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This study aims to determine if the CloudCath device can detect infections related to peritoneal dialysis (peritonitis) as fast or faster than the current standard methods used by patients and doctors to detect such infections.
This study will evaluate the safety and effectiveness of the CloudCath System to detect the onset of peritonitis as compared to standard of care.
Study Participants will connect the CloudCath System to their home peritoneal dialysis unit and the CloudCath System will analyze the effluent dialysis solution for changes associated with peritonitis. The system will alert the participant and healthcare provider if it detects a possible infection so they can be formally diagnosed by their healthcare provider.
Following enrollment, Study Participants will use the CloudCath System for 12 continuous months.
Study results from the ACT study will be compared to the results of the CATCH Study (Protocol number CC-P-001; NCT04515498). In CATCH, the Study Participants used a CloudCath System; however, the notification capabilities (per the CloudCath System algorithm) were deactivated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CloudCath detection | Experimental | Active monitoring of dialysate effluent by the CloudCath System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CloudCath System | Device | The CloudCath System enables drainage and measures turbidity, reported as a numeric score, in peritoneal dialysate effluent. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to peritonitis diagnosis | The time between detection by the CloudCath System and laboratory confirmation of peritonitis. | 12-months |
| Measure | Description | Time Frame |
|---|---|---|
| Agreement in peritonitis detection between the CloudCath System and clinical criteria. | clinical criteria include: white blood cells (WBC) (>100 cells per microliter or >0.1 x10^9/L), polymorphonuclear cells (PMN) (>50%), microbiology culture results, gram staining, and peritonitis symptoms | 12-months |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brian Fisher | Contact | +1 (415) 651-3393 | brian@cloudcath.com | |
| Concetta Carbonaro | Contact | concetta@cloudcath.com |
| Name | Affiliation | Role |
|---|---|---|
| Glenn Chertow, MD | Stanford University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dialysis Center of Western Massachusetts Llc | Recruiting | Chicopee | Massachusetts | 01020 | United States |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D010538 | Peritonitis |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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All study participants receive a CloudCath Device and use it at home adjunctively to their regular peritoneal dialysis system.
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| Agreement in detection of clinically actionable events between the CloudCath System and laboratory reports and/or diagnosis |
Clinically actionable events defined as an event which requires treatment (i.e., prescribing medications, cleaning an exit site, etc) or intervention (i.e., PD catheter manipulation, removal). Events of interest for this protocol include, but are not limited to, peritonitis, exit site or tunnel infection, and peritoneal dialysis (PD) catheter dysfunction (including PD catheter-related bleeding and PD catheter-related drainage issues). |
| 12-months |
| Agreement in detection of clinically relevant events based on CloudCath System, as compared to clinical laboratory results or diagnosis of a clinically relevant event. | Clinically relevant events are defined as clinically actionable events, events treated preventatively or medically relevant events. | 12-months |
| Sensitivity and Specificity of the CloudCath System to detect peritonitis as compared to diagnostic laboratory testing | Analysis of sensitivity and specificity of CloudCath System detection of peritonitis, as compared to diagnostic laboratory testing | 12-months |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D010532 | Peritoneal Diseases |
| D004066 | Digestive System Diseases |