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Completed

NCT Number: NCT02520440

INtestinal Failure, multiPle Organ Failure ANd CItrulline Assessment

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.

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Key information

Conditions

Citrulline Gastro Intestinal Failure Intra Abdominal Pressure Multiple Organ Failure Organ Failure, Multiple Pathologic Processes Pathological Conditions, Signs and Symptoms Shock

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Monitoring of plasmatic levels of Citrulline

Biological

Measured plasma amino-acids levels

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.

Monitoring of plasmatic levels of Arginine and Glutamine

Biological

Measured plasma amino-acids levels

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

    Time frame: 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 outcomes

  1. 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

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Other

Collaborators

  • Università degli Studi di Brescia

Registry information

Official study title

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

Acronym: IN-PANCIA

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 11, 2015
Registry last updated
Aug 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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