The FILTRATE Trial: High-Rate Ultrafiltration for Intravascular Congestion (FILTRATE)
FluId removaL With a High Rate ulTRAfiltration Protocol in paTiEnts With Intravascular Congestion: the FILTRATE Trial
The purpose of this study is to evaluate whether a personalized, high-rate fluid removal strategy guided by ultrasound is as safe and effective as the standard fluid removal rate for patients with advanced kidney disease who are hospitalized due to severe fluid overload (congestion).
When patients with End-Stage Renal Disease (ESRD) on chronic hemodialysis are admitted to the hospital with excess fluid, doctors often need to remove this fluid quickly to relieve symptoms like severe shortness of breath. However, traditional guidelines recommend conservative fluid removal rates-called ultrafiltration (UF) rates-between 10 and 13 mL/kg/h to prevent sudden drops in blood pressure (intradialytic hypotension). Despite these guidelines, doctors in real-world hospital settings frequently use higher rates to provide urgent relief, though this practice lacks strong scientific backing.
This study utilizes advanced bedside ultrasound protocols (such as lung ultrasound and VExUS) to objectively measure the amount of fluid congestion inside the patient's blood vessels. The researchers hypothesize that patients with high ultrasound markers of congestion can safely tolerate higher fluid removal rates because their blood vessels are overfilled, meaning fluid can be pulled out faster without causing blood pressure drops.
Participants will be randomly assigned to one of two groups during their first in-hospital hemodyalisis session:
- Standard Group: Receives a standard fluid removal rate of 10 mL/kg/h.
- High-Rate Group: Receives a higher fluid removal rate of over 13 mL/kg/h (with a safety ceiling up to 15 mL/kg/h).
The study will compare the two groups over the first 24 hours to monitor blood pressure stability (safety) and check for improvements in ultrasound congestion scores, shortness of breath, and the need for supplemental oxygen (effectiveness).
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Edgar Adrián Montemayor, Nephrology Fellow
- 전화번호: +52 8180911271
- 이메일: edgar.montemayorga@uanl.edu.mx
연구 장소
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Nuevo León
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Monterrey, Nuevo León, 멕시코, 64460
- 모병
- Hospital Universitario "Dr. José E. González"
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연락하다:
- Edgar Adrián Montemayor, Nephrology Fellow
- 전화번호: +52 8180911271
- 이메일: edgar.montemayorga@uanl.edu.mx
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Adults over 18 years old with End-Stage Renal Disease on hemodialysis for at least 3 months.
- Admitted to the hospital requiring mechanical fluid removal for acute fluid overload (first in-hospital session).
- Clear ultrasound evidence of severe intravascular congestion (such as diffuse B-lines in the lungs or altered VExUS vascular flow patterns).
- Hemodynamically stable with a baseline blood pressure of at least 120/80 mmHg.
Exclusion Criteria:
- Baseline low blood pressure (<100/60 mmHg) or active shock (cardiogenic, septic, or distributive).
- Acute coronary syndrome (heart attack), severe heart valve disease, or severe fluid around the heart.
- Known chronic lung disease.
- Pregnancy.
공부 계획
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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활성 비교기: Standar Group
Receives a standard fluid removal rate of 10 mL/kg/h.
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Receives a standard fluid removal rate of 10 mL/kg/h.
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실험적: High-Rate Group
Receives a higher fluid removal rate of over 13 mL/kg/h (with a safety up to 15 mL/kg/h).
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This intervention consists of fluid removal (ultrafiltration) during the first in-hospital hemodialysis session of a patient with advanced Chronic Kidney Disease, utilizing a high rate greater than 13 mL/kg/h (with a strict safety limit established between >13 and up to 15 mL/kg/h).The differentiating value of this protocol lies in the fact that it challenges traditional medical dogma by combining an aggressive rate with advanced multiparametric ultrasound tools, something that had not been formally structured in previous clinical trials.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Safety (Incidence of Intradialytic Hypotension - IDH)
기간: During the interventional hemodialysis session.
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Frequency of episodes defined as a drop in systolic blood pressure (PAS > 20 mmHg) or mean arterial pressure (PAM > 10 mmHg) associated with clinical symptoms requiring medical intervention during the session.
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During the interventional hemodialysis session.
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Ultrasound Efficacy
기간: Comparison between Baseline (pre-intervention) and within 24 hours post-intervention.
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Improvement in intravascular congestion parameters and cardiac filling pressures, evaluated through a reduction of at least 1 grade in the VExUS score, a 30% decrease in the lung B-line count, and improvement in echocardiographic parameters.
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Comparison between Baseline (pre-intervention) and within 24 hours post-intervention.
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Clinical Respiratory Efficacy
기간: The patient's condition is assessed before starting the therapy, and their clinical progress is evaluated within the 24 hours post-intervention.
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Clinical improvement of the patient measured by the mMRC dyspnea scale and the documented change in the use of supplemental oxygen (fraction of inspired oxygen [FiO_2] or flow in liters per minute).
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The patient's condition is assessed before starting the therapy, and their clinical progress is evaluated within the 24 hours post-intervention.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Prediction and Tolerance Analysis
기간: Pre-session (baseline) ultrasound data are collected and correlated with any adverse events that occur while the ultrafiltration is underway.
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Determining if high baseline VExUS scores and elevated cardiac filling pressures can predict which patients will successfully tolerate the high ultrafiltration rate (>13 mL/kg/h), aiming to establish specific cutoff values using ROC curves.
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Pre-session (baseline) ultrasound data are collected and correlated with any adverse events that occur while the ultrafiltration is underway.
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Hospital Stay and Support
기간: From the date of randomization until hospital discharge, assessed up to 30 days.
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Measuring and comparing the difference between both groups in total days of hospital stay and days of supplemental oxygen requirement.
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From the date of randomization until hospital discharge, assessed up to 30 days.
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Blood Pressure Control and Volume
기간: Prior to the session (Baseline) and within 24 hours post-intervention.
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Correlating the total volume of ultrafiltration programmed versus the volume achieved at the end of the session, and comparing the impact on blood pressure control (pre-dialysis vs. post-dialysis at 24 hours).
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Prior to the session (Baseline) and within 24 hours post-intervention.
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Biomedical and Echocardiographic Variables
기간: Prior to the session (Baseline) and within 24 hours post-intervention.
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Analyzing the quantitative change in natriuretic peptide (NT-proBNP) levels before and within 24 hours after the session.
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Prior to the session (Baseline) and within 24 hours post-intervention.
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Subgroup Analysis (Ventricular Function)
기간: From the date of randomization until hospital discharge, assessed up to 30 days.
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Exploring whether Left Ventricular Ejection Fraction (LVEF), natriuretic peptides, or pre-dialysis blood pressure modify or influence the clinical response to the specific ultrafiltration profile used
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From the date of randomization until hospital discharge, assessed up to 30 days.
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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
- NF26-00006
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- ANALYTIC_CODE
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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