Systemic hypotension following intravenous administration of contrast medium during computed tomography.

Conditions: Primary goal of this study is to quantify changes in systolic and diastolic blood pressure, heart rate and pO2 before and after i.v. administration of either IOCM or LOCM. In particular the occurrence of clinically relevant drops in systolic and diastolic blood pressure after IOCM or LOCM administration is investigated.
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Registration Number: EUCTR2013-002051-15-AT

Lead Sponsor: Innsbruck Medical University, Department of Radiology, Section of Microinvasive Therapy

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

•Primary or secondary liver tumors treatable by SRFA.
•Approval of an interdisciplinary cancer board for SRFA.
•Adult patients > 18 years, American Society of Anesthesiologists (ASA) score I-III, scheduled for radiological interventions with CM (obligate application) under general anesthesia.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

•Reduced mental status of the patient, history of psychiatric disorder, refusal by patient, failure to obtain written and informed consent.
•Primary or secondary liver tumors larger than 12 cm in diameter or prediction of insufficient liver remnant, more than 7 lesions, lesions within 1 cm distance to the central bile duct, lesions infiltrating adjacent hollow viscera.
•Liver cirrhosis classified higher than Child-Pugh class B, manifest ascites.
•Estimated glomerular filtration rate (eGFR) <45.
•Clotting disorders (PT < 50%, apTT >50 sec and thrombocytes < 50,000/mm3) or recent intake of platelet aggregation inhibitors
•Evidence of intolerance or allergic reactions against both CM.
•Contraindications to both CM according to Austrian Fachinformation
•Antihypertensive treatment except Midazolam (Dormicum®, Roche Pharmaceutics, Vienna, Austria) orally 30 minutes prior to surgery at dose between 3.75 and 7.5 mg.