CitrullineIN-PANCIANCT02520440
INtestinal Failure, multiPle Organ Failure ANd CItrulline Assessment
An observational study of Citrulline and Organ Failure, Multiple, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Citrulline, Organ Failure, Multiple, Gastro Intestinal Failure
- What is being tested?
- Monitoring of plasmatic levels of Citrulline, Intra-abdominal pressure monitoring and Monitoring of plasmatic levels of Arginine and Glutamine
- Type of treatment
- Medical device
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted in ICU
Who may be able to join
- Intensive Care Unit stay of at least 48 hours
Who cannot join
- 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.
About this study
Official title: Clinical Evaluation of Gastro Intestinal Failure, Multiple Organ Failure and Levels of Citrulline in Critical Ill Patients
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.
Read more
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.
- Being tested
- Monitoring of plasmatic levels of Citrulline, Intra-abdominal pressure monitoring, Monitoring of plasmatic levels of Arginine and Glutamine
- Keywords
- Citrulline, GIF, MOF, Calprotectina, intraabdominal pressure
- Medical subject headings
- Multiple Organ Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| GIF and/or MOF patients | 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. Receives: Biological: Monitoring of plasmatic levels of Citrulline; Device: Intra-abdominal pressure monitoring; Biological: Monitoring of plasmatic levels of Arginine and Glutamine | |
| Controls | 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. Receives: Biological: Monitoring of plasmatic levels of Citrulline; Device: Intra-abdominal pressure monitoring; Biological: Monitoring of plasmatic levels of Arginine and Glutamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of Gastro Intestinal Failure, defined as the presence of three or more gastro-intestinal symptoms; and Multiple Organ Failure measured by SOFA score
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)
Measured: within the first 30 days after admission in intensive care unit
Secondary outcomes (2)
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
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.
Measured: within the first 30 days after admission in intensive care unit
Correlation between levels of Arginine and Glutamine in patients with Gastro Intestinal Failure and Multiple Organ Failure
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.
Measured: within the first 30 days after admission in intensive care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2015 (estimated)
- Study startSep 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for CitrullineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Sponsor type
- University, hospital or other
- Collaborators
- Università degli Studi di Brescia
- Responsible party
- Principal investigator, Dr. Nazzareno Fagoni, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Investigators
- Nazzareno Fagoni, MD, Principal investigator, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02520440
- Sponsor's protocol ID
- NP 1769/2014
- Acronym
- IN-PANCIA
- Status last verified
- Aug 2015
- First submitted
- 6 Aug 2015
- Last updated
- 11 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Carlson GL, Dark P. Acute intestinal failure. Curr Opin Crit Care. 2010 Aug;16(4):347-52. doi: 10.1097/MCC.0b013e328339fabe.
PubMed 20489609Piton G, Manzon C, Cypriani B, Carbonnel F, Capellier G. Acute intestinal failure in critically ill patients: is plasma citrulline the right marker? Intensive Care Med. 2011 Jun;37(6):911-7. doi: 10.1007/s00134-011-2172-x. Epub 2011 Mar 12.
PubMed 21400011Reintam A, Parm P, Kitus R, Starkopf J, Kern H. Gastrointestinal failure score in critically ill patients: a prospective observational study. Crit Care. 2008;12(4):R90. doi: 10.1186/cc6958. Epub 2008 Jul 14.
PubMed 18625051Malbrain ML, Cheatham ML, Kirkpatrick A, Sugrue M, Parr M, De Waele J, Balogh Z, Leppaniemi A, Olvera C, Ivatury R, D'Amours S, Wendon J, Hillman K, Johansson K, Kolkman K, Wilmer A. Results from the International Conference of Experts on Intra-abdominal Hypertension and Abdominal Compartment Syndrome. I. Definitions. Intensive Care Med. 2006 Nov;32(11):1722-32. doi: 10.1007/s00134-006-0349-5. Epub 2006 Sep 12.
PubMed 16967294Puleo F, Arvanitakis M, Van Gossum A, Preiser JC. Gut failure in the ICU. Semin Respir Crit Care Med. 2011 Oct;32(5):626-38. doi: 10.1055/s-0031-1287871. Epub 2011 Oct 11.
PubMed 21989698Piton G, Manzon C, Monnet E, Cypriani B, Barbot O, Navellou JC, Carbonnel F, Capellier G. Plasma citrulline kinetics and prognostic value in critically ill patients. Intensive Care Med. 2010 Apr;36(4):702-6. doi: 10.1007/s00134-010-1751-6.
PubMed 20084502
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Gastro Intestinal Failure, Multiple Organ Failure and Levels of Citrulline in Critical Ill Patients
- ClinicalTrials.gov ID
- NCT02520440
- Acronym / sponsor ID
- IN-PANCIA / NP 1769/2014
- Keywords
- Citrulline, GIF, MOF, Calprotectina, intraabdominal pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaUniversity, hospital or other
- Collaborators
- Università degli Studi di Brescia
- Study start
- Sep 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 11 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GIF and/or MOF patients | – | Biological: Monitoring of plasmatic levels of Citrulline, Device: Intra-abdominal pressure monitoring, Biological: Monitoring of plasmatic levels of Arginine and GlutamineDevelopment 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 | – | Biological: Monitoring of plasmatic levels of Citrulline, Device: Intra-abdominal pressure monitoring, Biological: Monitoring of plasmatic levels of Arginine and Glutaminepatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted in ICU
Key inclusion criteria (1 listed)
- Intensive Care Unit stay of at least 48 hours
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monitoring of plasmatic levels of CitrullineMeasured plasma amino-acids levels | Biological | Controls, GIF and/or MOF patients |
| Intra-abdominal pressure monitoringIntra-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. | Device | Controls, GIF and/or MOF patients |
| Monitoring of plasmatic levels of Arginine and GlutamineMeasured plasma amino-acids levels | Biological | Controls, GIF and/or MOF patients |
Primary outcome
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)
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2015.
- Background: PubMed 20489609Carlson GL, Dark P. Acute intestinal failure. Curr Opin Crit Care. 2010 Aug;16(4):347-52. doi: 10.1097/MCC.0b013e328339fabe.
- Background: PubMed 21400011Piton G, Manzon C, Cypriani B, Carbonnel F, Capellier G. Acute intestinal failure in critically ill patients: is plasma citrulline the right marker? Intensive Care Med. 2011 Jun;37(6):911-7. doi: 10.1007/s00134-011-2172-x. Epub 2011 Mar 12.
- Background: PubMed 18625051Reintam A, Parm P, Kitus R, Starkopf J, Kern H. Gastrointestinal failure score in critically ill patients: a prospective observational study. Crit Care. 2008;12(4):R90. doi: 10.1186/cc6958. Epub 2008 Jul 14.
- Background: PubMed 16967294Malbrain ML, Cheatham ML, Kirkpatrick A, Sugrue M, Parr M, De Waele J, Balogh Z, Leppaniemi A, Olvera C, Ivatury R, D'Amours S, Wendon J, Hillman K, Johansson K, Kolkman K, Wilmer A. Results from the International Conference of Experts on Intra-abdominal Hypertension and Abdominal Compartment Syndrome. I. Definitions. Intensive Care Med. 2006 Nov;32(11):1722-32. doi: 10.1007/s00134-006-0349-5. Epub 2006 Sep 12.
- Background: PubMed 21989698Puleo F, Arvanitakis M, Van Gossum A, Preiser JC. Gut failure in the ICU. Semin Respir Crit Care Med. 2011 Oct;32(5):626-38. doi: 10.1055/s-0031-1287871. Epub 2011 Oct 11.
- Background: PubMed 20084502Piton G, Manzon C, Monnet E, Cypriani B, Barbot O, Navellou JC, Carbonnel F, Capellier G. Plasma citrulline kinetics and prognostic value in critically ill patients. Intensive Care Med. 2010 Apr;36(4):702-6. doi: 10.1007/s00134-010-1751-6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nazzareno Fagoni, MD principal investigator
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Questions about this trial
What is this clinical trial studying?
An observational study of Citrulline and Organ Failure, Multiple, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02520440, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2015.