Sleep Disorders After TIPS

April 18, 2019 updated by: luo xuefeng, West China Hospital

The Incidence of Sleep Disorders After Transjugular Intrahepatic Portosystemic Shunt

The Purpose of a study to investigate the incidence of postoperative sleep disorders in patients undergoing transjugular intrahepatic portosystemic shunt ,and to analyze the relationship between risk factors and prognosis of sleep disorders.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital
        • Contact:
          • Xuefeng Luo, MD
          • Phone Number: 862885422389

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

100 patients who underwent TIPS in our hospital due to cirrhosis and portal hypertension.

Description

Inclusion Criteria:

  1. History of cirrhosis (clinical or by liver biopsy)
  2. Portal hypertension patients with defined indications for TIPS treatment
  3. Aged 18-75 years old
  4. Signed written informed consent

Exclusion Criteria:

  1. mental or nervous system diseases
  2. Patients with alcoholic cirrhosis who are still drinking
  3. Accompanied by serious heart, lung, brain and kidney diseases
  4. Preoperative diagnosis of sleep disorder
  5. Patients who are illiteracy
  6. The total score of the preoperative Hamilton anxiety scale was greater than or equal to 14 points, and the total score of 17 points of the Hamilton depression scale was greater than or equal to 18 points

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
the patients who will undergo TIPS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of sleep disorders after TIPS
Time Frame: 1 year
The number of patients who suffer from sleep disorders after TIPS
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of hepatic encephalopathy
Time Frame: 1 year
The number of patients who suffer from hepatic encephalopathy
1 year
mortality
Time Frame: 1 year
The number of patients who died
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2018

Primary Completion (Anticipated)

August 1, 2019

Study Completion (Anticipated)

August 1, 2020

Study Registration Dates

First Submitted

September 23, 2018

First Submitted That Met QC Criteria

September 23, 2018

First Posted (Actual)

September 26, 2018

Study Record Updates

Last Update Posted (Actual)

April 22, 2019

Last Update Submitted That Met QC Criteria

April 18, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SD-TIPS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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