AKI Prevention and Early Intervention in VAD Patients Admitted for Acute Medical Events.
調査の概要
詳細な説明
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
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Arizona
-
Scottsdale、Arizona、アメリカ、85259
- Mayo Clinic in Arizona
-
-
Florida
-
Jacksonville、Florida、アメリカ、32224
- Mayo Clinic in Florida
-
-
Minnesota
-
Rochester、Minnesota、アメリカ、55905
- Mayo Clinic in Rochester
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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).
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：Subjects with VAD in place
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.
|
The clinical recommendations will regard the following:
None of the suggestions will be experimental. All suggestions will be based on standard nephrology practice. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Rate of AKI in hospitalized VAD patients based on AKIN criteria
時間枠：The first 7 days of hospitalization
|
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
時間枠：The first 7 days of the hospitalization
|
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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Length of hospital stay
時間枠：One year after hospitalization
|
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
時間枠：One year after enrollment
|
The number of subjects who died during hospitalization, 60 days after hospitalization and one year after hospitalization
|
One year after enrollment
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Qi Qian、Mayo Clinic
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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