Glutamine Supplementation in Critically Ill Patients With Severe Sepsis

NCT03048994 | Completed DMC

• 1 other identifier: CTC1000338
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Severe Sepsis

Keywords

Glutamine; Severe sepsis

Outcome Measures

Primary Outcomes (1)

• Mortality

  28 day

Secondary Outcomes (4)

• Occurrence of new infections

  Initial hospital admission, assessed up to 130 days.

• ICU length of stay (LOS)

  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

  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

  During period of ICU stay, assessed up to 14 days.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Glutamine

ACTIVE COMPARATOR

Glutamine

Dietary Supplement: Glutamine

Interventions

Glutamine DIETARY_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.

Glutamine

Placebo DIETARY_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.

Placebo

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• \>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)
• 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

Sponsors & Collaborators

• Changi General Hospital: lead
• Singhealth Foundation: collaborator

Study Sites (1)

Changi General Hospital

Singapore, Singapore

Location

Related Publications (3)

• 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.

  PMID: 12352035 BACKGROUND

• Roth 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.

  PMID: 16829366 BACKGROUND

• Heyland 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.

  PMID: 15605227 BACKGROUND

MeSH Terms

Conditions

Sepsis

Interventions

Glutamine

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Neutral

Study Officials

• Vijo Poulose

  Changi General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2012
• First Posted: February 9, 2017
• Study Start: January 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: February 9, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)