INtestinal Failure, multiPle Organ Failure ANd CItrulline Assessment

NCT02520440 | Completed

• 1 other identifier: NP 1769/2014
• Study Type: observational
• Target: 42
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Citrulline; GIF; MOF; Calprotectina; intraabdominal pressure

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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

  within the first 30 days after admission in intensive care unit

• Correlation between levels of Arginine and Glutamine in patients with Gastro Intestinal Failure and Multiple Organ Failure

  within the first 30 days after admission in intensive care unit

Study Arms (2)

GIF and/or MOF patients

Development during the ICU stay of gastro-intestinal failure and/or multiple organ failure. Investigators performed in each patient monitoring of plasmatic levels of Citrulline, monitoring of plasmatic levels of Arginine and Glutamine, and intra-abdominal pressure monitoring.

Biological: Monitoring of plasmatic levels of Citrulline; Device: Intra-abdominal pressure monitoring; Biological: Monitoring of plasmatic levels of Arginine and Glutamine

Controls

patients admitted to ICU without gastrointestinal failure and/or multiple organ failure during the intensive care unit stay. Investigators performed in each patient monitoring of plasmatic levels of Citrulline, monitoring of plasmatic levels of Arginine and Glutamine, and intra-abdominal pressure monitoring.

Biological: Monitoring of plasmatic levels of Citrulline; Device: Intra-abdominal pressure monitoring; Biological: Monitoring of plasmatic levels of Arginine and Glutamine

Interventions

Monitoring of plasmatic levels of Citrulline BIOLOGICAL

Measured plasma amino-acids levels

Controls; GIF and/or MOF patients

Intra-abdominal pressure monitoring DEVICE

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.

Controls; GIF and/or MOF patients

Monitoring of plasmatic levels of Arginine and Glutamine BIOLOGICAL

Measured plasma amino-acids levels

Controls; GIF and/or MOF patients

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

Patients admitted in ICU

You may qualify if:

• \- Intensive Care Unit stay of at least 48 hours

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia: lead
• Università degli Studi di Brescia: collaborator

Related Publications (6)

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

  PMID: 20489609 BACKGROUND

• 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.

  PMID: 21400011 BACKGROUND

• 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.

  PMID: 18625051 BACKGROUND

• 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.

  PMID: 16967294 BACKGROUND

• 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.

  PMID: 21989698 BACKGROUND

• 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.

  PMID: 20084502 BACKGROUND

MeSH Terms

Conditions

Multiple Organ Failure

Interventions

Glutamine

Condition Hierarchy (Ancestors)

Shock; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Neutral

Study Officials

• Nazzareno Fagoni, MD

  Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 6, 2015
• First Posted: August 11, 2015
• Study Start: September 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: August 11, 2015

Record last verified: 2015-08