Clinical trial NCT02520440: INtestinal Failure, multiPle Organ Failure ANd CItrulline Assessment
Official title: Clinical Evaluation of Gastro Intestinal Failure, Multiple Organ Failure and Levels of Citrulline in Critical Ill Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Citrulline
Organ Failure, Multiple
Gastro Intestinal Failure
Intra Abdominal Pressure
Keywords: Citrulline
GIF
MOF
Calprotectina
intraabdominal pressure
Lead sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Sponsor class: OTHER
Collaborators: name: Università degli Studi di Brescia
First posted: 2015-08-11
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted in ICU

Brief summary: The gastrointestinal dysfunction occurs frequently during the intensive care unit (ICU) stay and is associated with a worse prognosis.

The gastrointestinal failure (GIF) is diagnosed based on symptoms such as bowel distension, ileus, diarrhea, digestive bleeding, or intestinal ischemia. A GIF score based on has been demonstrated to be correlated with outcome, with higher scores indicating higher risk of death. However, GIF may be occult or clinical signs can go undetected in critically ill patients due to the frequent use of analgesic, sedative or neuromuscular blocking agents, acute neurologic diseases, or delirium.

Citrulline is a potential biomarker for small bowel function in critically ill patients with maintained renal function. Normal plasma citrulline levels (12-55 µmol/L) are determined by the balance between gut synthesis and kidney degradation.

GIF is involved in the pathogenesis of multiple organ dysfunctions and failures (MOF) through various mechanisms, and it is often associated with high intra-abdominal pressure (IAP). IAP greater than 12 mmHg, may lead to abdominal compartment syndrome (ACS) and MOF, including cardiac, respiratory and kidney failure. Studies have suggested that GIF can be the consequence rather than the cause of MOF.

The aim of this study is to investigate if plasma citrulline levels is associated with a clinical diagnosis of GIF, and may predict the development of MOF.


Eligibility criteria: Inclusion Criteria:

- Intensive Care Unit stay of at least 48 hours

Exclusion Criteria:

* Intensive Care Unit stay less than 48 hours
* abdominal trauma or surgery in the last 6 weeks
* inflammatory bowel disease
* a body mass index (BMI) ≥35
* terminal condition.

Primary outcomes:
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
timeFrame: within the first 30 days after admission in intensive care unit
Secondary outcomes:
measure: Correlation between intra abdominal hypertension (defined as an average of intra-abdominal pressure of the day ≥ 12 mmHg), and development of Gastro Intestinal Failure and Multiple Organ Failure
timeFrame: within the first 30 days after admission in intensive care unit
measure: Correlation between levels of Arginine and Glutamine in patients with Gastro Intestinal Failure and Multiple Organ Failure
timeFrame: within the first 30 days after admission in intensive care unit
Other outcomes:
Locations:
Study officials:
affiliation: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
name: Nazzareno Fagoni, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carlson GL, Dark P. Acute intestinal failure. Curr Opin Crit Care. 2010 Aug;16(4):347-52. doi: 10.1097/MCC.0b013e328339fabe.
citation: Piton G, Manzon C, Cypriani B, Carbonnel F, Capellier G. Acute intestinal failure in critically ill patients: is plasma citrulline the right marker? Intensive Care Med. 2011 Jun;37(6):911-7. doi: 10.1007/s00134-011-2172-x. Epub 2011 Mar 12.
citation: Reintam A, Parm P, Kitus R, Starkopf J, Kern H. Gastrointestinal failure score in critically ill patients: a prospective observational study. Crit Care. 2008;12(4):R90. doi: 10.1186/cc6958. Epub 2008 Jul 14.
citation: Malbrain ML, Cheatham ML, Kirkpatrick A, Sugrue M, Parr M, De Waele J, Balogh Z, Leppaniemi A, Olvera C, Ivatury R, D'Amours S, Wendon J, Hillman K, Johansson K, Kolkman K, Wilmer A. Results from the International Conference of Experts on Intra-abdominal Hypertension and Abdominal Compartment Syndrome. I. Definitions. Intensive Care Med. 2006 Nov;32(11):1722-32. doi: 10.1007/s00134-006-0349-5. Epub 2006 Sep 12.
citation: Puleo F, Arvanitakis M, Van Gossum A, Preiser JC. Gut failure in the ICU. Semin Respir Crit Care Med. 2011 Oct;32(5):626-38. doi: 10.1055/s-0031-1287871. Epub 2011 Oct 11.
citation: Piton G, Manzon C, Monnet E, Cypriani B, Barbot O, Navellou JC, Carbonnel F, Capellier G. Plasma citrulline kinetics and prognostic value in critically ill patients. Intensive Care Med. 2010 Apr;36(4):702-6. doi: 10.1007/s00134-010-1751-6.