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The investigators are doing this research to find out if more careful assessment and elimination of potential risk factors of acute kidney injury (AKI) during the subject's perioperative period will reduce their chance of kidney damage and kidney damage related problems.
The purpose of the study is to investigate whether preventive measures for patients undergoing ventricular assist device (VAD) placement will reduce AKI occurrence, progression and associated complications.
Participants will be in the study for a total of 6 days (1 day prior to the surgery and 5 days after the surgery). The investigators will review the participant's medical record up to one year after surgery.
The study investigators will access the participant's electronic medical record 24 hours prior to the planned VAD implantation and review the participant's medication regimen and provide recommendations to the participant's primary care physician in an effort to minimize potential risks for AKI. There will be no intervention during the operation.
The clinical recommendations will cover the following:
The investigators plan to compare the results of this study with the historical data in the same patient population in the years of 7/1/2015-6/30/2017.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects Undergoing Prospective VAD | Other | Patients undergoing VAD placement. The investigators will provide clinical recommendations to the subject's primary care provider. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical Recommendations | Other | The investigators will provide clinical recommendations to the subject's primary care provider. These will be in regards to the following:
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of postoperative AKI (within 5 post-op days) based on AKIN criteria | The Acute Kidney Injury Network (AKIN) staging system has 3 stages: 1) serum creatinine increase ≥ 26.5 umol/L or increase to 1.5-2.0 fold from baseline, OR urine output <0.5 ml/kg/h for 6 h; 2) serum creatinine increase > 2.0-3.0 fold from baseline OR urine output <0.5 ml/kg/h for 12 h; 3) serum creatinine increase >3.0 fold from baseline OR serum creatinine ≥354 umol/l with an acute increase of at least 44 umol/l or need for Renal Replacement Therapy (RRT) OR urine output <0.3 ml/kg/h for 24 h OR anuria for 12 OR need for RRT | 5 days after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of postoperative AKI (within 5 post-op days) based on AKIN criteria | The AKIN staging system has 3 stages: 1) serum creatinine increase ≥ 26.5 umol/L or increase to 1.5-2.0 fold from baseline, OR urine output <0.5 ml/kg/h for 6 h; 2) serum creatinine increase > 2.0-3.0 fold from baseline OR urine output <0.5 ml/kg/h for 12 h; 3) serum creatinine increase >3.0 fold from baseline OR serum creatinine ≥354 umol/l with an acute increase of at least 44 umol/l or need for Renal Replacement Therapy (RRT) OR urine output <0.3 ml/kg/h for 24 h OR anuria for 12 OR need for RRT |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qi Qian, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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Open label single group interventional study
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| 5 days after the surgery |
| Length of hospital stay | The length of hospital stay will be determined from the electronic medical record. | 1 year after the surgery |
| In hospital (perioperative) mortality and one-year mortality | The number of subjects who died in hospital (perioperatively) and one year after surgery | Approximately 5 days after surgery, one year after enrollment |