Intestinal-Specific Organ Function Assessment (iSOFA Study)

NCT02613000 | Completed DMC

• 1 other identifier: iSOFA Study
• Study Type: observational
• Target: 544
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Critical Illness; Multiple Organ Failure

Outcome Measures

Primary Outcomes (1)

• all-cause mortality

  90 days

Study Arms (2)

All enrolled patients/Group A

500 consecutive adult patients will be enrolled in Part A (clinical data)

Other: No intervention

Patients with blood and urine sampling/Group B

Patients with informed consent signed (anticipated 200 out of 500 patients) will participate in Part A (clinical data) and B (intestinal-specific biomarkers from blood and urine)

Other: No intervention

Interventions

No intervention OTHER

All enrolled patients/Group A; Patients with blood and urine sampling/Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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 6 weeks of study period.

You may qualify if:

• Admission to ICU during the study period (the patients already in the ICU at the time the study starts will not be included)

You may not qualify if:

• Age \<18 years
• Restriction of care at admission (i.e any limitation of intensive care measures)
• Readmission 7 or more days after initial admission to ICU
• Admission to ICU during the study period (the patients already in the ICU at the time the study starts will not be included)
• Age at least 18 years
• Signed informed consent by patient or next of kin or legal representative for blood sampling.
• Age \<18 years
• Restriction of care at admission (i.e any limitation of intensive care measures)
• Readmission 7 or more days after initial admission to ICU
• Absence of signed informed consent

Sponsors & Collaborators

• University of Tartu: lead
• Karolinska University Hospital: collaborator
• Insel Gruppe AG, University Hospital Bern: collaborator
• Vienna General Hospital: collaborator

Study Sites (1)

Tartu University Hospital

Tartu, 51014, Estonia

Location

Related Publications (2)

• Padar M, Starkopf J, Starkopf L, Forbes A, Hiesmayr M, Jakob SM, Rooijackers O, Wernerman J, Ojavee SE, Reintam Blaser A. Enteral nutrition and dynamics of citrulline and intestinal fatty acid-binding protein in adult ICU patients. Clin Nutr ESPEN. 2021 Oct;45:322-332. doi: 10.1016/j.clnesp.2021.07.026. Epub 2021 Aug 3.

  PMID: 34620335 DERIVED

• Reintam Blaser A, Padar M, Mandul M, Elke G, Engel C, Fischer K, Giabicani M, Gold T, Hess B, Hiesmayr M, Jakob SM, Loudet CI, Meesters DM, Mongkolpun W, Paugam-Burtz C, Poeze M, Preiser JC, Renberg M, Rooijackers O, Tamme K, Wernerman J, Starkopf J. Development of the Gastrointestinal Dysfunction Score (GIDS) for critically ill patients - A prospective multicenter observational study (iSOFA study). Clin Nutr. 2021 Aug;40(8):4932-4940. doi: 10.1016/j.clnu.2021.07.015. Epub 2021 Jul 18.

  PMID: 34358839 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

In patients included in Part B, approx. 7 ml of arterial or venous blood will be drawn each morning during the study period. Standard EDTA containing vacutainers are used for blood sampling and placed into ice until centrifugation. Blood will be centrifuged at 4 degrees by study nurse or central laboratory of the study site, after which plasma will be separated and stored at -80 degrees in eppendorf vials containing 1 ml of plasma, marked and labelled with study code numbers. 10 ml of urine will be sampled each morning Timing of admission day sample at time of plasma sampling (6 AM) from the collection bag and stored at -80 degrees. 2 eppendorf test-tubes containing 1 ml are used for urine sampling. Samples for citrulline measurements will be shipped to University of East Anglia, Norwich, United Kingdom and other samples to Maastricht University Medical Center, Netherland, for biochemical analyses to be performed.

MeSH Terms

Conditions

Critical Illness; Multiple Organ Failure

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: November 18, 2015
• First Posted: November 24, 2015
• Study Start: April 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: April 16, 2019

Record last verified: 2019-04

Locations

ES (1)