Clinical trial NCT05434286: Point-of-Care Echocardiography to Assess Impact of Dynamic Cardiac Function, Renal and Cardiac Biomarkers in Cirrhosis With Hepatorenal Syndrome-Acute Kidney Injury
Official title: Point-of-Care Echocardiography to Assess Impact of Dynamic Cardiac Function, Renal and Cardiac Biomarkers in Cirrhosis With Hepatorenal Syndrome-Acute Kidney Injury
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatorenal Syndrome
Cirrhosis, Liver
Acute-On-Chronic Liver Failure
AKI
Refractory Ascites
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
First posted: 2022-06-28
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cirrhosis of any etiology, aged between 18-65 years, with hepatorenal syndrome (HRS-AKI).

Acute kidney injury (AKI) (increase in serum creatinine by 0.3 mg/dL in less than 48 hour or an increase in serum creatinine by 50% from a stable baseline reading within 3 months) has been proposed to characterize renal dysfunction in patients with cirrhosis, in which type 1 HRS would be reclassified as HRS-AKI.

Stage 1 AKI would be classified as an increase in serum creatinine level by 0.3 mg/dL or a 50% increase, whereas stages 2 and 3 AKI would be a doubling and tripling, respectively, of serum creatinine levels.

Brief summary: 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 ACLF with hepatorenal syndrome-acute kidney injury (HRS-AKI).


Eligibility criteria: Inclusion Criteria:

* Cirrhosis of any Etiology
* Patient with acute kidney injury meeting HRS-AKI criteria

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

Primary outcomes:
measure: Cardiac output measurement by echocardiography
timeFrame: Day 0, Day 2, Day 7.
measure: IVC size and collapsibility changes
timeFrame: Day 0.
measure: IVC size and collapsibility changes
timeFrame: Day 2
measure: IVC size and collapsibility changes
timeFrame: Day 7.
measure: Number of patients with Complete Response in HRS-AKI
timeFrame: Day 7
measure: Number of patients with Partial Response in HRS-AKI
timeFrame: Day 7
measure: Number of patients with Non-Response in HRS-AKI
timeFrame: Day 7
Secondary outcomes:
measure: Change in Cystatin C and Neutrophil gelatinase associated lipocalin (NGAL) level
timeFrame: Day 0 and Day 7
measure: Change in NT Pro brain natriuretic peptide (BNP) level
timeFrame: Day 0 and Day 7
measure: Change in plasma renin activity level
timeFrame: Day 0 and Day 7
measure: Change in Galectin-3 level
timeFrame: Day 0 and Day 7
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: PGIMER
state: Delhi
Study officials:
References:
citation: 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.