Status:
COMPLETED
Kidney Disease and Ultrasound Imaging
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Fondation de l'Avenir
Bracco Imaging S.p.A.
Conditions:
Recipient of Kidney Transplant
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The hypothesis of our study is that a correlation exists between the couple ultrasound elastography- renal perfusion estimated with contrast-enhanced ultrasound and the degree of fibrosis estimated in...
Detailed Description
Kidney transplant patients are exposed to long-term immunosuppressive therapy, and have an increased risk of infections and cancer, while a lack of treatment increases the risk of rejection. The devel...
Eligibility Criteria
Inclusion
- Age ≥ 18 years;
- Patient with informed consent;
- Recipient of a living donor graft or cadaveric donor patient;
- No contraindication for biopsy of the graft;
- No contraindication to the injection of SonoVue ®:
- hypersensitivity to sulfur hexafluoride
- acute coronary syndrome, unstable ischemic heart disease (myocardial infarction phase formation or evolution, typical resting angina in the previous 7 days, significant worsening of cardiac symptoms in the previous 7 days, recent intervention on the coronary arteries or another factor suggesting clinical instability (eg, recent deterioration of ECG changes in clinical or laboratory parameters), acute heart failure, stage III or IV heart failure, severe arrhythmias.
- right-left shunt, severe pulmonary hypertension (PAP\> 90 mmHg), uncontrolled systemic hypertension, respiratory distress syndrome
- Affiliated to a social security scheme
Exclusion
- Refusal to participate in the study;
- Inability / refusal to give informed consent;
- contraindication for biopsy testing graft;
- Presence of a contraindication to the injection of SonoVue ®.
- Presence of a peripheral venous access in a non-restricted already infused patient, not pickable under ultrasound
- Breastfeeding, pregnancy
Key Trial Info
Start Date :
March 19 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 19 2016
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT02201537
Start Date
March 19 2013
End Date
March 19 2016
Last Update
November 20 2025
Active Locations (1)
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1
NECKER Hospital
Paris, France, 75015