Contrast-Enhanced US of Spleen, Liver and Kidney
Recruitment status was Recruiting
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Purpose
To evaluate the changes in the microcirculation of the liver, kidney and spleen during acute infection in patients with malaria (cohorts 1 and 3) and other infectious diseases such as acute pyelonephritis at day 0 (within 8 hours of the treatment start), day 2 to 4 and day 28-32, using functional US with continuous infusion of a contrast agent (SonoVue, Bracco, Italy).
Study hypothesis: malaria patients should exhibit a different pattern of enhancement, particularly when quantitative measurements of the SU signals is performed with destruction reperfusion kinetics.
| Study Type: | Observational |
| Study Design: | Observational Model: Defined Population Observational Model: Natural History Time Perspective: Longitudinal Time Perspective: Prospective |
| Official Title: | Contrast-Enhanced US of Spleen, Liver and Kidney in Patients With Acute Infection (Malaria and Other Infectious Diseases: a Functional Study |
| Estimated Enrollment: | 53 |
| Study Start Date: | August 2005 |
To evaluate the changes in the microcirculation of the liver, kidney and spleen during acute infection in patients with malaria (cohorts 1 and 3) and other infectious diseases such as acute pyelonephritis at day 0 (within 8 hours of the treatment start), day 2 to 4 and day 28-32, using functional US with continuous infusion of a contrast agent (SonoVue, Bracco, Italy).
Three cohortes will be studied: cohorte 1 infection at Plasmodium falciparum (24 patients), cohorte 3 infection at Plasmodium vivax, ovale or malariae (5 patients) and cohorte 2 other infectious diseases such as acute pyelonephritis (24 patients).
Study hypothesis: malaria patients should exhibit a different pattern of enhancement, particularly when quantitative measurements of the SU signals is performed with destruction reperfusion kinetics.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Social security number
- Age over 18
- acute malaria infection or other infectious diseases
- Inpatients
- Signed informed consent form
Exclusion Criteria:
- Pregnancy
- Criteria of bad tolerance of infection
- Treatment started for more than 8 hours
- Lack of cooperation
- History of splenectomy, hematological disease, cirrhosis with portal hypertension, splenomegaly
- Medical treatment with beta blocker, diuretic, immunodepression drugs
Contacts and Locations| Contact: Olivier Lortholary, MD PhD | 33-1-44-49-41-42 | olivier.lortholary@nck.ap-hop-paris.fr |
| France | |
| Department of Adult Radiology, Necker University Hospital | Recruiting |
| Paris, Ile de france, France, 75015 | |
| Contact: Jean-Michel Correas, MD PhD 33-1 44 49 41 40 jean-michel;correas@nck.aphp.fr | |
| Principal Investigator: Jean-Michel Correas, MD PhD | |
| Sub-Investigator: Dominique Joly, MD PhD | |
| Sub-Investigator: Olivier Lortholary, MD PhD | |
| Principal Investigator: | Jean-Michel Correas, MD PhD | Necker University Hospital |
| Study Director: | Pierre Buffet, MD PhD | Centre Médical – Institut Pasteur |
| Study Director: | Olivier Lortholary, MD PhD | Necker University Hospital |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00190281 History of Changes |
| Other Study ID Numbers: | 04 025 |
| Study First Received: | September 13, 2005 |
| Last Updated: | December 12, 2005 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
FUNCTIONAL STUDY CONTRAST-ENHANCED US PERFUSION |
Additional relevant MeSH terms:
|
Bacterial Infections Malaria Pyelonephritis Protozoan Infections Parasitic Diseases |
Nephritis, Interstitial Nephritis Kidney Diseases Urologic Diseases Pyelitis |
ClinicalTrials.gov processed this record on June 17, 2013