Glutamine Supplementation

Not Applicable

Withdrawn

• Conditions: Length of Stay; Glutamine; Mechanical Ventilation

• Registration Number: NCT02738762
• Lead Sponsor: Medical Centre Leeuwarden

Brief Summary

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.

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 Timeline

• Study First Submitted: 2016-04-11
• Study First Submitted QC: 2016-04-11
• Study First Posted: 2016-04-14
• Study Start: 2017-11-15
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-21
• Last Update Posted: 2018-03-23
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
amount of enteral glutamine supplementation glutamine level	10 days	amount of enteral glutamine supplementation needed to increase the plasma
length of mechanical ventilation	10 days	difference in length of mechanical ventilation between two groups

Secondary Outcome Measures

Name	Time	Method
hospital mortality	6 months	difference in hospital mortality between two groups