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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:
Duration of the study: for the individual patient 7 days and follow-up of 90 days Primary study outcome: 28 and 90 days all-cause mortality Secondary outcomes: ICU and hospital mortality, ICU length of stay, hospital length of stay, duration of mechanical ventilation, multiple organ failure as a cause of mortality, plasma and urinary levels of intestinal fatty-acid binding protein (I-FABP), citrulline, ileal lipid binding protein (ILBP), and D-lactate in general cohort of intensive care patients.
Full description
Objectives
Hypothesis
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 admission. Standard treatment is implemented; no additional interventions solely for the study will be performed. Waived consent is expected.
Part B. Blood and urinary samples for intestinal-specific laboratory markers will be drawn once daily from 200 patients enrolled in Part A, and analyzed in addition to standard clinical and laboratory data. First blood sample will be taken at admission to the intensive care unit. Informed consent will therefore be obtained from the patient or the next of kin after blood and urine sampling (delayed consent).
Research questions Part A.
Methods/design
All consecutive adult critically ill patients (25 to 50 patients for each study site) in need for intensive care admission during maximum 6 weeks.
The study will consist of three phases:
Screening assessment, documentation of admission parameters;
Study period of 7 days for the individual patient;
Follow-up period of 90 days.
Study sites and the duration of the study The study will be conducted in ICUs of both university teaching hospitals and general (non-academic) hospitals. 20 ICUs from different countries will be invited and expected to participate, and each site is expected to enrol 25 to 50 patients during the maximum period of 6 weeks.
For individual patient the study period is 7 days or till ICU discharge and follow-up of 90 days.
Enrollment
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Inclusion and exclusion criteria
Part A Inclusion criteria
Part B Inclusion criteria
Exclusion criteria
544 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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