Postoperative Gastrointestinal Dysfunction After High Risk Surgery

NCT05867043 | Unknown DMC

• 1 other identifier: IndonesiaUAnes939
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

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

Conditions

Gastrointestinal Dysfunction; Surgery; Postoperative Complications

Keywords

gastrointestinal dysfunction; high risk surgery; postoperative

Outcome Measures

Primary Outcomes (5)

• 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)

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aldy Heriwardito: lead

Study Sites (1)

Cipto Mangunkusumo Central National Hospital

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Intestinal fatty-acid binding protein (I-FAPB) is expressed in epithelial cells of the mucosal layer of the small intestine tissue.

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Aldy Heriwardito, MD

  Fakultas Kedokteran Universitas Indonesia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aldy Heriwardito, MD

CONTACT

3143336; aldy.heriwardito@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: May 19, 2023
• Study Start: January 23, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 19, 2023

Record last verified: 2023-05

Locations

ID (1)