Clinical Trial: Intestinal-Specific Organ Function Assessment (iSOFA Study)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational



Official Title: Prospective, Multicenter Cohort Study on Prognostic Value of Gastrointestinal Symptoms and Intestinal-specific Biomarkers in Prediction of Outcome of Intensive Care Patients

Brief Summary:

Importance of gastrointestinal (GI) function in critically ill patients has been recognized, but until now there is no validated clinical tool to monitor GI dysfunction as part of multiple organ dysfunction syndrome (MODS). The general aim of current project is to develop a five grade score (0-4 points) for assessment of GI function similar to SOFA sub-scores used for assessment of other organ systems. 500 consecutive adult patients admitted to the intensive care unit will be monitored for gastrointestinal symptoms, intra-abdominal pressure (IAP) and acute gastrointestinal injury (AGI) grades [1]. In 200 patients from these, plasma and urinary levels of possible biochemical markers of intestinal injury will be assessed.

Objectives:

  • To determine the prognostic value of gastrointestinal symptoms alone and in combination with intra-abdominal pressure (IAP), and acute gastro-intestinal injury (AGI) grades in predicting the ICU-, 28 days and 90 days mortality of adult intensive care patients (Part A of the study)
  • To describe the blood and urine levels of biochemical markers of intestinal injury in general cohort of intensive care patients (Part B of the study).
  • To compare the prognostic values of the intestinal-specific plasma parameters (IFABP, citrulline, ILBP, and D-lactate) with the gastrointestinal symptoms, AGI grades, and the SOFA score in predicting of ICU-, 28 days and 90 days mortality of adult intensive care patients (Part B of the study) Study design: prospective, observational, multicenter study Patient population: All consecutive adult critically ill patients (25 to 50 patients for each study site, 500 patients in total) in need for intensive care admission during maximum 4 weeks of study period.