CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 42 enrolled
Drug / intervention
Monitoring of plasmatic levels of Citrulline +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02520440
NCT02520440N/ACompleted

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

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia·observational·Posted Aug 11, 2015·Updated Aug 11, 2015

In Brief

An observational study evaluating Monitoring of plasmatic levels of Citrulline, Intra-abdominal pressure monitoring, and 1 other intervention for Citrulline and 3 related conditions. Completed, enrolled 42 participants.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
Countries--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 11, 2015
Enrollment StartSep 1, 2014
Primary CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 10.9 years ago

Interventions

Monitoring of plasmatic levels of Citrullinebiological

Measured plasma amino-acids levels

Intra-abdominal pressure monitoringdevice

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.

Monitoring of plasmatic levels of Arginine and Glutaminebiological

Measured plasma amino-acids levels