Critical IllnessiSOFANCT02613000
Intestinal-Specific Organ Function Assessment (iSOFA Study)
An observational study of Critical Illness and Multiple Organ Failure, run by University of Tartu at 1 site in Estonia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Multiple Organ Failure
- How many people
- 544 participants
- Where
- 1 siteEstonia
- Study dates
- Apr 2015to Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Multicenter Cohort Study on Prognostic Value of Gastrointestinal Symptoms and Intestinal-specific Biomarkers in Prediction of Outcome of Intensive Care Patients
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:
Read more
- 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.
Read the detailed description
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.
- 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.
- 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
- 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.
- Intestinal-specific plasma and urinary markers are good to excellent predictors of outcome in critically ill patients.
- Best prediction is achieved by combination of GI symptoms, IAP and plasma markers.
- 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 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.
- What is the predictive capability of gastrointestinal symptoms, IAP and AGI grades in intensive care patients?
- Does the use of the AGI grades or a new AGI score based on GI symptoms alone or in combination with IAP improve the predictive capability of the SOFA score in the intensive care patients? Part B.
- What is the relationship between the intestinal-specific markers and the disease severity of the organ dysfunction, as described with the APACHE and the SOFA score?
- What is the predictive value of the intestinal-specific markers in predicting ICU-, 28 days and 90 days all-cause mortality, ICU and hospital length of stay, and duration of mechanical ventilation?
- Is there a correlation between the intestinal-specific markers and the gastrointestinal signs and symptoms?
- Is the predictive value of the intestinal specific markers higher compared to the GI symptoms, IAP and AGI grades in predicting ICU-, 28 days and 90 days all-cause mortality, ICU and hospital length of stay, and duration of mechanical ventilation?
- Does the addition of the intestinal-specific plasma and urinary markers increase the predictive value of the SOFA score in predicting outcome?
- Is the combination of the intestinal-specific markers with the GI symptoms, IAP and AGI grades better in predicting outcome compared to two individual items?
- What in these comparisons is the best marker or combination of markers?
Methods/design
- Study design, setting and patient population This is a prospective multicenter cohort study where 500 consecutive adult patients admitted to the intensive care unit will be monitored for gastrointestinal symptoms, IAP and AGI grades. Of these 500 patients, 200 patients will be included in part B.
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.
- Conditions
- Critical Illness, Multiple Organ Failure
- Being tested
- No intervention
- Medical subject headings
- Critical Illness, Multiple Organ Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| All enrolled patients/Group A | 500 consecutive adult patients will be enrolled in Part A (clinical data) Receives: 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) Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause mortality
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2015 (estimated)
- Study startApr 2015
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 544 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tartu
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital, Insel Gruppe AG, University Hospital Bern, Vienna General Hospital
- Responsible party
- Principal investigator, Annika Reintam Blaser, University of Tartu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02613000
- Sponsor's protocol ID
- iSOFA Study
- Acronym
- iSOFA
- Status last verified
- Apr 2019
- First submitted
- 18 Nov 2015
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 34620335Reintam 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.
PubMed 34358839
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter Cohort Study on Prognostic Value of Gastrointestinal Symptoms and Intestinal-specific Biomarkers in Prediction of Outcome of Intensive Care Patients
- ClinicalTrials.gov ID
- NCT02613000
- Acronym / sponsor ID
- iSOFA / iSOFA Study
- Conditions
- Critical Illness, Multiple Organ Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 544 participants (actual)
- Lead sponsor
- University of TartuUniversity, hospital or other
- Collaborators
- Karolinska University Hospital, Insel Gruppe AG, University Hospital Bern, Vienna General Hospital
- Study start
- Apr 2015 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 24 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
- 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.
- 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
- 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.
- Intestinal-specific plasma and urinary markers are good to excellent predictors of outcome in critically ill patients.
- Best prediction is achieved by combination of GI symptoms, IAP and plasma markers.
- 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 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.
- What is the predictive capability of gastrointestinal symptoms, IAP and AGI grades in intensive care patients?
- Does the use of the AGI grades or a new AGI score based on GI symptoms alone or in combination with IAP improve the predictive capability of the SOFA score in the intensive care patients? Part B.
- What is the relationship between the intestinal-specific markers and the disease severity of the organ dysfunction, as described with the APACHE and the SOFA score?
- What is the predictive value of the intestinal-specific markers in predicting ICU-, 28 days and 90 days all-cause mortality, ICU and hospital length of stay, and duration of mechanical ventilation?
- Is there a correlation between the intestinal-specific markers and the gastrointestinal signs and symptoms?
- Is the predictive value of the intestinal specific markers higher compared to the GI symptoms, IAP and AGI grades in predicting ICU-, 28 days and 90 days all-cause mortality, ICU and hospital length of stay, and duration of mechanical ventilation?
- Does the addition of the intestinal-specific plasma and urinary markers increase the predictive value of the SOFA score in predicting outcome?
- Is the combination of the intestinal-specific markers with the GI symptoms, IAP and AGI grades better in predicting outcome compared to two individual items?
- What in these comparisons is the best marker or combination of markers?
Methods/design
- Study design, setting and patient population This is a prospective multicenter cohort study where 500 consecutive adult patients admitted to the intensive care unit will be monitored for gastrointestinal symptoms, IAP and AGI grades. Of these 500 patients, 200 patients will be included in part B.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| All enrolled patients/Group A | – | Other: No intervention500 consecutive adult patients will be enrolled in Part A (clinical data) |
| Patients with blood and urine sampling/Group B | – | Other: No interventionPatients 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention | Other | All enrolled patients/Group A, Patients with blood and urine sampling/Group B |
Primary outcome
all-cause mortality
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Derived from this study: PubMed 34620335Padar 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.
- Derived from this study: PubMed 34358839Reintam 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Multiple Organ Failure, run by University of Tartu at 1 site in Estonia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all-cause mortality (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02613000, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.