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NCT01407367 · ClinicalTrials.gov registry record
Safe Kidney Care Cohort Study
A clinical trial, sponsored by University of Maryland, Baltimore.
- Completed
- Registry status
- 350
- Enrollment target
NCT01407367: Completed study, sponsored by University of Maryland, Baltimore.
NCT01407367 is a clinical trial that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 350 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01407367 has completed, sponsored by University of Maryland, Baltimore.
- COMPLETED
- Registry status
- 350 participants
- Enrollment target
Study Summary
Chronic kidney disease (CKD) is common, but it is often over-looked in patients with this disease when they are getting medical treatment. Patients with CKD have special needs for their medical treatment. When these special needs are not considered their medical care may lead to unintended harm (called safety events) which can cause hospitalization, more kidney problems, and even death. This research study has two purposes. The first purpose is to determine how participants feel about wearing a medical alert bracelet or necklace that alerts health care workers that the user of the bracelet or necklace has decreased kidney function. Medical alert bracelets are often recommended for people who have other medical problems, such as diabetes. This medical alert bracelet or necklace has an address to an informational website about the safe care of patients with kidney problems. The investigators think that alerting health care workers that a person has decreased kidney function may decrease their chances of having a medical injury and improve the safety of their care. The second purpose of this research study is to track how often people with kidney problems may be exposed to medicines, tests, or procedures that might increase their chance of having an accidental medical injury or safety event. Though some medical injuries can not be prevented, the investigators want to find out what medical events in patients with kidney problems might be preventable. The investigators also want to find out if other things might increase a patient's chances of getting a medical injury, such as physical weakness or medical instructions that might be confusing.
Primary Outcome
The discrete incidence of any of the following CKD-PSIs endorsed by the consensus expert panel: Class I events: Incidence of patient reported adverse events related to medical care or medicines incuding: Falling, Bleeding, Edema, Angioedema, Confusion or altered mental status, Rhabdomyolysis Class II events: Incidence of adverse events detected at annual study visits such as: Hyperkalemia, Hypokalemia, Hypoglycemia, Hyperglycemia, Orthostatic Hypotension, Hypotension, Hypertension, Bradycardia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 350 participants |
| Start Date | 2011-04 |
| Est. Completion | 2017-07 |
What the finished NCT01407367 record still lists
NCT01407367 is an observational study that tracks outcomes without assigning an intervention. The registered 350 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01407367 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01407367 about?
NCT01407367 is a clinical study titled "Safe Kidney Care Cohort Study". Chronic kidney disease (CKD) is common, but it is often over-looked in patients with this disease when they are getting medical treatment. Patients with CKD have special needs for their medical treatment. When these special needs are not considered their medical care may lead to unintended harm (cal...
What is the current status of trial NCT01407367?
This trial is currently completed. The enrollment target is 350 participants. The study started on 2011-04. Estimated completion is 2017-07.
Who is sponsoring clinical trial NCT01407367?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
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