Status:
COMPLETED
CE-US in Renal Transplantation
Lead Sponsor:
Mario Negri Institute for Pharmacological Research
Conditions:
Renal Transplantation
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Acute allograft dysfunction is often observed in the first weeks after kidney transplantation. Renal biopsy is universally considered the gold standard procedure for differential diagnosis of acute al...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Age \> 18 years
- Kidney transplantation with a functioning graft (dialysis independence)
- Clinical indication to histologic evaluation of the kidney graft
- Written Informed consent (according to the Declaration of Helsinki guidelines)
- Exclusion criteria:
- Specific contraindications to histologic evaluation of the kidney graft (bleeding time \> 15 min, intra-abdominal implantation of the graft)
- Known hypersensitivity to sulphur hexafluoride or to any of the components of SonoVue.
- Recent Acute Coronary Syndrome (ACS) or clinically unstable ischaemic cardiac disease, including: evolving or ongoing myocardial infarction, typical angina at rest within last 7 days, significant worsening of cardiac symptoms within last 7 days, recent coronar artery intervention or other factors suggesting clinical instability (for example, recent deterioration of ECG, laboratory or clinical findings), acute cardiac failure, Class III/IV cardiac failure, or severe rhythm disorders.
- Right-to-left shunts, severe pulmonary hypertension (PAP \>90 mmHg
Exclusion
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01815320
Start Date
April 1 2011
End Date
September 1 2013
Last Update
October 29 2013
Active Locations (1)
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1
Unità di Nefrologia e Dialisi - A.O. Papa Giovanni XXIII
Bergamo, Bergamo, Italy