Clinical Evaluation of Low Sodium Peritoneal Dialysis (PD) Solution on Hypertensive Patients Treated With PD (PDOne)
2015년 2월 26일 업데이트: Fresenius Medical Care Deutschland GmbH
Multicentric, Parallel, Controlled, Randomized, Single-blind Clinical Evaluation of New Low Sodium Peritoneal Dialysis Solution on Patients With Hypertension Treated With Continuous Ambulatory or Automated Peritoneal Dialysis
The aim of this study is to assess the superiority of the new low sodium peritoneal dialysis (PD) solution PDsol 12 in comparison with a conventional, already marketed solution, Gambrosol trio 40, in the treatment of the hypertensive peritoneal dialysis patients with aim to decrease hypertension and to improve the sodium/water balance.
연구 개요
상세 설명
Hypertension as well as sodium and water retention are common in end-stage renal disease patients on peritoneal dialysis and expose patients to left ventricular hypertrophy and increase cardiovascular mortality.
Moreover the poor control of dry weight and sodium/water balance results in increased morbidity. A previous low sodium study and computer simulations show that sodium removal can be improved with a low sodium fluid, which allows achieving a negative sodium balance without altering water balance.
The aim of this study is to assess whether treatment with one low sodium bag can substitute for one isotonic glucose bag every day in order to reduce the blood pressure and/or medication for hypertension, defined as the primary endpoint.
In order to evaluate the main criteria, blood pressure, a 24hours Ambulatory Blood Pressure Monitoring (ABPM) will be performed twice during the study, at Baseline and at 8 weeks of treatment, according to the EMEA guidance recommendations for anti-hypertensive treatments. In addition, the self measurement of blood pressure will be performed by patients at home during three consecutive days before each visit as well as in case of symptoms of hypotension.
The study is designed in three periods:
- Run-in period during 1 month: a reference product Gambrosol Trio 40, one bag/ day will be used by all patients. This period is dedicated to train the patient in using of study product, to stabilize the patient in the PD treatment and to randomize the patient, by performing the 24h ABPM.
- Efficacy & Safety period during 6 months: each patient will be treated with one of two product : PDsol 12 (studied product) or Gambrosol Trio 40 (reference product) during 6 months. The aim of this period is to evaluate the efficacy and long-term tolerance of new PD fluid.
- Follow-up period during 2 months: without treatment. This period is dedicated to ensure the safety of the patients after the study product treatment was stopped and to obtain the information about the reversibility of product effect.
연구 유형
중재적
등록 (예상)
140
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Copenhagen, 덴마크
- Rigshospitalet
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Hannover, 독일, 30659
- KfH-Nierenzentrum am Krankenhaus Oststadt
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Heidelberg, 독일
- university Hospital of Heidelberg
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Köln, 독일, 51109
- KfH-Nierenzentrum
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Offenburg, 독일
- Nephrology center Offenburg
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Passau, 독일, 94032
- KfH-Nierenzentrum
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Stuttgart, 독일
- PHV - Nephrologisches Zentrum Stuttgart
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Trier, 독일, 54292
- KfH-Nierenzentrum Krankenhaus der Barmherzigen Brüder
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Borås, 스웨덴
- Södra Älvborgsläns Hospital
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Göteborg, 스웨덴
- University Hospital of Sahlgrenska
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Lund, 스웨덴
- University Hospital of Lund
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Malmö, 스웨덴
- University Hospital of Malmö
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Skövde, 스웨덴
- Skarborgs Hospital
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Stockholm, 스웨덴, 14186
- Karolinska University Hospital
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Trollhättan, 스웨덴
- Norra Älvsborgs Hospital
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Birmingham, 영국, B9 5SS
- Birmingham Heartlands Hospital
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Bristol, 영국, BS10 5NB
- Southmead Hospital
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London, 영국, E1 1BB
- The Royal London Hospital
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Shrewsbury, 영국, SY3 8XQ
- Royal Shrewsbury Hospital
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Stoke on Trent, 영국, ST47LN
- University of North Staffordshire - Renal Medicine - Royal Infirmary
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Wolverhampton, 영국, WV10 0QP
- Wolverhampton New Cross Hospital
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Besançon, 프랑스, 25000
- CHU Saint-Jacques
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Caen, 프랑스, 14033
- CHRU
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Chambery, 프랑스
- Hospital of Chambéry
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Colmar, 프랑스
- CH Colmar
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Irigny, 프랑스
- Calydial Dialysis Center
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Paris, 프랑스
- Bichat-Claude Bernard Hospital
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Reims, 프랑스, 51726
- ARPDD
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Strasbourg, 프랑스
- CHRU de Strasbourg
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Chronic renal failure
- Stable patients on PD treatment
- Treatment at the study site for at least three months
- Treated in a CAPD program with a minimum of 3 bag exchanges with 6 or 7 days per week including at least one with duration of 4-6 hours, and at least one low strength bag per day, or in an APD program with at least one daytime exchange with duration of 4-6 hours using one low strength bag
- Hypertensive patients with high blood pressure at inclusion visit (Office SBP ≥ 140 and/or DBP ≥ 90 mmHg) or hypertensive patients receiving anti hypertensive medication including diuretics, disregarded blood pressure values
- Patients aged 18 years or more
- Written consent to participate in the study (informed consent)
- Able to use a three-compartment bag
- Life expectancy and expected technical survival ≥ 9 months
Exclusion Criteria:
- Low blood pressure (Office sitting SBP ≤ 120 mmHg and confirmed by ABPM < or = to 105 mean 24h SBP)
- Orthostatic hypotension defined as Systolic OBP with a drop of > 20mmHg and symptomatic after standing for at least 1 minute
- Natremia < 130 mmol/l, after two consecutive measurements
- Chronic arrhythmia
- Pregnancy or lactation
- Participation in other studies during the study period which may affect the outcome of the present study
- Peritonitis within one month prior to the study start
- Exit site and /or tunnel infection
- Patients unable to tolerate 2 L bag exchanges
- Patients on non-compatible PD system
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: PDsol 12
Treatment with a peritoneal dialysis solution containing a low concentration of sodium.
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Treatment with one bag per day during 6 months
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활성 비교기: Gambrosol trio 40
Treatment with the peritoneal dialysis solution Gambrosol trio 40 isotonic bag (1.5%)
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Treatment with one bag per day during 6 months
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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The primary criterion is the ambulatory 24 h mean systolic blood pressure measurement and drug doses management after 2 months of treatment compared to Baseline.
기간: At the beginning and after 8 weeks of treatment
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At the beginning and after 8 weeks of treatment
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2차 결과 측정
결과 측정 |
기간 |
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Measurement of Residual Renal Function
기간: At the beginning, at two and six months of treatment
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At the beginning, at two and six months of treatment
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Follow-up of frequency of hyponatremia, of AE and SAE
기간: During whole period of the study
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During whole period of the study
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Assessment of changes in sodium removal
기간: At the beginning and at two months of treatment
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At the beginning and at two months of treatment
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Assessment of decrease in total body water (extra and intra cellular water)and of the body weigh changes
기간: At the beginning, at two and at six months of treatment
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At the beginning, at two and at six months of treatment
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Measurement of 24hours peritoneal clearance
기간: At the beginning and at 2 months of treatment
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At the beginning and at 2 months of treatment
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Office systolic and diastolic blood pressure measurement at month 2 and 6 versus T0
기간: At the beginning, at two and six months of treatment
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At the beginning, at two and six months of treatment
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Office systolic and diastolic blood pressure measurement during follow up period
기간: End of treatment, follow-up period
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End of treatment, follow-up period
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 의자: Simon Davies, Prof, University Hospital of North Staffordshire, Stoke-on-Trent, UK
- 연구 의자: Bengt Rippe, Prof, Lund University
- 연구 의자: Börje Haraldsson, Prof, Sahlgrenska University Hospital, Göteborg, Sweden
- 연구 의자: François Vrtovsnik, Prof, Bichat -Claude Bernard Hospital, Paris, France
- 연구 의자: Vedat Schwenger, Dr, Universitätsklinik University Hospital, Heidelberg, Germany
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2008년 10월 1일
기본 완료 (실제)
2014년 12월 1일
연구 완료 (실제)
2014년 12월 1일
연구 등록 날짜
최초 제출
2008년 11월 18일
QC 기준을 충족하는 최초 제출
2008년 11월 19일
처음 게시됨 (추정)
2008년 11월 20일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2015년 2월 27일
QC 기준을 충족하는 마지막 업데이트 제출
2015년 2월 26일
마지막으로 확인됨
2014년 9월 1일
추가 정보
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