Inclusion criteria require patients to be subject to major abdominal or thoracic (non-cardiovascular) surgery, incl. intestinal resection, prostate surgery, renal surgery, spine surgery and other entities.
Conditions
Interventions
Group 1: L-arginine/L-citrulline supplement
Group 2: Placebo
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Eligibility
Sex/Gender
All
Age
30 Years to 75 Years
Inclusion criteria
Inclusion criteria: • male and female subjects aged between 30 and 75 years; • scheduled major thoracic (non-cardiac), abdominal, or two cavity surgery; • ASA risk class II- IV; • efficient birth control for women in child-bearing age; • signed written informed consent form.
Exclusion criteria
Exclusion criteria: • participation in a clinical study within the last 3 months before inclusion into the present study; • high allergic tendency in the medical history at the investigators discretion; • patients with known diabetic retinopathy; • previous abuse of drugs or alcohol; • pregnancy or nursing; • any severe consuming disease (malignant or non-malignant) that reduces the pa-tient’s life expectancy to a level which makes it uncertain that the patient would survive the 30 day period even without surgery; • any somatic or psychic disease that may hamper participation in the study or compliance; • active liver disease or hepatic failure (serum AST or ALT >1.5-fold above the up-per limit of the normal range); • severe renal failure (calculated creatinine clearance < 30 ml/min [Cockroft-Gault formula]), nephrotic syndrome or dysproteinemia; • previous intolerance of L-arginine or L-citrulline.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the difference in incidence of the combined end-point of death of any cause, acute myocardial infarction or acute coronary syndrome, decompensated heart failure, cardiac arrest or re-suscitation, severe arrhythmia, and cerebral or pulmonary embolism between L-arginine and placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| - the difference in incidence of the combined primary endpoint between L-arginine and placebo for the subgroups with ADMA below and above the median concentration, respectively; - the difference in incidence of the combined primary endpoint between L-arginine and placebo for the subgroups with ADMA in each of the quartiles and tertiles of ADMA levels, respectively; - the difference in incidence of the combined primary endpoint between patients on beta-blocker treatment or not on beta-blocker treatment, respectively; - the difference in incidence of the combined primary endpoint between patients on statin treatment or not on statin treatment, respectively; - the difference in incidence of the combined primary endpoint between L-arginine and placebo for each of the ASA classes II to IV, respectively; - the difference in incidence of each of the components of the combined endpoint separately; - the change in plasma L-arginine / ADMA ratio. | — |
Countries
Germany
Contacts
Public ContactRainer Böger
Universitätsklinikum Hamburg-EppendorfInstitut für Klinische Pharmakologie und Toxikologie
Outcome results
None listed