INtestinal Failure, multiPle Organ Failure ANd CItrulline Assessment

Organ Failure, Multiple Clinical Trial

— IN-PANCIA  

Official title:

Clinical Evaluation of Gastro Intestinal Failure, Multiple Organ Failure and Levels of Citrulline in Critical Ill Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02520440
• Other study ID #: NP 1769/2014
• Status: Completed
• Phase: N/A
• First received: August 6, 2015
• Last updated: August 7, 2015
• Start date: September 2014
• Est. completion date: July 2015

Study information

• Verified date: August 2015
• Source: Azienda Ospedaliera Spedali Civili di Brescia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics CommitteeItaly: National Institute of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Citrulline
• Gastro Intestinal Failure
• Intra Abdominal Pressure
• Multiple Organ Failure
• Organ Failure, Multiple

Intervention

Biological:
• Monitoring of plasmatic levels of Citrulline
Measured plasma amino-acids levels

Device:
• Intra-abdominal pressure monitoring
Intra-abdominal Hypertension is defined as an average pressure of the day = 12 mmHg; abdominal compartment syndrome is defined as a sustained (minimally two standardized measurements, performed 1-6 h apart) increase in Intra-abdominal pressure above 20 mmHg with new onset organ failure.

Biological:
• Monitoring of plasmatic levels of Arginine and Glutamine
Measured plasma amino-acids levels

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Azienda Ospedaliera Spedali Civili di Brescia	Università degli Studi di Brescia

References & Publications (6)

Carlson GL, Dark P. Acute intestinal failure. Curr Opin Crit Care. 2010 Aug;16(4):347-52. doi: 10.1097/MCC.0b013e328339fabe. Review. — View Citation

Malbrain ML, Cheatham ML, Kirkpatrick A, Sugrue M, Parr M, De Waele J, Balogh Z, Leppäniemi 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. Epub 2006 Sep 12. — View 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. Review. — View 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. — View 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. Review. — View 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. Erratum in: Crit Care. 2008;12(6):435. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	to investigate if increasing of intra abdominal pressure is associated with a clinical diagnosis of Gastro Intestinal Failure, and may predict the development of Multiple Organ Failure. Intra-abdominal Hypertension (IAH) is defined as an average IAP of the day = 12 mmHg; abdominal compartment syndrome (ACS) is defined as a sustained (minimally two standardized measurements, performed 1-6 h apart) increase in IAP above 20 mmHg with new onset organ failure.	within the first 30 days after admission in intensive care unit	Yes
Secondary	Correlation between levels of Arginine and Glutamine in patients with Gastro Intestinal Failure and Multiple Organ Failure	to investigate if plasma Arginine and Glutamine levels are associated with a clinical diagnosis of Gastro Intestinal Failure, and may predict the development of Multiple Organ Failure.	within the first 30 days after admission in intensive care unit	Yes