AKI Prevention and Early Intervention in VAD Patients Admitted for Acute Medical Events.

Study Overview
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Brief Summary
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The investigators are doing this research to investigate whether multifaceted preventive measures for newly hospitalized ventricular assist device (VAD) patients will reduce the Acute Kidney Injury (AKI) occurrence rate, progression and associated complications

Detailed Description
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The purpose of the study is to investigate whether preventive measures for newly hospitalized ventricular assist device (VAD) patients will reduce the Acute Kidney Injury (AKI) occurrence rate, progression and associated complications Participants will be in the study for the first 7 days of hospitalization. The study investigators will access the electronic medical record daily from admission day 1 through admission day 7 in order to provide clinical recommendations in an effort to minimize AKI risk as per routine practice. If the patient is discharged prior to day 7 the study, intervention will be terminated on day of discharge. The investigators will review the participant's medical record up to one year after surgery. This study will not include any experimental laboratory tests or experimental medication. The clinical recommendations will regard the following: Avoidance of potentially nephrotoxic medications (e.g. NSAIDs, intravascular contrast, nephrotoxic antimicrobials) Optimizing volume status (avoidance of volume overload or depletion) Optimizing electrolytes and acid-base status Optimizing hemodynamics (Mean arterial BP>65mmHg) Assessment of kidney function with serum creatinine and/or cystatin C None of the suggestions will be experimental. All suggestions will be based on standard nephrology practice. The investigators plan to compare the results of the current study with those in in the years of 2012-2017 (1/7/2012- 1/7/2017) via retrospective chart review

Official Title
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AKI Prevention and Early Intervention in VAD Patients Admitted for Acute Medical Events.

Conditions
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Acute 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 with VAD in place who are admitted to the hospital for acute medical illness during the study period. For those with multiple admissions during the study period only the first admission will be studied. Patients who are able to give consent. In case of patients that are mentally impaired we will obtain consent from power of attorney and when patients regain intact mental capacity we will reobtain consent from the patient. Exclusion criteria: Patients on dialysis (hemodialysis or peritoneal dialysis).

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 with VAD in place<br>Adult patients with VAD in place who are admitted to the hospital for acute medical illness. The investigators will provide clinical recommendations to the subject's primary care provider. | Other: Clinical Recommendations<br>* The clinical recommendations will regard the following: Avoidance of potentially nephrotoxic medications (e.g. NSAIDs, intravascular contrast, nephrotoxic antimicrobials) Optimizing volume status (avoidance of volume overload or depletion) Optimizing electrolytes and acid-base status Optimizing hemodynamics (Mean arterial BP>65mmHg) Assessment of kidney function with serum creatinine and/or cystatin C None of the suggestions will be experimental. All suggestions will be based on standard nephrology practice.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of AKI in hospitalized VAD patients 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 | The first 7 days of hospitalization | 
| Severity of AKI based on AKIN stages (I, II, III) 1 | 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 | The first 7 days of the hospitalization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay | The length of hospital stay will be determined from the electronic medical record. | One year after hospitalization | 
| In hospital, 60 day and one-year mortality | The number of subjects who died during hospitalization, 60 days after hospitalization and one year after hospitalization | 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