난치성 복수가 있는 간경변증에서 동적 심장 기능, 신장 및 심장 바이오마커의 영향을 평가하기 위한 현장 심초음파
Point-of-care echocardiography (POC-Echo) is used to determine left ventricular systolic and diastolic dysfunction (LVDD), inferior vena cava (IVC) dynamics and volume status in cirrhosis and Acute-on-chronic liver failure ACLF accurately.
We will assess IVC dynamics, LV systolic function [LV ejection fraction (EF) & cardiac output (CO)], and diastolic dysfunction (E/e', e' and E/A ratio) and urinary biomarkers (cystatin C and NGAL) in patients with cirrhosis and Refractory Ascites.
연구 개요
상세 설명
The decrease in systemic vascular resistance (SVR) and redistribution of blood volume with reduced intravascular volume compartment and third space fluid losses. Systemic vasodilatation is compensated by an increase in cardiac output (CO) in the initial stages of compensated cirrhosis. However, as the stage of liver cirrhosis progresses to decompensation, more prominent arterial vasodilatation and reduced SVR leads to a fall in CO. Thus, the cardiac homeostat is reset in a cirrhotic hyperdynamic circulation, wherein an increased heart rate, and therefore, increased cardiac output will no longer be able to compensate for the reduced mean arterial pressure (MAP), and decreased blood volumes in central venous territories.18 Consequent activation of vasoconstrictor systems including renin-angiotensin-aldosterone, vasopressin and the sympathetic nervous system comes into play to maintain the intravascular blood volume and pressure. These compensatory pathways cause an increase in sodium and water retention resulting in refractory ascites and hepatorenal syndrome (HRS). In critically ill patients with cirrhosis, the limited cardiac reserve is further stressed, CCM and heart failure may be diagnosed for the first time when the patient develops sepsis or septic shock.
Point-of-care echocardiography (POC-Echo) is used to determine left ventricular systolic and diastolic dysfunction (LVDD), inferior vena cava (IVC) dynamics and volume status in cirrhosis accurately. We will assess IVC dynamics, LV systolic function [LV ejection fraction (EF) & cardiac output (CO)], and diastolic dysfunction (E/e', e' and E/A ratio) in patients with cirrhosis ACLF and refractory ascites
Definition of CCM is as per updated CCMC criteria of 2020.
연구 유형
등록 (추정된)
연락처 및 위치
연구 장소
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National Capital Territory of Delhi
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Chandigarh, National Capital Territory of Delhi, 인도, 160012
- PGIMER
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Cirrhosis of any etiology, aged between 18-65 years, with Refractory Ascites definition as per International Ascites club.
- Diuretic-resistant ascites
- Diuretic-intractable ascites
설명
Inclusion Criteria:
- Cirrhosis of any Etiology
- Patient with Refractory Ascites
Exclusion Criteria:
- Hepatocellular carcinoma
- Patients with active variceal bleeding
- HIV or severe immunocompromised state
- Chronic kidney disease (CKD) on renal replacement therapy (RRT),
- Previous transjugular intra hepatic portosystemic shunt (TIPS)
- Porto-pulmonary hypertension,
- Coronary artery disease
- Congenital or valvular heart disease
- Prosthetic cardiac valves
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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난치성 복수를 동반한 간경변증
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POC-Echocardiography to assess dynamic changes in cardiac output to assess therapeutic responses with albumin, midodrine, diuretics and domiciliary albumin |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Cardiac output measurement by echocardiography after albumin
기간: Day 0
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Echocardiographic assessment of cardiac output in L/min will be recorded at least 3 time points, day 0, day 1 and day 2. The cardiac output at 3 days after enrollment and albumin therapy will also be documented. The Doppler velocity time integral (VTI) method in estimating stroke volume and cardiac output correlates well with results of concurrent thermodilution cardiac output determinations in patients without significant left-sided valvular regurgitation. Cardiac output(CO), Stroke volume (SV), Heart rate (HR) CO = [SV * HR]/ 1000 |
Day 0
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Cardiac output measurement by echocardiography after albumin
기간: Day 1
|
Echocardiographic assessment of cardiac output in L/min will be recorded at least 3 time points, day 0, day 1 and day 2. The cardiac output at 3 days after enrollment and albumin therapy will also be documented. The Doppler velocity time integral (VTI) method in estimating stroke volume and cardiac output correlates well with results of concurrent thermodilution cardiac output determinations in patients without significant left-sided valvular regurgitation. Cardiac output(CO), Stroke volume (SV), Heart rate (HR) CO = [SV * HR]/ 1000 |
Day 1
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Cardiac output measurement by echocardiography after albumin
기간: Day 2
|
Echocardiographic assessment of cardiac output in L/min will be recorded at least 3 time points, day 0, day 1 and day 2. The cardiac output at 3 days after enrollment and albumin therapy will also be documented. The Doppler velocity time integral (VTI) method in estimating stroke volume and cardiac output correlates well with results of concurrent thermodilution cardiac output determinations in patients without significant left-sided valvular regurgitation. Cardiac output(CO), Stroke volume (SV), Heart rate (HR) CO = [SV * HR]/ 1000 |
Day 2
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Cardiac output measurement by echocardiography after albumin
기간: Day 3
|
Echocardiographic assessment of cardiac output in L/min will be recorded at least 3 time points, day 0, day 1 and day 2. The cardiac output at 3 days after enrollment and albumin therapy will also be documented. The Doppler velocity time integral (VTI) method in estimating stroke volume and cardiac output correlates well with results of concurrent thermodilution cardiac output determinations in patients without significant left-sided valvular regurgitation. Cardiac output(CO), Stroke volume (SV), Heart rate (HR) CO = [SV * HR]/ 1000 |
Day 3
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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20% 알부민 후 폐 초음파 점수 변화
기간: 0일
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0일
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20% 알부민 후 폐 초음파 점수 변화
기간: 1일차
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1일차
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20% 알부민 후 폐 초음파 점수 변화
기간: 2일차
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2일차
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Cystatin C 및 Neutrophil gelatinase 관련 lipocalin(NGAL) 수준의 변화
기간: 0일
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0일
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NT Pro 뇌 나트륨 이뇨 펩타이드(BNP) 수치의 변화
기간: 0일
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0일
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혈장 레닌 활동 수준의 변화
기간: 0일
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0일
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Galectin-3 수준의 변화
기간: 0일
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0일
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IVC size and collapsibility changes after 20% albumin
기간: Day 0
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IVC maximum and Minimum diameter and collapsibility index determined by percentage change in IVC diameter will be recorded. |
Day 0
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IVC size and collapsibility changes after 20% albumin
기간: Day 2
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IVC maximum and Minimum diameter and collapsibility index determined by percentage change in IVC diameter will be recorded. |
Day 2
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IVC size and collapsibility changes after 20% albumin
기간: Day 1
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IVC maximum and Minimum diameter and collapsibility index determined by percentage change in IVC diameter will be recorded. |
Day 1
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Cardenas A, Arroyo V. Refractory ascites. Dig Dis. 2005;23(1):30-8. doi: 10.1159/000084723.
- Adebayo D, Neong SF, Wong F. Refractory Ascites in Liver Cirrhosis. Am J Gastroenterol. 2019 Jan;114(1):40-47. doi: 10.1038/s41395-018-0185-6.
- Larrue H, Vinel JP, Bureau C. Management of Severe and Refractory Ascites. Clin Liver Dis. 2021 May;25(2):431-440. doi: 10.1016/j.cld.2021.01.010. Epub 2021 Mar 11.
- Salerno F, Guevara M, Bernardi M, Moreau R, Wong F, Angeli P, Garcia-Tsao G, Lee SS. Refractory ascites: pathogenesis, definition and therapy of a severe complication in patients with cirrhosis. Liver Int. 2010 Aug;30(7):937-47. doi: 10.1111/j.1478-3231.2010.02272.x. Epub 2010 May 21.
- Izzy M, VanWagner LB, Lin G, Altieri M, Findlay JY, Oh JK, Watt KD, Lee SS; Cirrhotic Cardiomyopathy Consortium. Redefining Cirrhotic Cardiomyopathy for the Modern Era. Hepatology. 2020 Jan;71(1):334-345. doi: 10.1002/hep.30875. Epub 2019 Oct 11.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
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
- NK-2020-2141
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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