Observational Study on the Course of Plasma Glutamine Levels During Critical Illness

Glutamine Levels Clinical Trial

Official title:

Observational Study on the Course of Plasma Glutamine Levels During Critial Illness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02310035
• Other study ID #: nWMO48
• Status: Completed
• Phase: N/A
• First received: December 1, 2014
• Last updated: May 12, 2015
• Start date: April 2014
• Est. completion date: September 2014

Study information

• Verified date: May 2015
• Source: Medical Centre Leeuwarden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial Summary

Blood sampled for standard evaluation will be used for determination of plasma glutamine by Bioprofile Flex Glutamine Sensor at ICU admission

Description:

All patients who are admitted to the ICU after elective surgery and non-elective admissions. In both groups a total of 80 patients will be included.

(In the trials we mentioned in the introduction 80, 174 and 66 patients were included. In the study performed by Oudemans-van Straaten a decent distribution between lower and higher levels of glutamine was achieved in 80 non-elective patients.) Exclusion criteria are patients younger then 18 years and patients who need total parenteral nutrition (TPN).

The patients will receive standard care during their treatment on the ICU. Blood sampled for standard evaluation will be used for determination of plasma glutamine by Bioprofile Flex Glutamine Sensor at ICU admission. Hereafter plasma glutamine will be measured daily, a plasma sample will be taken from a standard evaluation blood sample at 6.00 am during admission on the ICU.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• all patients admitted to the ICU

Exclusion Criteria:

• younger then 18 years and patients who need total parenteral nutrition

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glutamine Levels

Locations

Country	Name	City	State
Netherlands	Medical Centre Leeuwarden	Leeuwarden

Sponsors (1)

Lead Sponsor	Collaborator
Medical Centre Leeuwarden

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glutamine in serum	glutamine level at admission and during ICU stay daily	from admission up to 8 days	No