- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07289698
Handgrip Strength Increases the Pressure in the Portal and Left Gastric Veins in Cirrhotic Patients
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Henan
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Luoyang, Henan, China, 471003
- The First Affiliated Hospital of Henan University of Science and Technology
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Shanxi
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Taiyuan, Shanxi, China, 030012
- Shanxi Provincial People's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Portal pressure measurement group
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Jamar Hand Dynamometer, from Illinois, USA.
Maximum handgrip strength was measured three times, with each measurement lasting 3 seconds and a 1-minute interval between tests
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Doppler Ultrasound Measurement Group
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Jamar Hand Dynamometer, from Illinois, USA.
Maximum handgrip strength was measured three times, with each measurement lasting 3 seconds and a 1-minute interval between tests
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
portal pressure
Time Frame: 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.
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through study completion, an average of 5 minutes
|
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left gastric vein pressure
Time Frame: 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.
|
through study completion, an average of 5 minutes
|
|
portal flow velocity
Time Frame: 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
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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
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Portal vein blood flow direction
Time Frame: 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
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Age
Time Frame: Baseline
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Baseline
|
|
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Sex
Time Frame: Baseline
|
Baseline
|
|
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height
Time Frame: Baseline
|
Baseline
|
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weight
Time Frame: Baseline
|
Baseline
|
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Etiology of cirrhosis
Time Frame: Baseline
|
Baseline
|
|
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Serum albumin (g / l)
Time Frame: Baseline
|
Pre-TIPS baseline characteristics ,date (n=32)
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Baseline
|
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alanine aminotransferase(IU / L)
Time Frame: Baseline
|
Pre-TIPS baseline characteristics, date (n=32)
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Baseline
|
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aspartate aminotransferase (IU / L)
Time Frame: Baseline
|
Pre-TIPS baseline characteristics ,date (n=32)
|
Baseline
|
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Total bilirubin (µmol / l)
Time Frame: Baseline
|
Pre-TIPS baseline characteristics ,date (n=32)
|
Baseline
|
|
Prothrombin time (second)
Time Frame: Baseline
|
Pre-TIPS baseline characteristics ,date (n=32)
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Baseline
|
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Fasting blood glucose (mmol / l)
Time Frame: Baseline
|
Pre-TIPS baseline characteristics ,date (n=32)
|
Baseline
|
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triglyceride (mmol / l)
Time Frame: Baseline
|
Pre-TIPS baseline characteristics ,date (n=32)
|
Baseline
|
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Total cholesterol (mmol / l)
Time Frame: Baseline
|
Pre-TIPS baseline characteristics ,date (n=32)
|
Baseline
|
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Serum creatinine (µmol / l)
Time Frame: Baseline
|
Pre-TIPS baseline characteristics ,date (n=32)
|
Baseline
|
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Serum potassium (mmol / l)
Time Frame: Baseline
|
Pre-TIPS baseline characteristics ,date (n=32)
|
Baseline
|
|
Serum sodium (mmol / l)
Time Frame: Baseline
|
Pre-TIPS baseline characteristics ,date (n=32)
|
Baseline
|
|
Serum chloride (mmol / l)
Time Frame: Baseline
|
Pre-TIPS baseline characteristics ,date (n=32)
|
Baseline
|
|
Platelet count (× 109 / mm3)
Time Frame: Baseline
|
Pre-TIPS baseline characteristics ,date (n=32)
|
Baseline
|
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Esophageal varices before endoscopic treatment
Time Frame: Baseline
|
The diagnosis of esophageal varices and variceal bleeding in patients is confirmed by upper gastrointestinal endoscopy.
|
Baseline
|
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Collateral vessels before TIPS placement
Time Frame: Baseline
|
Vascular angiography was performed prior to TIPS placement to diagnose collateral circulation.
date (n=32)
|
Baseline
|
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Ascites
Time Frame: Baseline
|
Prior to TIPS, ascites was evaluated by ultrasound in 32 patients with liver cirrhosis.
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Baseline
|
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Prior overt hepatic encephalopathy
Time Frame: Baseline
|
Baseline
|
|
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Model for end-stage liver disease score
Time Frame: Baseline
|
Model for end-stage liver disease score: 6-40, the higher scores mean a worse outcome.
|
Baseline
|
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Child-Pugh score
Time Frame: Baseline
|
Child-Pugh score: 5-15, the higher scores mean a worse outcome
|
Baseline
|
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Handgrip Strength
Time Frame: Baseline
|
Baseline
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MZ
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
The way of sharing IPD: Sharing and email consultation will begin after December 31, 2027.
Data collection and Management: Case record forms and electronic data captures.
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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