Arginine and nitric oxide (NO) metabolism in sepsis: L-Citrulline enteral supplementation for the normalisation of the Arginine-NO metabolism.

Recruiting

Conditions: Alle vormen van sepsis of septische shock
blood born infection
sepsis
10002252

Registration Number: NL-OMON37149

Lead Sponsor: Algemene Heelkunde

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 48

Inclusion Criteria

1. Written informed consent from close relative
2. Age > 18 years
3. patient meets the general criteria for severe sepsis or septic shock, diagnosed less than 48 h prior to study inclusion. (according to Levy and Fink et al. Intensive care med 29: 530-538. 2003)
4. Patient must be relatively hemodynamically stable, defined as stable blood pressure (variation in mean arterial pressure < 15 mm Hg), during 2 h without necessity of increasing the vasopressor dose, inotropic support or rate of fluid administration.
5. Systemic arterial catheter in place with continous pressure monitoring.
6. Patients in whom the clinician is prepared to provide full life support during duration of the study.

Exclusion Criteria

1. Shock due to any cause other than sepsis (e.g drug reaction or drug overdose, pulmonary embolus, burn injury etc.)
2. prolonged or high dose corticosteroid use
3. chronic pancreatitis
5. insulin-dependent diabetes mellitus
6. metastases, haematological malignancies or chemotherapy
7. patients on dialysis (CVVH or other)
8. pre-existent renal failure (on dialysis)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary study endpoints are the imporvement of the citrulline plasma<br /><br>concentrations and the arginine-NO metabolism, which will be determined in<br /><br>blood samples. To determine the NO production we will measure the Nitrosyl-Hb<br /><br>in whole blood. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secundary study parameters are the microcirculation, using gastric tonometry,<br /><br>which measures the pCO2 of the stomach, and the microcirculation. Sidestream<br /><br>Darkfiled Imaging (SDF) is used to investigate the microvasculature directly<br /><br>sublingual, as an indication for organ vascularisation. Organ function scores<br /><br>will also be evaluated. </p><br>