Clinical Trials Logo

Clinical Trial Summary

Acute variceal bleeding is one of the critical complications in patients with cirrhosis. Due to remarkable improvements in diagnostic and therapeutic modalities such as vasoactive agents, endoscopic therapy and antibiotics, the overall prognosis has been improved during the past several decades. However, it is still associated with increased mortality that is still around 20% at 6 weeks. Patients with advanced cirrhosis have an intense overactivity of the endogenous vasoactive systems characterized by arterial hypotension and low peripheral vascular resistance. Severe renal vasoconstriction in consequence of marked arterial vasodilatation in splanchnic circulation triggers the reduction of glomerular filtration rate, and thus induces acute kidney injury (AKI)/hepatorenal syndrome (HRS), which have been further implicated in the increasing mortality in patients with cirrhosis. Renal functional magnetic resonance imaging (fMRI), a technique considered superior to the most common method used to estimate the glomerular filtration rate, allows for non-invasive, accurate measurements of renal structures and functions in both animals and humans. It has become increasingly prevalent in research and clinical applications. In recent years, renal fMRI has developed rapidly with progress in MRI hardware and emerging post-processing algorithms. Function related imaging markers could be acquired via renal fMRI, encompassing water molecular diffusion, perfusion, and oxygenation. The study will use phase contrast - MR angiography, intravoxel incoherent motion - diffusion weighted imaging (IVIM-DWI) and blood-oxgen-level-dependent (BOLD)-MRI to evaluate renal functional changes after using vasoactive medications in patients with cirrhosis. The rationale for the use of vasoactive medications, including terlipressin and octreotide, is to produce splanchnic vasoconstriction and reduce portal blood flow and portal pressure, thereby underpinning the application of these vasoactive drugs in the management of cirrhotic patients with acute variceal bleeding. Meanwhile, terlipressin has been recommended as the international first-line pharmacological therapy for the treatment of HRS because terlipressin may improve renal hemodynamics, improve renal function and potentially enable HRS a reversible condition without the need of liver transplantation. However, the renal protection effect of terlipressin vs. octreotide remains unknown. In this study, the investigators aim to conduct a multicenter, single-blind randomized controlled trial to compare the renal protection effect of terlipressin vs. octreotide assessed by fMRI in the management of cirrhotic patients with acute variceal bleeding.


Clinical Trial Description

Gastroesophageal varices, the most relevant portal-system collaterals, and acute variceal bleeding are critical complications that result directly from portal hypertension in patients with cirrhosis. Gastroesophageal varices are present approximately in 50% of patients with cirrhosis. Their presence correlates with the severity of liver disease. Only 40% of Child-Pugh A patients have varices whilst 85% of the occurrence rate in Child-Pugh C patients. Due to remarkable improvements in diagnostic and therapeutic modalities such as vasoactive agents, endoscopic therapy and antibiotics, the overall prognosis has been improved during the past several decades. However, it is still associated with increased mortality, which is still around 20% at 6 weeks. Acute variceal bleeding is also responsible for a variety of other complications in patients with cirrhosis including acute on chronic liver failure, hepatorenal syndrome, ascites liquid infection and hepatic encephalopathy. Therefore, timely and effective control of acute variceal bleeding is of crucial importance for the prognosis in patients with cirrhosis. In the early stages of cirrhosis, when portal hypertension is moderate, increased cardiac output compensated for a modest reduction in the systemic vascular resistance, ensuring the arterial pressure and effective arterial blood volume to maintain within the normal limits. Patients with advanced cirrhosis have an intense overactivity of the endogenous vasoactive systems characterized by arterial hypotension and low peripheral vascular resistance. This cascade of events sets the stage for further renal vasoconstriction and renal sodium retention as the splanchnic and systemic vasodilatation worsens with the progression of cirrhosis. Severe renal vasoconstriction in consequence of marked arterial vasodilatation in splanchnic circulation triggers the reduction of glomerular filtration rate, and thus induces acute kidney injury (AKI)/ hepato-renal syndrome (HRS) which may implicate in the increasing mortality in patients with cirrhosis. Renal functional magnetic resonance imaging (fMRI), a technique considered superior to the most common method used to estimate the glomerular filtration rate, allows for non-invasive, accurate measurements of renal structures and functions in both animals and humans. It has become increasingly prevalent in research and clinical applications. In recent years, renal fMRI has developed rapidly with progress in MRI hardware and emerging post-processing algorithms. Function related imaging markers could be acquired via renal fMRI, encompassing water molecular diffusion, perfusion, and oxygenation. The study will use phase contrast - MR angiography, intravoxel incoherent motion - diffusion weighted imaging (IVIM-DWI) and blood-oxgen-level-dependent (BOLD)-MRI to evaluate renal functional changes after using vasoactive medications in patients with cirrhosis. The rationale for the use of vasoactive medications, including terlipressin and octreotide, is to produce splanchnic vasoconstriction and reduce portal blood flow and portal pressure, thereby underpinning the application of these vasoactive drugs in the management of cirrhotic patients with acute variceal bleeding. Meanwhile, terlipressin has been recommended as the international first-line pharmacological therapy for the treatment of HRS because terlipressin may improve renal hemodynamics, improve renal function in patients and potentially enable HRS a reversible condition without the need of liver transplantation. However, the renal protection effect of terlipressin vs. octreotide remains unknown. In this study, the investigators aim to conduct a multicenter, single-blind randomized controlled trial to compare the renal protection effect of terlipressin vs. octreotide assessed by fMRI in the management of cirrhotic patients with acute variceal bleeding. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04028323
Study type Interventional
Source Nanfang Hospital of Southern Medical University
Contact Xiaolong Qi, MD
Phone 86-18588602600
Email qixiaolong@vip.163.com
Status Recruiting
Phase Phase 4
Start date July 16, 2019
Completion date October 15, 2022

See also
  Status Clinical Trial Phase
Completed NCT02522104 - Evaluation of the Impact of Renal Function on the Pharmacokinetics of SIKLOS ® (DARH) Phase 4
Completed NCT00721773 - Renal Protective Effects of Renin Angiotensin System (RAS) Inhibitor in Peritoneal Dialysis Patients N/A
Enrolling by invitation NCT02256579 - Utility of Urinary beta2 Microglobulin as an Early Marker of Renal Dysfunction in Vietnamese HIV-Infected Patients N/A
Completed NCT04069871 - Transcutaneous Electrical Nerve Stimulation for Tissues Perfusion N/A
Active, not recruiting NCT05087537 - Effect of Concomitant Bladder Neck Incision and Urethral Valve Ablation on Surgical Re-intervention Rate for Patients With Posterior Urethral Valve N/A
Active, not recruiting NCT05054972 - Left Renal Vein Division for Juxtarenal Aortic Exposure
Not yet recruiting NCT05112393 - Development and Validation of Creatinine-Based Estimates of the Glomerular Filtration Rate Equation
Recruiting NCT05462938 - Conscious Sedation for Transcatheter Aortic Valve Implantation N/A
Recruiting NCT04272359 - Substitution of Sulfonylureas With New Generation of Hypoglycemic Drugs for the Treatment of Type 2 Diabetes Mellitus
Completed NCT01255020 - Renal Protective Effects of Restricted Protein Dietary With α-keto Acid in CAPD Patients N/A
Active, not recruiting NCT03002415 - The Effect of Water Intake on the State of Hydration and Renal Function in Elderly Patients N/A
Active, not recruiting NCT04242758 - Phthalates Exposure in Type 2 Diabetic Patients and Diuretic Therapy Phase 4
Withdrawn NCT00936923 - Effect of Diuretics on Fluid Status Control and Residual Renal Function in Peritoneal Dialysis Patients Phase 3
Completed NCT04070885 - Cohort Follow-up: Progression and Consequences of Chronic Kidney Disease.
Completed NCT02549066 - Impact of CArdiopulmonary Bypass Flow on Renal Blood Flow, Function and OXygenation N/A
Not yet recruiting NCT02061566 - Indoxyl Sulfate Induces Leukocyte-endothelial Interactions Through Up-regulation of ICAM-1 in Acute Kidney Injury N/A
Not yet recruiting NCT05134077 - Influence of Simple Renal Cysts on Renal Function N/A
Completed NCT02013596 - Transcutaneous Electrical Acupoint Stimulation(TEAS) for Hepatic and Renal Dysfunction After Pneumoperitoneum N/A
Completed NCT02443363 - Estimated Glomerular Filtration Rate After Kidney Transplantation - the Formula MDRD, CKD-EPI or Cockroft-Gault? N/A
Completed NCT01948336 - The Effects of Dexmedetomidine on Early Stage Renal Functions in Pediatric Patients Phase 4