Glutamine Supplementation

Mechanical Ventilation Clinical Trial

Official title:

Glutamine Supplementation Guided by Plasma Glutamine Levels

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02738762
• Other study ID #: RTPO 976
• Status: Withdrawn
• Phase: N/A
• First received: April 11, 2016
• Last updated: March 21, 2018
• Start date: November 15, 2017
• Est. completion date: December 2018

Study information

• Verified date: March 2018
• Source: Medical Centre Leeuwarden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glutamine
• Length of Stay
• Mechanical Ventilation

Intervention

Other:
• glutamine supplementation
glutamine supplementation guided by glutamine levels in plasma

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical Centre Leeuwarden

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	amount of enteral glutamine supplementation glutamine level	amount of enteral glutamine supplementation needed to increase the plasma	10 days
Primary	length of mechanical ventilation	difference in length of mechanical ventilation between two groups	10 days
Secondary	hospital mortality	difference in hospital mortality between two groups	6 months