慢性腎疾患段階の患者の間で、ポイントオブケアAI対応ECGデバイスを使用した高カリウム血症のモニタリング3-5 (POCKET)
慢性腎臓病の患者の間でポイントオブケアAI対応ECGデバイスを使用した高カリウム血症3〜5症の高カリウム血症のモニタリング - 高カリウム血症の割合を減らす - 実用的な無作為化臨床試験
The clinical trial will be conducted in a real-world outpatients setting with the goal of learning if monitoring serum potassium frequently among patients with moderate-to-advanced stages of chronic kidney disease leading to optimal management of hyperkalemia (the reduced occurrence of serum potassium ≥ 5.0 mmol/L during 6 months of follow-up). It will also learn about the adherence of using a mobile monitoring device.
Participants will:
- Measure their serum potassium using an AI-enhanced point-of-care ECG device at least twice per week
- Receive health education prompts to reduce intake of potassium rich foods if their electrocardiogram device measured serum potassium is abnormal
- Receive alerts to visit nephrology clinic if their electrocardiogram device measured serum potassium is continuously abnormal
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Jinwei Wang, Ph.D.
- 電話番号：+86-010-83572388
- メール：wangjinwei@bjmu.edu.cn
研究場所
-
-
Beijing Municipality
-
Beijing、Beijing Municipality、中国、100034
- 募集
- Peking University First Hospital
-
コンタクト：
- Jinwei Wang, Ph.D.
- 電話番号：+86-010-83572388
- メール：wangjinwei@bjmu.edu.cn
-
-
Guangxi
-
Nanning、Guangxi、中国、530021
- まだ募集していません
- The First Affiliated Hospital of Guangxi Medical University
-
コンタクト：
- Ling Pan, M.D.
- 電話番号：+86-0771-5356533
- メール：nnpanling008@sina.com
-
-
Hubei
-
Wuhan、Hubei、中国、430063
- まだ募集していません
- Hubei Provincial Hospital of TCM
-
コンタクト：
- Xue Xue, M.D.
- 電話番号：+86-027-88710029
- メール：2672754432@qq.com
-
-
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:
- Patients with chronic kidney disease stages 3b-5 (eGFR: 10 - <45 ml/min/1.73m²)
- Patients with regular visits in the study sites to manage their chronic kidney disease (≥ 1 visit per 3 months during the past year before enrollment)
- Willingness to participate in the study with signed informed consent
Exclusion Criteria:
- Patients already under kidney replacement therapy or will receive kidney replacement therapy in 6 months
- Unwillingness or without the ability to monitor hyperkalemia using the study device
- Patients with heart pacemaker implanted
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：ランダム化
- 介入モデル：並列代入
- 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 |
|---|---|
|
実験的：Monitoring plasma potassium using ECG device
Patients in this arm will use AI-enhanced point-of-care ECG device to monitor their serum potassium level every 3 days for 6 months in addition to their regular outpatients follow-up. If ECG device detected hyperkalemia was reported, more intensive monitoring, education on diet or offer of making outpatient appointment, as appropriate, will be provided. |
A mobile AI-enhanced electrocardiogram device will be used to help patients monitor hyperkalemia. The device, shaped like a stick of chewing gum, collects time-series data of electrocardiogram lead I through two electrodes. Deep convolutional neural network algorithm can read the data and generated categories of plasma potassium (<5 mmol/L, 5 - <5.5 mmol/L, 5.5 - <6.0 mmol/L and ≥ 6.0 mmol/L). Study participants receive the device after randomization. The staff establishes a WeChat group for each participant and reminds them to monitor plasma potassium every 3 days. When the detected plasma potassium category falls in 5 - <5.5 mmol/L, they will be reminded to watch diet and to verify plasma potassium again. More intensive reminding (once daily) will be sent if plasma potassium category falls in 5.5 - <6.0 mmol/L or ≥ 6.0 mmol/L. An extra outpatient appointment will also be made as soon as possible for the patients when their detected plasma potassium category is ≥ 6.0 mmol/L. |
|
介入なし：Regular outpatients follow-up
Patients in this arm will just follow their regular outpatients care without additional intervention. |
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 |
|---|---|---|
|
Incidence of serum potassium ≥ 5.0 mmol/L
時間枠：Six months (+1 month if outpatients visit delayed) after enrollment into the study
|
The serum potassium should be the laboratory measured one, which is obtained in the 3(±1) month and 6(±1) month follow-up in outpatients visit. |
Six months (+1 month if outpatients visit delayed) after enrollment into the study
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Average level of serum potassium
時間枠：Six month (+1 month if outpatients visit delayed) after enrollment into the study
|
The serum potassium should be the laboratory measured one, which is obtained in the 3(±1) month and 6(±1) month follow-up in outpatients visit. |
Six month (+1 month if outpatients visit delayed) after enrollment into the study
|
|
Frequency of using AI-enhanced ECG device to monitor serum potassium
時間枠：Six months (+1 month if outpatients visit delayed) after enrollment into the study and 3 months (+1 month if outpatients visit delayed) after the 6 months of intervention.
|
The frequency will be monitored in intervention period for the intervention group and after intervention (up to 4 months) for both the original intervention and control groups. |
Six months (+1 month if outpatients visit delayed) after enrollment into the study and 3 months (+1 month if outpatients visit delayed) after the 6 months of intervention.
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of serum potassium ≥ 5.0 mmol/L after the intervention period
時間枠：Three months (+1 month if outpatients visit delayed) after the 6 months of intervention
|
We collect incidence of serum potassium ≥ 5.0 mmol/L after the intervention period to see whether there is still a gap between the original intervention and control groups with the latter one having obtained the device. |
Three months (+1 month if outpatients visit delayed) after the 6 months of intervention
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2024-943
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD used in the results publication will be shared upon reasonable request.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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