血液透析におけるカリウム制限の証拠 (EvoKe-HD)
EvoKe-HD is a pilot randomized controlled trial to assess the feasibility and potential for efficacy of a novel dietary approach to hyperkalemia. Contrary to the traditional recommendations limiting the intake of high-potassium whole foods, such as fruits and vegetables, the investigators propose to switch the focus to foods containing potassium that is readily absorbed by the body (high bioavailability), such as potassium from additives, processed meats, milk, fruit juices and sugary drinks.
調査の概要
状態
詳細な説明
Sixty adults receiving hemodialysis treatments with blood potassium levels ≥ 5.2 mmol/L on two occasions or more in the past three months will be randomly assigned to either the novel dietary counselling or the traditional approach. Both groups will meet with the renal dietician again once a month for 20 to 30 minutes, but the content of the recommendations will be different. The intervention and follow-up period will last three months. The investigators will record pre-dialysis potassium, bicarbonate, phosphorus, calcium and parathormone levels, blood pressure, volume status, hospitalizations, medication, and dialysis prescription changes monthly and assess nutritional status and satisfaction with food at the beginning and at the end of the study.
The study will be successful if 30% or more of the eligible patients agree to participate and complete the 3-month assessment.
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
-
-
Quebec
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Montreal、Quebec、カナダ、H4J 1C5
- CIUSSS du Nord-de-l'Île-de-Montréal
-
-
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:
- ≥18 years or older
- Receiving hemodialysis 3 times/week for ≥ 3 months
- Has at least two pre-dialysis serum potassium levels ≥5.2 mmol/L on any analysis in the past 3 months OR the most recent pre-dialysis serum potassium value ≥ 4.6 mmol/L and is currently prescribed a potassium-binding agent at a regular frequency (defined as ≥ once per week).
- Can speak and understand French or English
- Has not missed more than 1 dialysis session in the previous 3 months.
- Is capable of providing informed consent.
Exclusion Criteria:
- Is not expected to survive beyond 6 months
- Does not control their dietary intake (e.g., residents of high-dependency nursing homes)
- Significant cognitive impairment precluding understanding of the dietary recommendations.
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Restriction high bioavailability potassium sources
Participants will be asked to identify and avoid food items with potassium additives by revising the ingredient lists of the grocery products they consume. They will also be asked to reduce two sources of high bioavailability potassium, such as meat, milk, fruit juices, processed potatoes or coffee. |
Participants will be asked to identify and avoid food items with potassium additives by revising the ingredient lists of the grocery products they consume. They will also be asked to reduce two sources of high bioavailability potassium, such as meat, milk, fruit juices, processed potatoes or coffee. |
|
アクティブコンパレータ：Control
Participants will be asked to reduce the intake of food items with high total potassium content. A list of moderate-to-high potassium food items will be provided to the participants. |
Participants will be asked to reduce the intake of food items with high total potassium content. A list of moderate-to-high potassium food items will be provided to the participants. |
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 |
|---|---|---|
|
研究期間中の平均週中透析前カリウム値の変化
時間枠：3ヶ月
|
3ヶ月
|
|
|
Percentage of prevalent dialysis patients recruited and retained for 3 months
時間枠：3 months
|
Primary feasibility outcome |
3 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
平均月間週中透析前血清カリウムレベル（mmol/L）
時間枠：3ヶ月
|
3ヶ月
|
|
|
研究期間中の最高血清カリウム値
時間枠：3か月
|
3か月
|
|
|
高カリウム血症（≥5.6 mmol/L）および重度高カリウム血症（>6 mmol/L）イベント数
時間枠：3ヶ月
|
3ヶ月
|
|
|
透析液濃度 < 2mmol/L の透析セッション数
時間枠：3ヶ月
|
3ヶ月
|
|
|
カリウム透析液濃度を上昇または低下させた患者数（≥0.5mmol/L以上）
時間枠：3ヶ月
|
3ヶ月
|
|
|
試験期間中のカリウム吸着剤の総投与量（g）
時間枠：3か月
|
3か月
|
|
|
3か月時点でのカリウム吸着薬服用参加者数
時間枠：3ヶ月
|
3ヶ月
|
|
|
高カリウム生体利用度項目（肉類、乳製品、ジュース、ジャガイモ）の1日当たりの摂取回数
時間枠：3ヶ月
|
3ヶ月
|
|
|
中程度から高程度の総カリウム含有食品の1日あたりの摂取回数
時間枠：3か月
|
3か月
|
|
|
植物性タンパク質と動物性タンパク質の摂取比率（g/g）
時間枠：3ヶ月
|
3ヶ月
|
|
|
アルブミン値（g/L）
時間枠：3か月
|
3か月
|
|
|
ボディマス指数（kg/m²）
時間枠：3ヶ月
|
3ヶ月
|
|
|
体重変化（kg）
時間枠：3ヶ月
|
3ヶ月
|
|
|
月間平均平日透析前血清リン酸値（mmol/L）
時間枠：3か月
|
3か月
|
|
|
週中透析前血清カルシウム平均月間値 (mmol/L)
時間枠：3ヶ月
|
3ヶ月
|
|
|
透析前血清副甲状腺ホルモンレベル (pmol/L)
時間枠：3ヶ月
|
3ヶ月
|
|
|
月間平均血清重炭酸塩レベル（mmol/L）
時間枠：3ヶ月
|
3ヶ月
|
|
|
透析間体重増加（kg／日）
時間枠：3ヶ月
|
3ヶ月
|
|
|
1週間平均透析前血圧（mmHg）
時間枠：3か月
|
3か月
|
|
|
Ratio of the number of randomized participants over the number of screened participants randomized
時間枠：3 months
|
Secondary feasibility outcome |
3 months
|
|
Number of participants recruited 12 months into the trial
時間枠：3 months
|
Secondary feasibility outcome |
3 months
|
|
Percentage of randomized participants who report having understood the dietary recommendations well or very well using a 1-7 Likert scale with anchors
時間枠：3 months
|
Secondary feasibility outcome |
3 months
|
|
Percentage of randomized participants who judge the intervention to be acceptable using a 1-7 Likert scale with anchors
時間枠：3 months
|
Secondary feasibility outcome |
3 months
|
|
Healthy diet index 2020
時間枠：3 months
|
Include 13 components that reflect the key recommendations in the Dietary Guidelines for Americans, 2020-2025. The maximum score is 100. |
3 months
|
|
Mediterranean diet score
時間枠：3 months
|
0 to 100 score; higher score represents a better adherence to the Mediterranean diet |
3 months
|
|
Mediterranean-diet scale
時間枠：3 months
|
Score from 0 (minimal adherence to the traditional Mediterranean diet) to 9 (maximal adherence) |
3 months
|
|
Subjective global assessment
時間枠：3 months
|
Standardized subjective assessment of nutritional status performed by a dietitian. Final rating is either Well-nourished, Mildly/moderately malnourished or Severely malnourished with or without cachexia and/or sarcopenia. |
3 months
|
|
Normalized protein nitrogen appearance (g/kg/day)
時間枠：3 months
|
calculated from urea reduction ratio |
3 months
|
|
Satisfaction with food-related life
時間枠：3 months
|
5-item scale, total score range 0 to 100, higher score represents higher satisfaction with food |
3 months
|
|
Self-perceived impact on diet
時間枠：3 months
|
"I changed my diet in the past 3 months based on the advice I received from the renal dietitian" (1-7 Likert scale with anchors) |
3 months
|
|
Self-perceived compliance with the dietary recommendations
時間枠：3 months
|
"I am following the diet recommended by the renal dietitian" (1-7 Likert scale with anchors) |
3 months
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
全死因死亡
時間枠：3ヶ月
|
3ヶ月
|
|
|
Major cardiovascular events
時間枠：3 months
|
Composite of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death |
3 months
|
|
Standardised Outcomes in NephroloGy fatigue measure
時間枠：3 months
|
3 questions answered on a 4-points Likert scale. The results of each question (rated 0 to 3) is summed up to obtain to total score (range 0 to 9) |
3 months
|
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 (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
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