Observational Study on Plasma Glutamine Levels Before and After Cardiac Surgery

Earlier studies showed that a low glutamine level at acute admission on the ICU is associated with a poor outcome [3,4]. Recently, we found that a low plasma glutamine is correlated with severity of illness and presence of an infection after non-elective ICU admission [5, submitted].

Study Overview

• Status: Completed
• Conditions: Glutamin Level
• Intervention / Treatment: Procedure: no intervention, blood is sampled for routine

Detailed Description

It is known that major surgery induces a stress response characterised by hormonal release and inflammatory processes [6,7]. This surgical stress response resembles the catabolic stress which is found in other forms of critical illness. We did not measure plasma glutamine before surgery so it is unknown whether the plasma glutamine level was already low before surgery in these patients or that the lowering of plasma glutamine level is a consequence of surgery. Most of the patients in the elective surgery group in our study underwent cardiac surgery with use of cardiopulmonary bypass; it is known that extracorporeal circulation induces an inflammatory response but there are no clinical data on the effects on plasma glutamine or on post-operative course in relation to plasma glutamine levels [8,9].

• Study Type: Observational
• Enrollment (Actual): 90

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All consecutive patients who undergo elective cardio-thoracic surgery during a 6 to 8 week period.

We aim to include at least 90 patients.

Description

Inclusion Criteria:

• patients undergoing elective cardiac surgery

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
elective cardiac surgery patients; consecutive patients who undergo elective cardio-thoracic surgery during a 6 to 8 week period	Procedure: no intervention, blood is sampled for routine; no intervention, blood sampled for standard evaluation will be used for determination of plasma glutamin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
plasma glutamine	intraoperative

Collaborators and Investigators

• Sponsor: Medical Centre Leeuwarden
• Investigators: Principal Investigator: Hanneke Buter, MD, MCL

Publications and helpful links

General Publications

• Buter H, Koopmans M, Kemperman R, Jekel L, Boerma C. Plasma glutamine levels before cardiac surgery are related to post-surgery infections; an observational study. J Cardiothorac Surg. 2016 Nov 25;11(1):155. doi: 10.1186/s13019-016-0549-1.

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: May 12, 2015
• First Submitted That Met QC Criteria: May 13, 2015
• First Posted (Estimate): May 14, 2015

Study Record Updates

• Last Update Posted (Estimate): February 17, 2016
• Last Update Submitted That Met QC Criteria: February 16, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: nWMO 115