Vascular allograft nephropathy represents the main cause of renal allograft loss after 1 yr of transplantation. The trial shall find a way for early diagnostics.
Conditions
Interventions
Trade Name: SonoVue 8 Mikroliter/ml Pulver und Lösungsmittel
zur Herstellung einer Dispersion
zur Injektion
Pharmaceutical Form:
INN or Proposed INN: SonoVue 8 Mikroliter/ml Pulver und Lösungsmittel
Sponsors
University of Heidelberg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who have had stable renal allograft function for at least three months. Patients with a written informed consent. Patients over 18 years. Patients of the Department of Nephrology; University Heidelberg (D). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes 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
Exclusion criteria
Exclusion criteria: Allograft recipients with lymphocele (>100ml), Patients with significant renal transplant artery stenosis (>70%) Patients with hydronephrosis of grade 2 (dilatation of the renal pelvis and the calyces, with or without a dilatation of the proximal ureter) or more. Patients with a familiar incompatibility against SonoVue TM Patients with pregnancy. Patients are allergic to proteins. Patients with pulmonary hypertension. Patients wirh a thrombotic diathesm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Real-time contrast enhanced sonography can assess microvascular tissue perfusion using gas-filled microbubbles. The study shall evaluate the feasibility of RT-CES in detecting vascular allograft nephropathy in comparison to colour Doppler ultrasonography.;Secondary Objective: ;Primary end point(s): to evaluate the feasibility of RT-CES in detecting vascular allograft nephropathy in comparison to colour Doppler ultrasonography | — |
Countries
Germany
Outcome results
None listed