Inflammatory ResponsePhase 4NCT01367223
Modulation of Systemic Inflammatory Response in Critically Ill Children After Glutamine Supplementation
A Phase 4 study testing solution of amino acids supplemented with glutamine and amino acids not supplemented with glutamine in people with Inflammatory Response and Multi-organ Failure, run by Hospital Sant Joan de Deu at 1 site in Spain.
Trial summary
This study aims to describe the use of glutamine supplementation in the modulation of inflammatory response in critically ill pediatric patients and to determine if this decrease leads to clinical improvement in morbidity and mortality in these patients. Read more about this study
- Who is it for?
- Ages 1 month to 14 years
- Conditions the study is for
- Inflammatory Response, Multi-organ Failure
- What is being tested?
- solution of amino acids supplemented with glutamine and amino acids not supplemented with glutamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2010to May 2013
- Phase
- Phase 4
- 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 1 month to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1. Patients aged between 1 month and 14 years who require parenteral nutrition according to the criteria of our unit and who comply with the following diagnoses:
- Local or systemic infection
- Post abdominal surgery
- Polytraumatised
- Parenteral nutrition indications:
- Intestinal resections
- Bowel obstruction or post-surgery
- Risk of intestinal ischaemia due to hypotension of hypoxaemia
Who cannot join
- Legal representative does not give consent.
- Patients with previous underlying diseases (renal impairment, hepatic impairment, inflammatory bowel disease, rheumatic diseases, metabolic diseases, immunocompromised).
- Mild liver impairment on admittance (hepatitis, colostasis).
- Post cardiac surgery with extracorporeal circulation.
- Patients referred from other hospitals with a clinical evolution of over 48 hours.
- Patients aged less than one month and over 14 years.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to describe the use of glutamine supplementation in the modulation of inflammatory response in critically ill pediatric patients and to determine if this decrease leads to clinical improvement in morbidity and mortality in these patients. Thus, these patients' diet could be supplemented with glutamine in order to improve their evolution.
Hypothesis:
Read more
From the data obtained in the study of the literature the investigators consider that:
Critically ill patients have a deficit of glutamine either because of an increase in its consumption or a decrease in its availability, and therefore blood glutamine levels are low.
Critically ill patients have elevated blood levels of pro-inflammatory substances (IL-6).
In these patients tissue lesion inhibitors (HSP-70) in the blood are decreased. The administration of glutamine supplements to these patients decreases oxidative stress due to the increase in HSP-70.
Inflammation inhibitory substances (IL-10) in the blood are decreased in these patients.
The administration of glutamine supplements in these patients increase IL-10 levels.
Glutamine supplements decrease the inflammatory response with a decrease in IL-6 levels.
Read the detailed description
Objective
This study aims to describe the use of glutamine supplementation in the modulation of inflammatory response in critically ill pediatric patients and to determine if this decrease leads to clinical improvement in morbidity and mortality in these patients. Thus, these patients' diet could be supplemented with glutamine in order to improve their evolution.
In recent years numerous studies have been conducted and published on the different factors, amongst them glutamine, that could modulate the inflammatory response of critically ill patients thus reducing the impact this response has and its progression to multi-organ failure.
Glutamine (Gln) is the most abundant amino acid in the body and is mainly synthesised in skeletal muscle. It is a non-essential amino acid that is produced is sufficient quantities in good states of health. Plasma levels are above 0.6 mmol/L, and 50% is found in the free form in plasma1. This amino acid not only acts as a source of energy but it is also involved in the synthesis of other amino acids, nucleotides, nucleic acids, sugars, amines, proteins and different biologically active molecules2. Other functions are: maintenance of the internal acid-base homeostasis, urea synthesis, glyconeogenesis, neurotransmission, and cell differentiation and proliferation. It is also the main energy substrate for the rapidly proliferating cells (enterocytes) and of multiple immune cells (macrophages, monocytes, lymphocytes). It also takes part in the protection of cells and tissues inducing expression of the heat shock proteins3.
In recent years, numerous studies have been performed to determine the effect of Gln, both by enteral and parenteral route, on the evolution of critically ill patients. These studies were conducted in animals and in humans, mainly adults. However, there is little reference in the literature to studies in children. The studies are based on the use of glutamine as a dietary supplement mainly in patients with neoplastic disease or inflammatory bowel disease. It has also been studied as a supplement in premature infants, but there are very few studies in critically ill children.
In the last year many studies have been published on the use of glutamine. The effect of glutamine supplementation on the intestinal mucosal barrier in rabbits under haemorrhagic shock was studied. Shock was induced by blood withdrawing from the femoral artery; the rabbits were randomised to three groups (control, low dose glutamine and high dose glutamine). Plasma levels of diamine oxidase and IL-8 were measured and a histological examination of the terminal ileum was performed. The results demonstrated a lower inflammatory and oxidative response in the rabbits who had received Gln supplementation37. Another study in rats measured the effect of the dipeptide Arginin - Gln on endothelial cell growth factor levels in retinal pigment epithelial cell cultures and on the inhibition of neovascularisation in oxygen-induced retinopathy. The authors concluded that they decreased with the administration of this dipeptide38. Another factor studied in critically ill patients was the oxidative activity measured as diamine oxidase activity and D-lactate content39. Protection against infection and decrease in insulin resistance in critically ill patients is still being studied 21,22, 32, 40, 41. Contradictory findings have been reported therefore new studies are required in systematic reviews.
- Conditions
- Inflammatory Response, Multi-organ Failure
- Being tested
- solution of amino acids supplemented with glutamine, amino acids not supplemented with glutamine
- Keywords
- inflammatory response, parenteral nutrition, glutamine, amino acid, pediatric, intensive care, systemic infection, abdominal surgery, polytraumatised, mortality, mean stay in the intensive care unit, occurrence of infections
- Medical subject headings
- Multiple Organ Failure, Hyperphagia, Toxemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
solution of amino acids supplemented with glutamineDietary supplement
Also called (Aminoven Infant® or Vamin®) with glutamine (Dipeptiven®)
parenteral nutrition by range of ages (recommendation from ESPGHAN and ESPEN:1 month to 3 years, 3 to 5 years, 6 to 12 and standard adult).Study Parenteral nutrition will be assessed the first 5 days.
amino acids not supplemented with glutamineDietary supplement
Also called (Aminoven Infant® or Vamin®) with glutamine (Dipeptiven®)
parenteral nutrition by range of ages (recommendation from ESPGHAN and ESPEN:1 month to 3 years, 3 to 5 years, 6 to 12 and standard adult).Study Parenteral nutrition will be assessed the first 5 days.
| Study group | Role | What they receive |
|---|---|---|
| solution of amino acids with glutamine | Experimental | Group 1 as the experimental group who will be administered a solution of amino acids supplemented with glutamine Receives: Dietary Supplement: solution of amino acids supplemented with glutamine |
| amino acids solution without glutamine | Other | Group 2:control group will be administered a solution of amino acids (Aminoven Infant® or Vamin®) not supplemented with glutamine Receives: Dietary Supplement: amino acids not supplemented with glutamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary study endpoint is to determine if there are any differences in inflammatory response in patients supplemented with glutamine compared to those who receive a standard diet without a glutamine supplement.
Laboratory measures: IL-6, IL-10, HSP-70
Measured: baseline-day2-day5
Secondary outcomes (1)
As secondary endpoints the clinical response of the two groups of patients was assessed with respect to the occurrence of infections, multi-organ failure, mean stay in the unit and mortality.
Measured: During 27 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2011 (estimated)
- Study startApr 2010
- Primary completionJul 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (44)Papers the sponsor has linked to this study.
- Other trials for Inflammatory ResponseStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Sant Joan de Deu
- Sponsor type
- University, hospital or other
- Collaborators
- Fundació Sant Joan de Déu, Spanish National Health System
- Responsible party
- Sponsor
- Investigators
- Iolanda Jordan, PhMD, Principal investigator, Hospital Sant Joan de Deu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01367223
- Sponsor's protocol ID
- UCIHSJD5
- Status last verified
- Sep 2013
- First submitted
- 3 Jun 2011
- Last updated
- 6 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Bracco D. Glutamine: a double edge sword in the intensive care unit? Crit Care Med. 2005 Nov;33(11):2692-4. doi: 10.1097/01.ccm.0000186750.06199.0f. No abstract available.
PubMed 16276205Yeh CL, Hsu CS, Yeh SL, Chen WJ. Dietary glutamine supplementation modulates Th1/Th2 cytokine and interleukin-6 expressions in septic mice. Cytokine. 2005 Sep 7;31(5):329-34. doi: 10.1016/j.cyto.2005.06.001.
PubMed 16026997Wischmeyer PE. Can glutamine turn off the motor that drives systemic inflammation? Crit Care Med. 2005 May;33(5):1175-8. doi: 10.1097/01.ccm.0000162686.28604.81. No abstract available.
PubMed 15891373Fuentes-Orozco C, Anaya-Prado R, Gonzalez-Ojeda A, Arenas-Marquez H, Cabrera-Pivaral C, Cervantes-Guevara G, Barrera-Zepeda LM. L-alanyl-L-glutamine-supplemented parenteral nutrition improves infectious morbidity in secondary peritonitis. Clin Nutr. 2004 Feb;23(1):13-21. doi: 10.1016/s0261-5614(03)00055-4.
PubMed 14757388Schulman AS, Willcutts KF, Claridge JA, O'Donnell KB, Radigan AE, Evans HL, McElearney ST, Hedrick TL, Lowson SM, Schirmer BD, Young JS, Sawyer RG. Does enteral glutamine supplementation decrease infectious morbidity? Surg Infect (Larchmt). 2006 Feb;7(1):29-35. doi: 10.1089/sur.2006.7.29.
PubMed 16509783Tubman TR, Thompson SW, McGuire W. Glutamine supplementation to prevent morbidity and mortality in preterm infants. Cochrane Database Syst Rev. 2005 Jan 25;(1):CD001457. doi: 10.1002/14651858.CD001457.pub2.
PubMed 15674878Coeffier M, Dechelotte P. The role of glutamine in intensive care unit patients: mechanisms of action and clinical outcome. Nutr Rev. 2005 Feb;63(2):65-9. doi: 10.1111/j.1753-4887.2005.tb00123.x.
PubMed 15762090Deutschman CS, Levy RJ, Weiss YG. Glutamine and heat shock proteins: one more approach to lung injury. Crit Care Med. 2005 Jun;33(6):1422-4. doi: 10.1097/01.ccm.0000167072.03551.61. No abstract available.
PubMed 15942367Choudhry MA, Haque F, Khan M, Fazal N, Al-Ghoul W, Ravindranath T, Gamelli RL, Sayeed MM. Enteral nutritional supplementation prevents mesenteric lymph node T-cell suppression in burn injury. Crit Care Med. 2003 Jun;31(6):1764-70. doi: 10.1097/01.CCM.0000063053.31485.DF.
PubMed 12794418Andrews F, Griffiths R. Glutamine-enhanced nutrition in the critically ill patient. Hosp Med. 2002 Mar;63(3):144-7. doi: 10.12968/hosp.2002.63.3.2058.
PubMed 11933816Andrews FJ, Griffiths RD. Glutamine: essential for immune nutrition in the critically ill. Br J Nutr. 2002 Jan;87 Suppl 1:S3-8. doi: 10.1079/bjn2001451.
PubMed 11895153Griffiths RD. Specialized nutrition support in critically ill patients. Curr Opin Crit Care. 2003 Aug;9(4):249-59. doi: 10.1097/00075198-200308000-00001.
PubMed 12883278Griffiths RD. Outcome of critically ill patients after supplementation with glutamine. Nutrition. 1997 Jul-Aug;13(7-8):752-4. doi: 10.1016/s0899-9007(97)83039-0.
PubMed 9263282Griffiths RD, Jones C, Palmer TE. Six-month outcome of critically ill patients given glutamine-supplemented parenteral nutrition. Nutrition. 1997 Apr;13(4):295-302.
PubMed 9178278Yeh CL, Hsu CS, Yeh SL, Lin MT, Chen WJ. Dietary glutamine supplementation reduces cellular adhesion molecule expression and tissue myeloperoxidase activity in mice with gut-derived sepsis. Nutrition. 2006 Apr;22(4):408-13. doi: 10.1016/j.nut.2005.10.007. Epub 2006 Feb 3.
PubMed 16458482
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Systemic Inflammatory Response in Critically Ill Children After Glutamine Supplementation
- ClinicalTrials.gov ID
- NCT01367223
- Acronym / sponsor ID
- UCIHSJD5
- Conditions
- Inflammatory Response, Multi-organ Failure
- Keywords
- inflammatory response, parenteral nutrition, glutamine, amino acid, pediatric, intensive care, systemic infection, abdominal surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Hospital Sant Joan de DeuUniversity, hospital or other
- Collaborators
- Fundació Sant Joan de Déu, Spanish National Health System
- Study start
- Apr 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 7 Jun 2011 (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.
This study aims to describe the use of glutamine supplementation in the modulation of inflammatory response in critically ill pediatric patients and to determine if this decrease leads to clinical improvement in morbidity and mortality in these patients. Thus, these patients' diet could be supplemented with glutamine in order to improve their evolution.
Hypothesis:
From the data obtained in the study of the literature the investigators consider that:
Critically ill patients have a deficit of glutamine either because of an increase in its consumption or a decrease in its availability, and therefore blood glutamine levels are low.
Critically ill patients have elevated blood levels of pro-inflammatory substances (IL-6).
In these patients tissue lesion inhibitors (HSP-70) in the blood are decreased. The administration of glutamine supplements to these patients decreases oxidative stress due to the increase in HSP-70.
Inflammation inhibitory substances (IL-10) in the blood are decreased in these patients.
The administration of glutamine supplements in these patients increase IL-10 levels.
Glutamine supplements decrease the inflammatory response with a decrease in IL-6 levels.
Detailed description
Objective
This study aims to describe the use of glutamine supplementation in the modulation of inflammatory response in critically ill pediatric patients and to determine if this decrease leads to clinical improvement in morbidity and mortality in these patients. Thus, these patients' diet could be supplemented with glutamine in order to improve their evolution.
In recent years numerous studies have been conducted and published on the different factors, amongst them glutamine, that could modulate the inflammatory response of critically ill patients thus reducing the impact this response has and its progression to multi-organ failure.
Glutamine (Gln) is the most abundant amino acid in the body and is mainly synthesised in skeletal muscle. It is a non-essential amino acid that is produced is sufficient quantities in good states of health. Plasma levels are above 0.6 mmol/L, and 50% is found in the free form in plasma1. This amino acid not only acts as a source of energy but it is also involved in the synthesis of other amino acids, nucleotides, nucleic acids, sugars, amines, proteins and different biologically active molecules2. Other functions are: maintenance of the internal acid-base homeostasis, urea synthesis, glyconeogenesis, neurotransmission, and cell differentiation and proliferation. It is also the main energy substrate for the rapidly proliferating cells (enterocytes) and of multiple immune cells (macrophages, monocytes, lymphocytes). It also takes part in the protection of cells and tissues inducing expression of the heat shock proteins3.
In recent years, numerous studies have been performed to determine the effect of Gln, both by enteral and parenteral route, on the evolution of critically ill patients. These studies were conducted in animals and in humans, mainly adults. However, there is little reference in the literature to studies in children. The studies are based on the use of glutamine as a dietary supplement mainly in patients with neoplastic disease or inflammatory bowel disease. It has also been studied as a supplement in premature infants, but there are very few studies in critically ill children.
In the last year many studies have been published on the use of glutamine. The effect of glutamine supplementation on the intestinal mucosal barrier in rabbits under haemorrhagic shock was studied. Shock was induced by blood withdrawing from the femoral artery; the rabbits were randomised to three groups (control, low dose glutamine and high dose glutamine). Plasma levels of diamine oxidase and IL-8 were measured and a histological examination of the terminal ileum was performed. The results demonstrated a lower inflammatory and oxidative response in the rabbits who had received Gln supplementation37. Another study in rats measured the effect of the dipeptide Arginin - Gln on endothelial cell growth factor levels in retinal pigment epithelial cell cultures and on the inhibition of neovascularisation in oxygen-induced retinopathy. The authors concluded that they decreased with the administration of this dipeptide38. Another factor studied in critically ill patients was the oxidative activity measured as diamine oxidase activity and D-lactate content39. Protection against infection and decrease in insulin resistance in critically ill patients is still being studied 21,22, 32, 40, 41. Contradictory findings have been reported therefore new studies are required in systematic reviews.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| solution of amino acids with glutamine | Experimental | Dietary Supplement: solution of amino acids supplemented with glutamineGroup 1 as the experimental group who will be administered a solution of amino acids supplemented with glutamine |
| amino acids solution without glutamine | Other | Dietary Supplement: amino acids not supplemented with glutamineGroup 2:control group will be administered a solution of amino acids (Aminoven Infant® or Vamin®) not supplemented with glutamine |
Who may qualify
- Ages
- 1 month to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 1. Patients aged between 1 month and 14 years who require parenteral nutrition according to the criteria of our unit and who comply with the following diagnoses:
- Local or systemic infection
- Post abdominal surgery
- Polytraumatised
- Intestinal resections
Key exclusion criteria (6 listed)
- Legal representative does not give consent.
- Patients with previous underlying diseases (renal impairment, hepatic impairment, inflammatory bowel disease, rheumatic diseases, metabolic diseases, immunocompromised).
- Mild liver impairment on admittance (hepatitis, colostasis).
- Post cardiac surgery with extracorporeal circulation.
- Patients referred from other hospitals with a clinical evolution of over 48 hours.
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 |
|---|---|---|
| solution of amino acids supplemented with glutamineAlso: (Aminoven Infant® or Vamin®) with glutamine (Dipeptiven®)parenteral nutrition by range of ages (recommendation from ESPGHAN and ESPEN:1 month to 3 years, 3 to 5 years, 6 to 12 and standard adult).Study Parenteral nutrition will be assessed the first 5 days. | Dietary supplement | solution of amino acids with glutamine |
| amino acids not supplemented with glutamineAlso: (Aminoven Infant® or Vamin®) with glutamine (Dipeptiven®)parenteral nutrition by range of ages (recommendation from ESPGHAN and ESPEN:1 month to 3 years, 3 to 5 years, 6 to 12 and standard adult).Study Parenteral nutrition will be assessed the first 5 days. | Dietary supplement | amino acids solution without glutamine |
Primary outcome
The primary study endpoint is to determine if there are any differences in inflammatory response in patients supplemented with glutamine compared to those who receive a standard diet without a glutamine supplement.
Time frame: baseline-day2-day5
Laboratory measures: IL-6, IL-10, HSP-70
1 secondary outcome
As secondary endpoints the clinical response of the two groups of patients was assessed with respect to the occurrence of infections, multi-organ failure, mean stay in the unit and mortality.
Time frame: During 27 days
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 6 Sep 2013.
- Background: PubMed 16276205Bracco D. Glutamine: a double edge sword in the intensive care unit? Crit Care Med. 2005 Nov;33(11):2692-4. doi: 10.1097/01.ccm.0000186750.06199.0f. No abstract available.
- Background: PubMed 16026997Yeh CL, Hsu CS, Yeh SL, Chen WJ. Dietary glutamine supplementation modulates Th1/Th2 cytokine and interleukin-6 expressions in septic mice. Cytokine. 2005 Sep 7;31(5):329-34. doi: 10.1016/j.cyto.2005.06.001.
- Background: PubMed 15891373Wischmeyer PE. Can glutamine turn off the motor that drives systemic inflammation? Crit Care Med. 2005 May;33(5):1175-8. doi: 10.1097/01.ccm.0000162686.28604.81. No abstract available.
- Background: PubMed 14757388Fuentes-Orozco C, Anaya-Prado R, Gonzalez-Ojeda A, Arenas-Marquez H, Cabrera-Pivaral C, Cervantes-Guevara G, Barrera-Zepeda LM. L-alanyl-L-glutamine-supplemented parenteral nutrition improves infectious morbidity in secondary peritonitis. Clin Nutr. 2004 Feb;23(1):13-21. doi: 10.1016/s0261-5614(03)00055-4.
- Background: PubMed 16509783Schulman AS, Willcutts KF, Claridge JA, O'Donnell KB, Radigan AE, Evans HL, McElearney ST, Hedrick TL, Lowson SM, Schirmer BD, Young JS, Sawyer RG. Does enteral glutamine supplementation decrease infectious morbidity? Surg Infect (Larchmt). 2006 Feb;7(1):29-35. doi: 10.1089/sur.2006.7.29.
- Background: PubMed 15674878Tubman TR, Thompson SW, McGuire W. Glutamine supplementation to prevent morbidity and mortality in preterm infants. Cochrane Database Syst Rev. 2005 Jan 25;(1):CD001457. doi: 10.1002/14651858.CD001457.pub2.
- Background: PubMed 15762090Coeffier M, Dechelotte P. The role of glutamine in intensive care unit patients: mechanisms of action and clinical outcome. Nutr Rev. 2005 Feb;63(2):65-9. doi: 10.1111/j.1753-4887.2005.tb00123.x.
- Background: PubMed 15942367Deutschman CS, Levy RJ, Weiss YG. Glutamine and heat shock proteins: one more approach to lung injury. Crit Care Med. 2005 Jun;33(6):1422-4. doi: 10.1097/01.ccm.0000167072.03551.61. No abstract available.
- Background: PubMed 12794418Choudhry MA, Haque F, Khan M, Fazal N, Al-Ghoul W, Ravindranath T, Gamelli RL, Sayeed MM. Enteral nutritional supplementation prevents mesenteric lymph node T-cell suppression in burn injury. Crit Care Med. 2003 Jun;31(6):1764-70. doi: 10.1097/01.CCM.0000063053.31485.DF.
- Background: PubMed 11933816Andrews F, Griffiths R. Glutamine-enhanced nutrition in the critically ill patient. Hosp Med. 2002 Mar;63(3):144-7. doi: 10.12968/hosp.2002.63.3.2058.
- Background: PubMed 11895153Andrews FJ, Griffiths RD. Glutamine: essential for immune nutrition in the critically ill. Br J Nutr. 2002 Jan;87 Suppl 1:S3-8. doi: 10.1079/bjn2001451.
- Background: PubMed 12883278Griffiths RD. Specialized nutrition support in critically ill patients. Curr Opin Crit Care. 2003 Aug;9(4):249-59. doi: 10.1097/00075198-200308000-00001.
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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.
Iolanda Jordan, PhMD principal investigator
Hospital Sant Joan de Deu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing solution of amino acids supplemented with glutamine and amino acids not supplemented with glutamine in people with Inflammatory Response and Multi-organ Failure, run by Hospital Sant Joan de Deu at 1 site in Spain.
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 8 inclusion and 6 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 6 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The primary study endpoint is to determine if there are any differences in inflammatory response in patients supplemented with glutamine compared to those who receive a standard diet without a glutamine supplement. (time frame: baseline-day2-day5). 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 NCT01367223, which also lists 44 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 6 Sep 2013.