Severe SepsisCGH-GLUNCT03048994
Glutamine Supplementation in Critically Ill Patients With Severe Sepsis
A study testing Glutamine in people with Severe Sepsis, run by Changi General Hospital at 1 site in Singapore.
Trial summary
Severe sepsis is a common condition with high mortality and morbidity. A previous meta-analysis has demonstrated the safety of glutamine supplementation with suggestion of mortality and morbidity benefits in critically ill patients. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Severe Sepsis
- What is being tested?
- Glutamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteSingapore
- Study dates
- Jan 2011to Jun 2013
- Phase
- Interventional
- 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 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients (>18 years old) admitted to ICU plus
- Severe sepsis defined as 2 or more or the following
- Temperature >38oC or < 36oC
- Heart rate > 90 beats per min
- Respiratory rate >20 breaths per min or PaCO2 <32 mmHg
- White cell count > 12,000/microL or < 4,000/microL
Show all 15Show fewer
- PLUS presence or presumed presence of infection
- PLUS evidence of organ dysfunction as defined by either of the following
- Hemodynamic: Hypotension = systolic blood pressure (SBP) 40 mm Hg or mean arterial pressure (MAP) < 65 mm Hg; or on vasopressors
- Hyperlactatemia: Serum lactate >/= 2 mmol/L (18 mg/dL)
- Renal: Acute increase in serum creatinine to > 176.8 mmol/L (2.0 mg/dL) or urine output < 0.5 mL/kg/hour for > 2 hours
- Lung: Acute lung injury with PaO2/FiO2 </=300mmHg
- Liver: Acute increase in bilirubin to >/= 34.2 umol/L (2 mg/dL)
- Thrombocytopenia: Acute decrease in platelet count to < 100,000 cells/mm3
- Coagulopathy: International normalized ratio (INR) > 1.5 or a partial thromboplastin time (aPTT) > 60 secs which is not due to anticoagulant therapy
Who cannot join
- >48hr from admission to ICU
- Patients who are not expected to survive >48hrs by the managing team
- Refusal to consent to study
- Allergic to glutamine or its constituents
- Absolute contraindication to enteral nutrition or the need to initiate parenteral nutrition
- Patients with a primary admission diagnosis of burns (>30% body surface area)
Show all 10Show fewer
- Patients whose weight <40kg or >200kg
- Previous randomization to this study
- Enrolled in a related ICU interventional nutrition study
- Pregnant patients or lactating mothers with the intent to breastfeed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Glutamine Supplementation in Critically Ill Adults With Severe Sepsis: A Pilot Study
Severe sepsis is a common condition with high mortality and morbidity. A previous meta-analysis has demonstrated the safety of glutamine supplementation with suggestion of mortality and morbidity benefits in critically ill patients. But there is lack of evidence to recommend the use of intravenous glutamine supplementation in this population group. A randomized controlled trial which is adequately powered will resolve this issue and can be included in future international nutrition guidelines for the critically ill. This pilot study is done prior to a proposed local multi-center study to investigate the effects of glutamine supplementation.
Read the detailed description
Objective
- To determine the effect of intravenous glutamine supplementation compared with placebo in critically ill patients with severe sepsis
- Primary outcome : 28 day mortality , Development of infectious complications
- Secondary outcomes
- Duration of mechanical ventilation
- Length of stay in ICU
- Length of stay in hospital
- 3 month survival status and resumption of baseline activities
- 6 month survival status and resumption of baseline activities
Study Design
- Single center, prospective, double blind, randomised controlled trial critically ill patients with severe sepsis
- Randomisation
- A centralised randomisation system at SCRI (Singapore Clinical Research institute)
- Allocation will be random and concealed, and will be blinded to everyone except the pharmacist at each site, who will be responsible for preparing and delivering them to the ICU in a blinded fashion.
- Intervention
- Patients randomised to receive glutamine supplementation will receive IV glutamine (0.5g/kg body weight/day) continuously over 24 hours.
- IV glutamine will be administered for 5 days or less if death ensues prior to 5 days or transferred to another hospital prior to 5 days. IV glutamine will be continued even if the patient is transferred outside the ICU but within the hospital.
- An intravenous saline solution that is identical in volume, color and consistency will be administered to the placebo group with the same dosing regimen and duration.
- Cointerventions
- Nutritional support will be continued as per managing ICU team discretion.
- Management of severe sepsis will be continued as per managing ICU team discretion.
- Weaning patients from mechanical ventilation will be done as per managing ICU team discretion.
- To minimise differences between centers, active dissemination of practice guidelines for nutritional support, sepsis management and weaning will be carried out.
Execution of study protocol
- The managing ICU team will be responsible in identifying patients that meet the inclusion and exclusion criteria and will inform the site research coordination
- The site research coordinator will be responsible for the following
- Obtaining consent from relatives of the patients
- Informing the site pharmacist about the recruited patients
- Follow study patients prospectively while in the ICU, hospital and post discharge at 3 and 6 months.
- Completing the case report from for each study participant
- Submitting case report forms, completed and interim reports, to coordinating statistical team
- Pharmacist
- Site pharmacist to liase with SCRI on randomised patients status (treatment vs. placebo)
- Prepare the intervention treatment and placebo
- Deliver the treatment and placebo to the respective patients.
- Nurses
- Responsible for administering the delivered medications
- Ensure and documenting compliance with administration, reasons for interruptions and documenting adverse reactions.
- Liasing with the site research coordinator daily regarding the above.
- Liasing with the site research coordinator on transfer, discharge or death of study participants
- Conditions
- Severe Sepsis
- Being tested
- Glutamine, Placebo
- Keywords
- Glutamine, Severe sepsis
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlutamineDietary supplement
- Patients randomised to receive glutamine supplementation will receive IV glutamine (0.5g/kg body weight/day) continuously over 24 hours.
- IV glutamine will be administered for 5 days or less if death ensues prior to 5 days or transferred to another hospital prior to 5 days. IV glutamine will be continued even if the patient is transferred outside the ICU but within the hospital.
- An intravenous saline solution that is identical in volume, color and consistency will be administered to the placebo group with the same dosing regimen and duration.
PlaceboDietary supplement
- Nutritional support will be continued as per managing ICU team discretion.
- Management of severe sepsis will be continued as per managing ICU team discretion.
- Weaning patients from mechanical ventilation will be done as per managing ICU team discretion.
- To minimise differences between centers, active dissemination of practice guidelines for nutritional support, sepsis management and weaning will be carried out.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
| Glutamine | Active comparator | Glutamine Receives: Dietary Supplement: Glutamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: 28 day
Secondary outcomes (4)
Occurrence of new infections
Measured: Initial hospital admission, assessed up to 130 days.
ICU length of stay (LOS)
Measured: From date of ICU admission to date of transferred to General Ward or date of death from any cause, whichever came first, assessed up to 21 days.
Hospital LOS
Measured: From date of recruitment to date of discharged from hospital or date of transferred to other hospitals or date of death from any cause, whichever came first, assessed up to 130 days.
Duration of mechanical ventilation
Measured: During period of ICU stay, assessed up to 14 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study startJan 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Severe SepsisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Singhealth Foundation
- Responsible party
- Sponsor
- Investigators
- Vijo Poulose, Principal investigator, Changi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03048994
- Sponsor's protocol ID
- CTC1000338
- Acronym
- CGH-GLU
- Status last verified
- Feb 2017
- First submitted
- 24 Sep 2012
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Novak F, Heyland DK, Avenell A, Drover JW, Su X. Glutamine supplementation in serious illness: a systematic review of the evidence. Crit Care Med. 2002 Sep;30(9):2022-9. doi: 10.1097/00003246-200209000-00011.
PubMed 12352035Roth E, Funovics J, Muhlbacher F, Schemper M, Mauritz W, Sporn P, Fritsch A. Metabolic disorders in severe abdominal sepsis: glutamine deficiency in skeletal muscle. Clin Nutr. 1982 Mar;1(1):25-41. doi: 10.1016/0261-5614(82)90004-8.
PubMed 16829366Heyland DK, Dhaliwal R, Suchner U, Berger MM. Antioxidant nutrients: a systematic review of trace elements and vitamins in the critically ill patient. Intensive Care Med. 2005 Mar;31(3):327-37. doi: 10.1007/s00134-004-2522-z. Epub 2004 Dec 17.
PubMed 15605227
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Glutamine Supplementation in Critically Ill Adults With Severe Sepsis: A Pilot Study
- ClinicalTrials.gov ID
- NCT03048994
- Acronym / sponsor ID
- CGH-GLU / CTC1000338
- Conditions
- Severe Sepsis
- Keywords
- Glutamine, Severe sepsis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Collaborators
- Singhealth Foundation
- Study start
- Jan 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 9 Feb 2017 (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.
Severe sepsis is a common condition with high mortality and morbidity. A previous meta-analysis has demonstrated the safety of glutamine supplementation with suggestion of mortality and morbidity benefits in critically ill patients. But there is lack of evidence to recommend the use of intravenous glutamine supplementation in this population group. A randomized controlled trial which is adequately powered will resolve this issue and can be included in future international nutrition guidelines for the critically ill. This pilot study is done prior to a proposed local multi-center study to investigate the effects of glutamine supplementation.
Detailed description
Objective
- To determine the effect of intravenous glutamine supplementation compared with placebo in critically ill patients with severe sepsis
- Primary outcome : 28 day mortality , Development of infectious complications
- Secondary outcomes
- Duration of mechanical ventilation
- Length of stay in ICU
- Length of stay in hospital
- 3 month survival status and resumption of baseline activities
- 6 month survival status and resumption of baseline activities
Study Design
- Single center, prospective, double blind, randomised controlled trial critically ill patients with severe sepsis
- Randomisation
- A centralised randomisation system at SCRI (Singapore Clinical Research institute)
- Allocation will be random and concealed, and will be blinded to everyone except the pharmacist at each site, who will be responsible for preparing and delivering them to the ICU in a blinded fashion.
- Intervention
- Patients randomised to receive glutamine supplementation will receive IV glutamine (0.5g/kg body weight/day) continuously over 24 hours.
- IV glutamine will be administered for 5 days or less if death ensues prior to 5 days or transferred to another hospital prior to 5 days. IV glutamine will be continued even if the patient is transferred outside the ICU but within the hospital.
- An intravenous saline solution that is identical in volume, color and consistency will be administered to the placebo group with the same dosing regimen and duration.
- Cointerventions
- Nutritional support will be continued as per managing ICU team discretion.
- Management of severe sepsis will be continued as per managing ICU team discretion.
- Weaning patients from mechanical ventilation will be done as per managing ICU team discretion.
- To minimise differences between centers, active dissemination of practice guidelines for nutritional support, sepsis management and weaning will be carried out.
Execution of study protocol
- The managing ICU team will be responsible in identifying patients that meet the inclusion and exclusion criteria and will inform the site research coordination
- The site research coordinator will be responsible for the following
- Obtaining consent from relatives of the patients
- Informing the site pharmacist about the recruited patients
- Follow study patients prospectively while in the ICU, hospital and post discharge at 3 and 6 months.
- Completing the case report from for each study participant
- Submitting case report forms, completed and interim reports, to coordinating statistical team
- Pharmacist
- Site pharmacist to liase with SCRI on randomised patients status (treatment vs. placebo)
- Prepare the intervention treatment and placebo
- Deliver the treatment and placebo to the respective patients.
- Nurses
- Responsible for administering the delivered medications
- Ensure and documenting compliance with administration, reasons for interruptions and documenting adverse reactions.
- Liasing with the site research coordinator daily regarding the above.
- Liasing with the site research coordinator on transfer, discharge or death of study participants
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 |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
| Glutamine | Active comparator | Dietary Supplement: GlutamineGlutamine |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- All adult patients (>18 years old) admitted to ICU plus
- Severe sepsis defined as 2 or more or the following
Key exclusion criteria (10 listed)
- >48hr from admission to ICU
- Patients who are not expected to survive >48hrs by the managing team
- Refusal to consent to study
- Allergic to glutamine or its constituents
- Absolute contraindication to enteral nutrition or the need to initiate parenteral nutrition
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 |
|---|---|---|
| Glutamine* Patients randomised to receive glutamine supplementation will receive IV glutamine (0.5g/kg body weight/day) continuously over 24 hours. * IV glutamine will be administered for 5 days or less if death ensues prior to 5 days or transferred to another hospital prior to 5 days. IV glutamine will be continued even if the patient is transferred outside the ICU but within the hospital. * An intravenous saline solution that is identical in volume, color and consistency will be administered to the placebo group with the same dosing regimen and duration. | Dietary supplement | Glutamine |
| Placebo* Nutritional support will be continued as per managing ICU team discretion. * Management of severe sepsis will be continued as per managing ICU team discretion. * Weaning patients from mechanical ventilation will be done as per managing ICU team discretion. * To minimise differences between centers, active dissemination of practice guidelines for nutritional support, sepsis management and weaning will be carried out. | Dietary supplement | Placebo |
Primary outcome
Mortality
Time frame: 28 day
4 secondary outcomes
Occurrence of new infections
Time frame: Initial hospital admission, assessed up to 130 days.
ICU length of stay (LOS)
Time frame: From date of ICU admission to date of transferred to General Ward or date of death from any cause, whichever came first, assessed up to 21 days.
Hospital LOS
Time frame: From date of recruitment to date of discharged from hospital or date of transferred to other hospitals or date of death from any cause, whichever came first, assessed up to 130 days.
Duration of mechanical ventilation
Time frame: During period of ICU stay, assessed up to 14 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 9 Feb 2017.
- Background: PubMed 12352035Novak F, Heyland DK, Avenell A, Drover JW, Su X. Glutamine supplementation in serious illness: a systematic review of the evidence. Crit Care Med. 2002 Sep;30(9):2022-9. doi: 10.1097/00003246-200209000-00011.
- Background: PubMed 16829366Roth E, Funovics J, Muhlbacher F, Schemper M, Mauritz W, Sporn P, Fritsch A. Metabolic disorders in severe abdominal sepsis: glutamine deficiency in skeletal muscle. Clin Nutr. 1982 Mar;1(1):25-41. doi: 10.1016/0261-5614(82)90004-8.
- Background: PubMed 15605227Heyland DK, Dhaliwal R, Suchner U, Berger MM. Antioxidant nutrients: a systematic review of trace elements and vitamins in the critically ill patient. Intensive Care Med. 2005 Mar;31(3):327-37. doi: 10.1007/s00134-004-2522-z. Epub 2004 Dec 17.
- Individual participant dataSharing planned: No
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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.
Vijo Poulose principal investigator
Changi General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glutamine in people with Severe Sepsis, run by Changi General Hospital at 1 site in Singapore.
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 15 inclusion and 10 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 9 Feb 2017. 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 Singapore. 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. Some participants in this study may receive a placebo. 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?
Mortality (time frame: 28 day). 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 NCT03048994, which also lists 3 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 9 Feb 2017.