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.

Detailed Summary:

Objectives

  1. 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.
  2. To describe the blood and urine levels of the intestinal-specific plasma parameters (I-FABP, citrulline, ILBP, and D-lactate) in general cohort of intensive care patients.
  3. To compare the prognostic values of the intestinal-specific plasma parameters (I-FABP, 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.

Hypothesis

  1. GI symptoms, alone or in combination with IAP, and AGI grades as defined by WGAP statement improve the predictive capability of the SOFA score in critically ill patients.
  2. Intestinal-specific plasma and urinary markers are good to excellent predictors of outcome in critically ill patients.
  3. Best prediction is achieved by combination of GI symptoms, IAP and plasma markers.
  4. A clinical score developed based on the data from this study can be combined with existing SOFA score and thereby the predictive value of the SOFA score will be improved.

To test these hypotheses, the study has two parts:

Part A. Clinical data and routine laboratory parameters of 500 consecutive patients will be collected for 7 days after ICU admi
Sponsor: University of Tartu

Current Primary Outcome: all-cause mortality [ Time Frame: 90 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Tartu

Dates:
Date Received: November 18, 2015
Date Started: April 2015
Date Completion: March 2018
Last Updated: October 24, 2016
Last Verified: October 2016