwardito[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Dysfunction
• Postoperative Complications
• Surgery

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo Central National Hospital	Jakarta Pusat	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Aldy Heriwardito

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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)
Primary	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)
Primary	Fluid balance	The net between fluid output and input during intraoperative period.	During surgery (intraoperative period)