Effect of oral supplementation with the amino acid L-arginine on peri- operative cardiovascular risk in non-selected patients – Role of pre-operative determination of plasma ADMA levels for therapeutic stratification.

Not Applicable

• Conditions: 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.

• Registration Number: DRKS00016797
• Lead Sponsor: niversitätsklinikum Hamburg-Eppendorf

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2012-05-28
• Study Start: 2019-03-05
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 269

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

• 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.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
- 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;<br>- 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;<br>- the difference in incidence of the combined primary endpoint between patients on beta-blocker treatment or not on beta-blocker treatment, respectively;<br>- the difference in incidence of the combined primary endpoint between patients on statin treatment or not on statin treatment, respectively;<br>- the difference in incidence of the combined primary endpoint between L-arginine and placebo for each of the ASA classes II to IV, respectively;<br>- the difference in incidence of each of the components of the combined endpoint separately;<br>- the change in plasma L-arginine / ADMA ratio.