Dry Weight Reduction Intervention Via Extra Ultrafiltration (DRIVE-UF)
Most patients who receive hemodialysis treatments have excess fluid in their body that has slowly built up over the course of kidney disease. This extra fluid is the main cause of high blood pressure in dialysis and leads to stress on the heart and lungs.that causes debilitating symptoms and frequent hospitalizations.
This trial will test whether a focused program of 4 or 8 weeks of extra ultrafiltration treatments can remove most of this extra fluid. We believe that getting rid of large amounts of extra fluid will result in sustained improvements in blood pressure and symptoms. Ultrafiltration is a gentler type of dialysis that removes fluid but does not clean the blood.
調査の概要
詳細な説明
This is a randomized trial of patients who are receiving in-center hemodialysis treatments for end stage kidney disease and have clinical suspicion of fluid overload. Enrolled participants will be randomly assigned in 1:1:1 fashion to either a four-week ultrafiltration strategy, an eight-week ultrafiltration strategy, or continuation of their regular thrice weekly hemodialysis treatments. Each ultrafiltration strategy will add two extra four-hour ultrafiltration treatments per week plus pharmacist-guided tapering of blood pressure medications. We will test the impact of these strategies on primary outcomes of
- Change in 24-hour continuous ambulatory blood pressure from baseline to 24-weeks
- Change in symptoms of congestion from baseline to 24-weeks We will also test the impact of the treatment strategies on related symptoms, physical activity levels, hemodynamics. and measures of safety.
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：Ernest Ayers, MSPH
- 電話番号：206-685-1423
- メール：ayerse@uw.edu
研究連絡先のバックアップ
- 名前：Luisa Rios-Avila
- 電話番号：206-258-9325
- メール：lrios1@uw.edu
研究場所
-
-
Washington
-
Seattle、Washington、アメリカ、98112
- Northwest Kidney Centers
-
コンタクト：
- Luisa Rios-Avila
- 電話番号：2062589325
- メール：lrios1@uw.edu
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
Receiving thrice weekly in-center hemodialysis treatments for end stage kidney disease for at least four weeks and clinical suspicion of volume excess based on either:
Persistent hypertension defined by three consecutive pre-dialysis systolic blood pressures ≥140 mmHg or three consecutive pre-dialysis systolic blood pressures 130-140 mmHg plus use of at least two anti-hypertensive medications that can be tapered.
OR
Symptoms of congestion defined by a 12-item Kidney Modified Kansas City Cardiomyopathy Questionnaire (KM-KCCQ) score <75.
Exclusion Criteria:
- Age <18 years
- Receiving hemodialysis treatments for acute kidney injury
- Receiving hemodialysis treatments for less than four weeks
- Planned switch to peritoneal or home dialysis within next three months
- Current or planned incremental hemodialysis (less than 3 treatments per week)
- Current or planned intensive hemodialysis (four or more treatments per week)
- Scheduled kidney transplantation
- Major cardiovascular or bleeding event within previous 90 days
- Receiving chemotherapy or radiation treatment for cancer
- History of cirrhosis with ascites
- Inability to complete 24-hour ambulatory blood pressure measurement
- Wheelchair dependance or other inability to complete six-minute walk test
- Pre-dialysis systolic blood pressure <100 mmHg
- Scheduled use of midodrine with hemodialysis treatments
- History of non-adherence with dialysis treatments
- Pregnancy
- Institutionalized
- Current or pending enrollment in hospice care
- Inappropriate for enrollment based on investigator or nephrologist discretion
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：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 |
|---|---|
|
アクティブコンパレータ：Ultrafiltration sessions for 4 weeks
Two ultrafiltration sessions per week plus pharmacist guided tapering of blood pressure medications in addition to the regular thrice weekly hemodialysis treatments.
|
Ultrafiltration for 4 or 8 weeks compared to no ultrafiltration.
|
|
アクティブコンパレータ：Ultrafiltration sessions for 8 weeks
Two ultrafiltration sessions per week plus pharmacist guided tapering of blood pressure medications in addition to the regular thrice weekly hemodialysis treatments.
|
Ultrafiltration for 4 or 8 weeks compared to no ultrafiltration.
|
|
介入なし：Control arm, no ultrafiltration sessions
Participant receives only their regularly scheduled thrice weekly hemodialysis treatments.
|
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 |
|---|---|---|
|
24-hour continuous ambulatory blood pressure
時間枠：Measurement performed at baseline compared to measurement performed at 24 weeks.
|
Blood pressure measured continously for a 24-hour period by wearing a blood pressure cuff on the upper arm.
|
Measurement performed at baseline compared to measurement performed at 24 weeks.
|
|
Symptoms of congestion.
時間枠：Questionnaire taken at Baseline compared the the questionnaire taken at 24 weeks.
|
Change in sypmtoms of congestion caused by fluid overload which we will access by using the Kidney-modified Kansas City Cardiomyopathy Questionnaire.
|
Questionnaire taken at Baseline compared the the questionnaire taken at 24 weeks.
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Bryan Kestenbaum, MD, MS、University of Washington
研究記録日
主要日程の研究
研究開始 (推定)
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
- STUDY00025083
- R01DK141693 (米国 NIH グラント/契約)
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
All data and samples will be stored indefinitely for possible future uses. There will be no direct or indirect identifiers stored with the resources after this study is finished.
Resources will be coded with study codes. We plan post de-identified data in public databases such as Dryad at study conclusion.
NIH data sharing policies typically require us to post coded, deidentified individual-level data on one of the preferred platforms. We will work with our NIH project officer to post data after the study is finished to an appropriate platform.
We may collaborate with colleagues and other researchers who demonstrate a legitimate research need for which data and samples from this study would be valuable.
Future uses do not have any restrictions.
IPD 共有時間枠
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
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
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。