Ignite Creation Date:
2024-05-06 @ 2:12 PM
Last Modification Date:
2024-10-26 @ 1:27 PM
Study NCT ID:
NCT04246983
Status:
COMPLETED
Last Update Posted:
2022-12-20
First Post:
2020-01-24
Brief Title:
Point-of Care Ultrasound for Patients With HIV
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
Introducing Point-of-care Ultrasound at the Bedside for Diagnosing Opportunistic Diseases in Patients With HIV
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Rationale Point-of-care ultrasound POCUS is increasingly used by various specialists in the Netherlands but its role in managing patients with HIV is unclear In settings endemic for tuberculosis Fast Assessment with Sonography for HIVTuberculosis FASH has proven its value to detect extrapulmonary tuberculosis in patients with HIV However there is no data to support POCUS for patients with HIV in resource affluent settings
Objective The investigators aim to determine the feasibility and diagnostic value of POCUS in detecting opportunistic disease in HIV patients with advanced disease stages in the Netherlands
Study design The investigators will perform a prospective observational pilot study
Study population The investigators will include new adult patients with HIV presenting with a cluster of differentiation 4 CD4 T-cell count below 350 cellsmm3 and all adult HIV patients requiring admission to hospital Intervention if applicable The investigators will perform a focused ultrasound examination including FASH and ultrasound of the lung liver and kidneys In case of positive findings additional examinations will be undertaken to determine the underlying pathology andor treatment started as indicated In case of negative findings patients will be followed for 12 months to observe for possibly missed opportunistic infections
Main study parametersendpoints Our primary outcomes include acceptability of POCUS by patients interobserver variation in interpretation of POCUS images and number of diagnosed AIDS and non-AIDS related problems Secondary outcomes include sensitivity and specificity negative predictive value and positive predictive value of our POCUS protocol In addition incidence rates of opportunistic infections will be compared to a historical matched control group
Nature and extent of the burden and risks associated with participation benefit and group relatedness The ultrasound examination is painless and without risk to the participants It will take approximately 30 minutes and will be combined with routine visits to the hospital Benefits include potential earlier detection of opportunistic disease while adverse effects may arise from false positive findings requiring further examinations which may cause stress or anxiety The rate of false positive findings in POCUS has not been formally investigated but appears low The effect of POCUS in advanced HIVAIDS can only be studied in HIV patients
Objective The investigators aim to determine the feasibility and diagnostic value of POCUS in detecting opportunistic disease in HIV patients with advanced disease stages in the Netherlands
Study design The investigators will perform a prospective observational pilot study
Study population The investigators will include new adult patients with HIV presenting with a cluster of differentiation 4 CD4 T-cell count below 350 cellsmm3 and all adult HIV patients requiring admission to hospital Intervention if applicable The investigators will perform a focused ultrasound examination including FASH and ultrasound of the lung liver and kidneys In case of positive findings additional examinations will be undertaken to determine the underlying pathology andor treatment started as indicated In case of negative findings patients will be followed for 12 months to observe for possibly missed opportunistic infections
Main study parametersendpoints Our primary outcomes include acceptability of POCUS by patients interobserver variation in interpretation of POCUS images and number of diagnosed AIDS and non-AIDS related problems Secondary outcomes include sensitivity and specificity negative predictive value and positive predictive value of our POCUS protocol In addition incidence rates of opportunistic infections will be compared to a historical matched control group
Nature and extent of the burden and risks associated with participation benefit and group relatedness The ultrasound examination is painless and without risk to the participants It will take approximately 30 minutes and will be combined with routine visits to the hospital Benefits include potential earlier detection of opportunistic disease while adverse effects may arise from false positive findings requiring further examinations which may cause stress or anxiety The rate of false positive findings in POCUS has not been formally investigated but appears low The effect of POCUS in advanced HIVAIDS can only be studied in HIV patients
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None