Status:
COMPLETED
Effect of the Amino Acid L-arginine on Perioperative Cardio-vascular Risk in Non-selected Patients
Lead Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Conditions:
Cardiovascular Complication
Eligibility:
All Genders
30-75 years
Phase:
NA
Brief Summary
The aim of the study is to test whether pre-operative oral supplementation with L-arginine results in a significant reduction of peri-operative cardiovascular complication rate in unselected patients ...
Detailed Description
Patients will be recruited for this study from the participating Departments. In a previous study (protocol no. UKE-KP 2002/006) we investigated the predictive role of ADMA (asymmetric dimethylarginin...
Eligibility Criteria
Inclusion
- 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
- 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 patient'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 upper limit of the normal range);
- severe renal failure (calculated creatinine clearance \< 30 ml/min \[Cockcroft-Gault formula\]), nephrotic syndrome or dysproteinemia;
- previous intolerance of L-arginine or L-citrulline.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
269 Patients enrolled
Trial Details
Trial ID
NCT01413815
Start Date
October 1 2010
End Date
September 1 2012
Last Update
July 1 2022
Active Locations (5)
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1
Klinik für Anästhesiologie,Städtisches Klinikum Lüneburg
Lüneburg, Lower Saxony, Germany, 21339
2
Institut für Experimentelle und Klinische Pharmakologie,Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
3
Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie,Kath. Marienkrankenhaus gGmbH
Hamburg, Germany, 20246
4
Klinik und Poliklinik für Anästhesiologie, Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246