Clinical trial NCT05867043: Postoperative Gastrointestinal Dysfunction After High Risk Surgery
Official title: Postoperative Gastrointestinal Dysfunction After High Risk Surgery: A Prospective Study in Adult Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastrointestinal Dysfunction
Surgery
Postoperative Complications
Keywords: gastrointestinal dysfunction
high risk surgery
postoperative
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2023-05-19
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: I-FABP plasma level
timeFrame: During admission
measure: I-FABP plasma level
timeFrame: 24 hours after admission
measure: Vasopressor dose
timeFrame: During surgery (intraoperative period)
measure: SOFA score
timeFrame: During admission in ICU (postoperative period)
measure: Fluid balance
timeFrame: During surgery (intraoperative period)
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo Central National Hospital
state: Jakarta
Study officials:
affiliation: Fakultas Kedokteran Universitas Indonesia
name: Aldy Heriwardito, MD
role: PRINCIPAL_INVESTIGATOR
References: