Glutamine Supplementation

Glutamine Supplementation Guided by Plasma Glutamine Levels

Earlier studies showed a benefit in survival when glutamine was given intravenously and these studies lead to recommendations that glutamine should be given to critically ill patients. The ESPEN guidelines recommend 0,2-0,4 g/kg/d intravenous glutamine added to standard parenteral nutrition .

Until recently it was not possible to obtain a plasma glutamine level fast enough to consider the result for clinical decision making. With the availability of a Point of Care (POCT) measurement of plasma glutamine level a measurement can be performed short after the collection of blood. This offers the possibility to identify a patient with a low plasma glutamine level shortly after admission and use repeated measurements for evaluation of the response to supplementation of glutamine.

Study Overview

• Status: Withdrawn
• Conditions: Mechanical Ventilation; Length of Stay; Glutamine
• Intervention / Treatment: Other: glutamine supplementation

Detailed Description

• At admission (day 0) a plasma glutamine level is measured. The measurement can be performed from blood taken for the first arterial blood gas analysis. Patients are eligible for the study when the plasma glutamine level is lower than 420 µmol/l.
• After informed consent is obtained patients are randomised to receive enteral glutamine or not ( the control group). Enteral glutamine supplementation is started (day 1) at a dose of 3 sachets per day given at 6.00, 14.00 and 22.00 hr. A sachet contains 9 grams of L-glutamine ( Glutaperos®, GLNP Life Sciences).
• Enteral glutamine supplementation will be given for a maximum of 10 days or until the patient is discharged from the ICU.
• Plasma glutamine levels will be measured four times a day, at 06.00, 12.00, 18.00 and 00.00 hours, concurrently with the standard arterial blood gas analyses so no extra blood is taken from the patient.
• On day 3 at 12.00 hours the dose of glutamine will be increased to 3 times 2 sachets if plasma glutamine level is still below 420 µmol/l.
• From day 3 ( 12.00 hrs) until day 10 ( end of study) the dosage of enteral glutamine will be evaluated daily at 12.00 hours. When the plasma glutamine level is higher than 420 µmol/l the dosage of enteral glutamine will be adjusted according to the schedule below.
• In patients who randomized to the control group, the plasma glutamine level will be measured daily at 12.00 hr concurrently with standard arterial blood gas analysis

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• all patients admitted to the ICU with an expected stay of 48 hours or longer
• glutamine level lower thand 420 mmol/l

Exclusion Criteria:

• age under 18 years
• readmission to the ICU
• contra indication for enteral nutrition
• use of total parental nutrition

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: intervention group; enteral glutamine supplementation guided by glutamine level Enteral glutamine supplementation is started (day 1) at a dose of 3 sachets per day given at 6.00, 14.00 and 22.00 hr. A sachet contains 9 grams of L-glutamine ( Glutaperos®, GLNP Life Sciences). Enteral glutamine supplementation will be given for a maximum of 10 days or until the patient is discharged from the ICU	Other: glutamine supplementation; glutamine supplementation guided by glutamine levels in plasma
No Intervention: control group; patients receive normal treatment, no glutamine supplementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
amount of enteral glutamine supplementation glutamine level	amount of enteral glutamine supplementation needed to increase the plasma	10 days
length of mechanical ventilation	difference in length of mechanical ventilation between two groups	10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hospital mortality	difference in hospital mortality between two groups	6 months

Collaborators and Investigators

• Sponsor: Medical Centre Leeuwarden
• Investigators: Principal Investigator: Matty Koopmans, MSc, MCL

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2017
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: April 11, 2016
• First Submitted That Met QC Criteria: April 11, 2016
• First Posted (Estimate): April 14, 2016

Study Record Updates

• Last Update Posted (Actual): March 23, 2018
• Last Update Submitted That Met QC Criteria: March 21, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: intensive care; glutamine; length of stay
• Other Study ID Numbers: RTPO 976

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: patient data is anonym

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No