급성 신장 손상 환자의 지속적 신대체 요법 중 변형된 정맥 과잉 초음파검사 유도 체액 균형 대 표준 치료 (mVExUS-CRRT)
급성 신장 손상 환자의 지속적 신대체 요법 중 변형 정맥 과잉 초음파 검사 유도 체액 균형 대 표준 치료: 다기관 무작위 대조 시험
The goal of this randomised controlled trial is to compare the cumulative fluid balance over the first 72 h following inclusion guided by mVExUS versus standard of care in critically ill patients with acute kidney injury receiving CRKT . It will also compare the proportion of CRRT-related complications-including intradialytic hypotension and arrhythmias-between patients managed with mVExUS-guided fluid management and those receiving standard care.
The main questions it aims to answer are:
Does fluid removal rate guided by mVExUS will reduce cumulative fluid balance over the course of the first 72 h of CRRT in ICU patients compared to standard care
Participants will:
Get fluid assessment by mVExUS protocol or a strandard care every 8 hours for 72 hours
연구 개요
상태
상세 설명
After enrollment, the participants have to be randomized within 1 h. In the intervention arm, mVExUS has to be performed every 24 hours until 72 hours after enrollment. Participants with profile A will have UFNET 0 mL/hr with target fluid balance 0 to +500 mL/day. Patients with profile B will have UFNET 0-20 mL/hr with target fluid balance 0 to -500 mL/day. Patients with profile C will have UFNET 20-40 mL/hr with target fluid balance -500 to -1000 mL/day. Patients with profile D will have UFNET 40-100 mL/hr with target fluid balance neg >1000 mL/day.
This intervention will be combined with serial lactate monitoring in which lactate levels will be measured every 8 h. When the lactate level rises more than 2 or if there is presence of HIRRT (tachycardia, hypotension, mottling or drop in cardiac index), passing leg raising or mini-fluid challenge (crystalloid fluid bolus 200 mL) will be performed to assess fluid responsiveness. If there is fluid responsiveness, UFNET will be stopped. Once lactate is normalized or episode of HIRRT resolved, the UFNET strategy has to be restored.
The CRRT technique (haemodialysis, haemofiltration, haemodiafiltration) will be left at the discretion of the treating team. CRRT dose (i.e. dialysate or reinfusion fluids flow rate) will be prescribed at 25-30 ml/kg/hr according to the KDIGO guideline. CRRT dose and UFNET will be indexed to the patient's body weight, and in patients with a body mass index at 30 kg/m2, to the adjusted body weight (calculated as ideal body weight to which will be added 40% of the difference between the actual body weight and the ideal body weight - Du Bois formula). Choice of extra-corporeal circuit anticoagulation (heparin, citrate or none) and implantation site of CRRT catheters will be left at the discretion of the treating physician.
Vasopressors will be titrated as per unit-based protocols to maintain the mean arterial pressure within the bounds prescribed by the physician in charge (most frequently between 65 and 75 mmHg). Indications and category of vasopressors and inotropes will be left at the discretion of the treating team. The diuretic will be stopped once the patient is enrolled.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: thanphisit trakarnvanich, Bachelor's Degree
- 전화번호: +66896996830
- 이메일: thanphisit2@hotmail.com
연구 장소
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Bangkok, 태국, 10330
- 모병
- King Chulalongkorn Memorial Hospital
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연락하다:
- Nuttha Lumlertgul, PhD
- 전화번호: +66896996830
- 이메일: nlumlertgul@gmail.com
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Bangkok, 태국, 10300
- 아직 모집하지 않음
- Vajira Hospital, Navamindradhiraj University
-
연락하다:
- Thanphisit Trakarnvanich
- 전화번호: +66896996830
- 이메일: thanphisit2@hotmail.com
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Adults (≥ 18 years of age)
- Admitted to ICU
- Acute kidney injury by KDIGO criteria
- Initiated CRRT by at least one of the following indications for RRT initiation:
- Serum potassium ≥ 6.0 mmol/L, or
- pH ≤ 7.20 or serum bicarbonate ≤ 12 mmol/L, or
- Evidence of severe respiratory failure, based on a PaO2/FiO2 ≤ 200 and clinical perception of volume overload, or
- Persistent severe AKI (sCr remains > 50% the value recorded at randomization) for > 72 hours from randomization
- Participants giving informed consent
Exclusion Criteria:
- Refuse to participate
- Previous diagnosis of end-stage kidney disease (ESKD) currently on kidney replacement therapy
- Kidney transplant recipient
- Receive RRT before ICU admission within 90 days
- Structural kidney diseases which will interfere with intrarenal doppler ultrasound e.g. renal artery stenosis, autosomal dominant polycystic kidney disease
- Patients with previously known conditions that interfere with portal doppler assessment, namely liver cirrhosis, severe tricuspid regurgitation with structural heart disease or massive ascites.
- Underlying disease process with a life expectancy less than 90 days
- Pregnancy
- Severe cardiac rhythm disturbances (tachyarrhythmia, supraventricular tachycardia)
- Intra-cardiac shunts; Ventricle septal defect, patent foramen ovale, atrial septal defect
- Aortic aneurysm
- Intra-abdominal hypertension (intraabdominal pressure ≥20 mmHg)
- Expected life expectancy <48 hours
- Receiving extracorporeal membrane oxygenation (ECMO)
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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간섭 없음: 스탠다드 케어
|
|
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활성 비교기: mVExUS-유도 체액 관리
|
In the intervention arm, mVExUS has to be performed every 24 hours until 72 hours after enrollment. Participants with profile A will have UFNET 0 mL/hr with target fluid balance 0 to +500 mL/day. Patients with profile B will have UFNET 0-20 mL/hr with target fluid balance 0 to -500 mL/day. Patients with profile C will have UFNET 20-40 mL/hr with target fluid balance -500 to -1000 mL/day. Patients with profile D will have UFNET 40-100 mL/hr with target fluid balance neg >1000 mL/day. This intervention will be combined with serial lactate monitoring in which lactate levels will be measured every 8 h. When the lactate level rises more than 2 or if there is presence of HIRRT (tachycardia, hypotension, mottling or drop in cardiac index), passing leg raising or mini-fluid challenge (crystalloid fluid bolus 200 mL) will be performed to assess fluid responsiveness. If there is fluid responsiveness, UFNET will be stopped. Once lactate is normalized or episode of HIRRT resolved, the UFNET strat |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
72-hour cumulative fluid balance between mVExUS-guided management and standard care in critically ill patients with acute kidney injury receiving CRKT.
기간: Hour 0, Hour 72
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In the mVExUS-guided management the fluid removal rate will be guided based on mVExUS ultrasound results. In standard care the fluid removal rate is based on conventionval fluid assessment |
Hour 0, Hour 72
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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mVExUS 유도 체액 관리와 표준 치료 간의 28일 및 90일 사망률 비교
기간: 28일, 90일
|
28일, 90일
|
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AKI 하위 표현형, 앤지오포이에틴-1, 앤지오포이에틴-2 및 용해성 TNF 수용체-1로 분류된, CRRT를 받는 급성 신장 손상 중환자에서 사망 위험과의 연관성
기간: 28일
|
28일
|
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mVExUS 유도 체액 관리로 치료받은 환자와 표준 치료를 받은 환자 간의 CRRT 관련 합병증(투석 중 저혈압 및 부정맥 포함) 비율
기간: 0시간, 72시간
|
0시간, 72시간
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급성 신장 손상이 있는 중환자에서 CRRT를 받는 환자들의 체액 축적과 순초과여과율 경로의 차이 패턴 및 28일 사망률 차이와의 상관관계
기간: 28일
|
28일
|
공동 작업자 및 조사자
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
- 0449/2568
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
The datasets used and/or analysed will be available from the corresponding author on reasonable request.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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