Glutamine Supplementation

NCT02738762 | Withdrawn

• 1 other identifier: RTPO 976
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Glutamine; Length of Stay; Mechanical Ventilation

Keywords

intensive care; glutamine; length of stay

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• hospital mortality

  6 months

Study Arms (2)

intervention group

ACTIVE COMPARATOR

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

control group

NO INTERVENTION

patients receive normal treatment, no glutamine supplementation

Interventions

glutamine supplementation OTHER

glutamine supplementation guided by glutamine levels in plasma

intervention group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Frisius Medisch Centrum: lead

Study Officials

• Matty Koopmans, MSc

  MCL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc

Study Record Dates

• First Submitted: April 11, 2016
• First Posted: April 14, 2016
• Study Start: November 15, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 23, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share