AKI Prevention and Early Intervention in Patients Undergoing VAD Placement

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Avoidance of potentially nephrotoxic agents. Optimizing volume status (avoidance of volume overload or depletion) Optimizing electrolytes and acid-base status Minimizing IV contrast exposure when appropriate Treating severe anemia Optimization of hemodynamics (Mean arterial BP>65mmHg). 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.

Official Title
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AKI Prevention and Early Intervention in Patients Undergoing VAD Placement

Conditions
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Kidney Injury

Intervention / Treatment
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* Other: Clinical Recommendations


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Adult patients that will undergo VAD placement. Patients able to give consent Exclusion criteria: Patients on dialysis (hemodialysis or peritoneal dialysis) Non-elective VAD placement (VAD implantation decision made within 24 hours)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Open label single group interventional study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Subjects Undergoing Prospective VAD<br>Patients undergoing VAD placement. The investigators will provide clinical recommendations to the subject's primary care provider. | Other: Clinical Recommendations<br>* The investigators will provide clinical recommendations to the subject's primary care provider. These will be in regards to the following: Avoidance of potentially nephrotoxic medications. Optimizing volume status (avoidance of volume overload or depletion) Optimizing electrolytes and acid-base status Minimizing IV contrast exposure when appropriate Treating severe anemia Optimization of hemodynamics (Mean arterial BP>65mmHg)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ventricular Assist Device