INtestinal Failure, multiPle Organ Failure ANd CItrulline Assessment

Completed

• Conditions: Intra Abdominal Pressure; Organ Failure, Multiple; Citrulline; Gastro Intestinal Failure
• Interventions: Biological: Monitoring of plasmatic levels of Citrulline; Device: Intra-abdominal pressure monitoring; Biological: Monitoring of plasmatic levels of Arginine and Glutamine

• Registration Number: NCT02520440
• Lead Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2015-08
• Study First Submitted: 2015-08-06
• Study First Submitted QC: 2015-08-07
• Last Update Submitted: 2015-08-07
• Study First Posted: 2015-08-11
• Last Update Posted: 2015-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GIF and/or MOF patients	Intra-abdominal pressure monitoring	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.
Controls	Monitoring of plasmatic levels of Citrulline	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.
Controls	Intra-abdominal pressure monitoring	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.
Controls	Monitoring of plasmatic levels of Arginine and Glutamine	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.
GIF and/or MOF patients	Monitoring of plasmatic levels of Citrulline	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.
GIF and/or MOF patients	Monitoring of plasmatic levels of Arginine and Glutamine	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.

Primary Outcome Measures

Name	Time	Method
Development of Gastro Intestinal Failure, defined as the presence of three or more gastro-intestinal symptoms; and Multiple Organ Failure measured by SOFA score	within the first 30 days after admission in intensive care unit	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)

Secondary Outcome Measures

Name	Time	Method
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	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.
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	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.