An observational study in Gastrointestinal Dysfunction, Surgery and Postoperative Complications, sponsored by Aldy Heriwardito. Recruiting at 1 site in Indonesia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-19.
Sponsored by Aldy Heriwardito · Observational
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
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.
1,233 studies on the registry are indexed under Postoperative Complications; 292 are open to participants now.
This study's planned enrollment of 66 is below the median of 254 across 519 observational studies indexed under Postoperative Complications.
Browse Postoperative Complications studies →Aldy Heriwardito is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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High-risk postoperative patients treated in Intensive Care Unit of Emergency Department or Surgery Unit in Cipto Mangunkusumo General Hospital who meet eligibility criteria
Exclusion Criteria:
Drop-out Criteria
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 = AGI score \<2
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: During admission in ICU (postoperative period)
Fluid balance
The net between fluid output and input during intraoperative period.
Time frame: During surgery (intraoperative period)
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