Timing of Mobilization on Delirium in Patients After Card... | NCT06069349

Studies
Timing of Mobilization on Delirium in Patients After Cardiac Surgery

NCT06069349

Sponsor

Jingyuan,Xu

Status

Unknown status

Last Update Posted

Oct 10, 2023Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Patients After Cardiac Surgery

Interventions

Early Rehabilitation
usual treatment

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

Oct 2023

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

Sep 15, 2023Actual

Primary Completion Date

Dec 2024Estimated

Completion Date

Dec 2024Estimated

First Submitted Date

Sep 1, 2023

First Submission Date that Met QC Criteria

Sep 29, 2023

First Posted Date

Oct 5, 2023Actual

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

Oct 7, 2023

Last Update Posted Date

Oct 10, 2023Actual

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

Early mobilization is recommended because it is effective in improving symptoms for patients after cardiac surgery. However, the optimal timing of mobilization for postoperative patients is not unclear. How early is early? As early mobilization in the ICU is safe and may reduce healthcare costs, the goal was to assess the effect of early mobilization in the ICU on the incidence and duration of delirium.

Detailed Description

The prevalence of cardiac diseases is high, as the standard treatment for many heart diseases, a bunch of strategies are performed to improve the outcome of cardiac surgery.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
usual treatment	Placebo Comparator		Other: usual treatment
Early mobilization	Experimental	early mobilization in the ICU	Other: Early Rehabilitation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Early Rehabilitation	Other	Early Rehabilitation for patients after cardiac surgery	Early mobilization

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
duration of delirum	The duration of delirum in hours	7 days

Secondary Outcomes

Measure	Description	Time Frame
hospital length of stay	hospital length of stay, approximately 10 days	hospital length of stay, approximately 10 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1. > 18-year-old postoperative cardiac patient admitted to ICU, the time < 24h
2. Patients agree to participate in clinical research and sign informed consent before the start of the study

Exclusion Criteria:

Patients who meet any of the following criteria are not eligible for inclusion in this study:

1. Pregnant and lactating women
2. There are contraindications to getting out of bed：
2.1 Low cardiac output syndrome
(1) Application of IABP or PCPS (percutaneous cardiopulmonary support)
(2) High doses of vasoactive drugs (norepinephrine> 0.5ug/kg.min)
(3) SBP<=80mmHg
(4) Acrocyanosis, wet and cold
(5) Metabolic acidosis
(6) Urine output less than 0.5ml/kg.h for more than 2 hours
2.2 Heart rate greater than or equal to 120 beats per minute at rest
2.3 Orthostatic hypotension (systolic blood pressure less than 80 mmHg after postural change)
2.4 Presence of arrhythmias leading to a drop in blood pressure (e.g., decreased blood pressure due to new-onset atrial fibrillation)
2.5 Difficulty breathing at rest or respiratory rate greater than 30 breaths per minute
2.6 Postoperative bleeding (200ml in 2-3 hours)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jingyuan Xu, M.D.	Contact	008613851417209		13851417209@163.com

Overall Officials

Name	Affiliation	Role
Jingyuan Xu, M.D.	Study Principal Investigator Southeast University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zhongda hospital	Recruiting	Nanjing	Jiangsu	210000	China