INtestinal Failure, multiPle Organ Failure ANd CItrulline Assessment (IN-PANCIA)

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Status: Completed

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

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

Study type: Observational

Funder types: Other

Identifiers

NCT02520440

NP 1769/2014

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

42 participants in 2 patient groups

GIF and/or MOF patients

Description:

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.

Treatment:

Biological: Monitoring of plasmatic levels of Citrulline

Device: Intra-abdominal pressure monitoring

Biological: Monitoring of plasmatic levels of Arginine and Glutamine

Controls

Description:

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.

Treatment:

Biological: Monitoring of plasmatic levels of Citrulline

Device: Intra-abdominal pressure monitoring

Biological: Monitoring of plasmatic levels of Arginine and Glutamine