Postoperative Gastrointestinal Dysfunction After High Risk Surgery

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

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

Study Overview

• Status: Recruiting
• Conditions: Postoperative Complications; Surgery; Gastrointestinal Dysfunction

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 Type: Observational
• Enrollment (Anticipated): 66

Contacts and Locations

• Study Contact: Name: Aldy Heriwardito, MD; Phone Number: 6221 3143336; Email: aldy.heriwardito@gmail.com

Study Locations

• Indonesia
  • Jakarta
    • Jakarta Pusat, Jakarta, Indonesia, 10430
      • Recruiting
      • Cipto Mangunkusumo Central National Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

High-risk postoperative patients treated in Intensive Care Unit of Emergency Department or Surgery Unit in Cipto Mangunkusumo General Hospital who meet eligibility criteria

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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
Did not experience gastrointestinal dysfunction; Did not experience gastrointestinal dysfunction = AGI score <2

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Aldy Heriwardito
• Investigators: Principal Investigator: Aldy Heriwardito, MD, Fakultas Kedokteran Universitas Indonesia

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2023
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: April 18, 2023
• First Submitted That Met QC Criteria: May 10, 2023
• First Posted (Actual): May 19, 2023

Study Record Updates

• Last Update Posted (Actual): May 19, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: postoperative; gastrointestinal dysfunction; high risk surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: IndonesiaUAnes939

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No