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临床试验/NCT07289698
NCT07289698已完成不适用

Handgrip Strength Increases the Pressure in the Portal and Left Gastric Veins in Cirrhotic Patients

Shanxi Provincial People's Hospital2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2025年12月31日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
64
试验地点
2
主要终点
portal flow velocity

研究概览

简要总结

1.Background Handgrip strength , a core indicator of muscle function, has been confirmed to be significantly associated with the clinical prognosis of patients with liver cirrhosis. However, no studies have explored its correlation with portal venous hemodynamics. 2. Objective The purpose of the study is to examine the effects of Handgrip strength on portal vein and left gastric vein pressure, blood flow velocity and direction in patients with liver cirrhosis.

3. Method: observational study. Detection Timing: Doppler ultrasound was employed to determine the portal flow velocity and direction at baseline and during the handgrip strength test in cirrhotic patients with a history of variceal bleeding. Three days later, prior to TIPS placement, the pressures in the portal pressure and gastric vein pressure were measured both before and after handgrip strength. Furthermore, carvedilol and vasoactive drugs were discontinued three days before the study commenced. 4. Elaboration of the Research Hypothesis 4.1. Core Hypothesis The handgrip strength level in patients with liver cirrhosis is correlated with portal venous system hemodynamic indices. Specifically, enhanced handgrip strength may affect portal hypertension and the hemodynamics of varicose veins by improving systemic muscle function or circulatory status. 4.2. Speculation on potential mechanisms Association between muscle function and circulation: As a representative of systemic muscle function, increased handgrip strength may reflect an increase in cardiac output or changes in splanchnic vascular resistance, thereby influencing portal venous hemodynamics.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adult patients (≥18 years of age) with cirrhosis and a history of variceal bleeding, who were preparing for TIPS creation for secondary prophylaxis against variceal bleeding

排除标准

  • Severe congestive heart failure, or severe untreated valvular heart disease
  • Moderate to severe pulmonary hypertension
  • Uncontrolled systemic infection
  • Lesions (e.g., cysts) or tumors in the liver parenchyma that preclude TIPS creation
  • Overt hepatic encephalopathy
  • Unrelieved biliary obstruction
  • Child-Pugh score > 13
  • Model for end-stage liver disease (MELD) score > 18
  • International normalized ratio (INR) > 5
  • Platelet count < 20×109/mm3
  • Participants who had undergone hand or wrist surgery within the previous 3 months or were unable to hold the dynamometer with the testing hand were excluded from the study.

研究组 & 干预措施

Portal pressure measurement group

干预措施: Handgrip strength (Device)

Doppler Ultrasound Measurement Group

干预措施: Handgrip strength (Device)

结局指标

主要结局

portal flow velocity

时间窗: At least 72 hours after the baseline handgrip strength and during the handgrip strength phase, measurements were conducted at intervals of 15 seconds, 30 seconds, 45 seconds, and 60 seconds after the release of strength related to the handgrip Strength

Portal vein blood flow direction

时间窗: At least 72 hours after the baseline handgrip strength and during the handgrip strength phase, measurements were conducted at intervals of 15 seconds, 30 seconds, 45 seconds, and 60 seconds after the release of strength related to the handgrip Strength

portal pressure

时间窗: through study completion, an average of 5 minutes

Prior to TIPS, the pressure monitoring catheter was connected to the pressure-measuring device. Subsequently, the pressures in both the portal vein and left gastric vein were measured simultaneously at baseline and during the handgrip strength test.

left gastric vein pressure

时间窗: through study completion, an average of 5 minutes

Prior to TIPS, the pressure monitoring catheter was connected to the pressure-measuring device. Subsequently, the pressures in both the portal vein and left gastric vein were measured simultaneously at baseline and during the handgrip strength test.

portal flow velocity

时间窗: Before the handgrip strength test, and during the maximum handgrip strength phase, measurements were conducted at intervals of 15 seconds, 30 seconds, 45 seconds, and 60 seconds after the release of strength related to the handgrip Strength

Portal vein blood flow direction

时间窗: Before the handgrip strength test, and during the maximum handgrip strength phase, measurements were conducted at intervals of 15 seconds, 30 seconds, 45 seconds, and 60 seconds after the release of strength related to the handgrip Strength

次要结局

  • Handgrip Strength(Baseline)
  • Serum albumin (g / l)(Baseline)
  • Fasting blood glucose (mmol / l)(Baseline)
  • Serum creatinine (µmol / l)(Baseline)
  • alanine aminotransferase(IU / L)(Baseline)
  • aspartate aminotransferase (IU / L)(Baseline)
  • Total bilirubin (µmol / l)(Baseline)
  • Prothrombin time (second)(Baseline)
  • triglyceride (mmol / l)(Baseline)
  • Total cholesterol (mmol / l)(Baseline)
  • Serum potassium (mmol / l)(Baseline)
  • Serum sodium (mmol / l)(Baseline)
  • Serum chloride (mmol / l)(Baseline)
  • Platelet count (× 109 / mm3)(Baseline)
  • height(Baseline)
  • weight(Baseline)
  • Model for end-stage liver disease score(Baseline)
  • Child-Pugh score(Baseline)
  • Esophageal varices before endoscopic treatment(Baseline)
  • Collateral vessels before TIPS placement(Baseline)
  • Ascites(Baseline)
  • Prior overt hepatic encephalopathy(Baseline)
  • Etiology of cirrhosis(Baseline)
  • Age(Baseline)
  • Sex(Baseline)

研究者

发起方
Shanxi Provincial People's Hospital
申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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