Clinical TrialID 5440
INtestinal Failure, multiPle Organ Failure ANd CItrulline Assessment
NCT02520440
Citrulline|Organ Failure, Multiple|Gastro Intestinal Failure|Intra Abdominal Pressure
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 5440
- Evidence Id
- 5440
- Core Evidence Id
- 5440
- Source Clinical Trial Id
- 5426
- Herb2 Clinical Trial Id
- HBCT005426
- Nct Id
- NCT02520440
- Title
- INtestinal Failure, multiPle Organ Failure ANd CItrulline Assessment
- Status
- Completed
- Phase
- Study Result
- No
- Study Condition
- Citrulline|Organ Failure, Multiple|Gastro Intestinal Failure|Intra Abdominal Pressure
- Study Type
- Observational
- Study Design
- Observational Model: |Time Perspective: p
- Intervention
- BIOLOGICAL: Monitoring of plasmatic levels of Citrulline|DEVICE: Intra-abdominal pressure monitoring|BIOLOGICAL: Monitoring of plasmatic levels of Arginine and Glutamine
- Intervention Allocation
- Intervention Model
- Intervention Mask
- Intervention Purpose
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 42
- Outcome Measure
- Development of Gastro Intestinal Failure, defined as the presence of three or more gastro-intestinal symptoms; and Multiple Organ Failure measured by SOFA score, to investigate if plasma citrulline levels are associated with a clinical diagnosis of Gastro Intestinal Failure, and may predict the development of Multiple Organ Failure. Gastrointestinal Failure is defined as the presence of three or more coincident GI symptoms (igh gastric residual volumes (GRV) = maximum GRV above 500 ml at least once. Absent bowel sounds (BS) = BS not heard on careful auscultation. Vomiting/Regurgitation= visible vomiting or regurgitation in any amount. Diarrhoea = loose of liquid stool three or more times per day. Bowel distension= suspected or radiologically confirmed bowel dilatation in any bowel segment. GI bleeding= visible appearance of blood in vomit, nasogastric aspirate or stool.). MOF was defined as the failure of two or more organs or system according to the Sequential Organ Failure Assessment (SOFA), within the first 30 days after admission in intensive care unit
- Sponsor Collaborator
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia|Università degli Studi di Brescia
- Funded By
- OTHER
- Location
- Other Id
- NP 1769/2014
- Start Date
- 2014-09
- Primary Completion Date
- 2015-07
- Completion Date
- 2015-07
- First Posted
- 2015-08-11
- Results First Posted
- Last Update Posted
- 2015-08-11
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT02520440
- Title Cn
- Title En
- INtestinal Failure, multiPle Organ Failure ANd CItrulline Assessment
- Bilingual Status
- semi_complete