Acute Kidney Injury Clinical Trial
Official title:
Clinical Values of Automated Electronic Alert for Acute Kidney injury-a Prospective ,Randomly Controlled Cohort Study
| NCT number | NCT02793167 |
| Other study ID # | GGH2016-1 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | March 2016 |
| Est. completion date | June 2022 |
| Verified date | February 2023 |
| Source | Guangdong Provincial People's Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Acute kidney injury (AKI) is common, serious and expensive.It is associated with significant mortality, morbidity and increased length of hospital stay.To improve clinical outcomes of AKI by early detection and timely referral to the renal,the investigators developed an electronic alert system which identifies all cases of AKI occurring in patients over 18 years.The system was also designed to collect data on AKI incidence one of the biggest tertiary hospital in China.
| Status | Completed |
| Enrollment | 2000 |
| Est. completion date | June 2022 |
| Est. primary completion date | December 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - adult patients with an Alert for AKI(based on KDIGO guidelines) Exclusion Criteria: - patients already on dialysis for AKI at the time of alert - patients with End stage renal disease - patients <18 years of age - patients dissenting from participation according to the Ethics application |
| Country | Name | City | State |
|---|---|---|---|
| China | Nephrology Dept,Guangdong General Hospital | Guangzhou | Guangdong |
| Lead Sponsor | Collaborator |
|---|---|
| XinLing Liang |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Adverse events during hospitalization | cardiac shock/ need for intensive care/ cardiopulmonary resuscitation/ cardiac death/ death | from start of AKI to discharge,up to 4 weeks | |
| Primary | Incidence of cardiovascular disease and its occurrence time followed up for 1 years | heart failure/ acute coronary syndrome/ readmission/cardiac readmission/ cardiovascular intervention or surgery | One year after discharge | |
| Primary | The AKI outcome and its occurrence time followed up for 1 years | AKI recovery/stop renal replacement therapy | One year after discharge | |
| Primary | AKI recovery/stop renal replacement therapy | Glomerular filtration rate decreased/ new occurrence proteinuria/ original proteinuria aggravation | from start of AKI to discharge,up to 4 weeks | |
| Secondary | Proportion of nephrology referral | from start of AKI to discharge,up to 4 weeks | ||
| Secondary | Diagnostic rate of AKI at discharge | from start of AKI to discharge,up to 4 weeks | ||
| Secondary | Follow-up rate after discharge | One year after discharge |
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