Sleep Disorders After TIPS | NCT03685994

Studies
Sleep Disorders After TIPS

NCT03685994

Sponsor

West China Hospital

Status

Unknown status

Last Update Posted

Apr 22, 2019Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Sleep Disorder

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 31, 2018Actual

Primary Completion Date

Aug 2019Estimated

Completion Date

Aug 2020Estimated

First Submitted Date

Sep 23, 2018

First Submission Date that Met QC Criteria

Sep 23, 2018

First Posted Date

Sep 26, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 18, 2019

Last Update Posted Date

Apr 22, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Label	Type	Description	Intervention Names
the patients who will undergo TIPS

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

mental or nervous system diseases
Patients with alcoholic cirrhosis who are still drinking
Accompanied by serious heart, lung, brain and kidney diseases
Preoperative diagnosis of sleep disorder
Patients who are illiteracy
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xufeng Luo, MD	Contact	+86 13880098212		luo_xuefeng@yeah.net

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
West China Hospital	Recruiting	Chengdu	Sichuan	610041	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39465397	Derived	Zhao M, Yan Y, Wang X, Liu B, Luo X. Sleep disturbance in patients with cirrhosis and transjugular intrahepatic portosystemic shunt. BMC Gastroenterol. 2024 Oct 28;24(1):381. doi: 10.1186/s12876-024-03470-x.

ID	Term
D009422	Nervous System Diseases
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms