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Postoperative Gastrointestinal Dysfunction After High Risk Surgery

Sponsor
Aldy Heriwardito (Other)
Overall Status
Recruiting
CT.gov ID
NCT05867043
Collaborator
(none)
66
Enrollment
1
Location
11.2
Anticipated Duration (Months)
5.9
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    66 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Postoperative Gastrointestinal Dysfunction After High Risk Surgery: A Prospective Study in Adult Intensive Care Unit
    Actual Study Start Date :
    Jan 23, 2023
    Anticipated Primary Completion Date :
    Dec 31, 2023
    Anticipated Study Completion Date :
    Dec 31, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. I-FABP plasma level [During 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.

    2. 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.

    3. 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.

    4. 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

    5. Fluid balance [During surgery (intraoperative period)]

      The net between fluid output and input during intraoperative period.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cipto Mangunkusumo Central National Hospital Jakarta Pusat Jakarta Indonesia 10430

    Sponsors and Collaborators

    • Aldy Heriwardito

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Aldy Heriwardito, Principal Investigator, Indonesia University
    ClinicalTrials.gov Identifier:
    NCT05867043
    Other Study ID Numbers:
    • IndonesiaUAnes939
    First Posted:
    May 19, 2023
    Last Update Posted:
    May 19, 2023
    Last Verified:
    May 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Aldy Heriwardito, Principal Investigator, Indonesia University
    gastrointestinal dysfunction
    high risk surgery
    postoperative
    Additional relevant MeSH terms:
    Postoperative Complications

    Study Results

    No Results Posted as of May 19, 2023