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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Ernest Ayers, MSPH
- 전화번호: 206-685-1423
- 이메일: ayerse@uw.edu
연구 연락처 백업
- 이름: Luisa Rios-Avila
- 전화번호: 206-258-9325
- 이메일: lrios1@uw.edu
연구 장소
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Washington
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Seattle, Washington, 미국, 98112
- Northwest Kidney Centers
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연락하다:
- Luisa Rios-Avila
- 전화번호: 2062589325
- 이메일: lrios1@uw.edu
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-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 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.
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Ultrafiltration for 4 or 8 weeks compared to no ultrafiltration.
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활성 비교기: 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.
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Ultrafiltration for 4 or 8 weeks compared to no ultrafiltration.
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간섭 없음: Control arm, no ultrafiltration sessions
Participant receives only their regularly scheduled thrice weekly hemodialysis treatments.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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24-hour continuous ambulatory blood pressure
기간: Measurement performed at baseline compared to measurement performed at 24 weeks.
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Blood pressure measured continously for a 24-hour period by wearing a blood pressure cuff on the upper arm.
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Measurement performed at baseline compared to measurement performed at 24 weeks.
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Symptoms of congestion.
기간: Questionnaire taken at Baseline compared the the questionnaire taken at 24 weeks.
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Change in sypmtoms of congestion caused by fluid overload which we will access by using the Kidney-modified Kansas City Cardiomyopathy Questionnaire.
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Questionnaire taken at Baseline compared the the questionnaire taken at 24 weeks.
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공동 작업자 및 조사자
수사관
- 수석 연구원: Bryan Kestenbaum, MD, MS, University of Washington
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- STUDY00025083
- R01DK141693 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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 공유 기간
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- ANALYTIC_CODE
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Ultrafiltration에 대한 임상 시험
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University Hospital, GenevaPamukkale University; Hospices Civils de Lyon; Hospital Clinic of Barcelona; German Heart Institute 그리고 다른 협력자들알려지지 않은심혈관 질환 | 비투석 의존성 중증 신장 기능 장애독일, 프랑스, 스페인, 스위스, 칠면조