MedTrace Logo

INtestinal Failure, multiPle Organ Failure ANd CItrulline Assessment

NCT02520440 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 42

Last updated 2015-08-11

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Università degli Studi di Brescia

    collaborator OTHER

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

    lead OTHER

Principal Investigators

  • Nazzareno Fagoni, MD · Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2015-07-31
Completion
2015-07-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02520440 on ClinicalTrials.gov