Timing of Mobilization on Delirium in Patients After Cardiac Surgery

NCT ID: NCT06069349

Last Updated: 2023-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-15

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

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.

Conditions

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Patients After Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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usual treatment

Group Type PLACEBO_COMPARATOR

usual treatment

Intervention Type OTHER

Patients are not allowed to exercise Early Rehabilitation

Early mobilization

early mobilization in the ICU

Group Type EXPERIMENTAL

Early Rehabilitation

Intervention Type OTHER

Early Rehabilitation for patients after cardiac surgery

Interventions

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Early Rehabilitation

Early Rehabilitation for patients after cardiac surgery

Intervention Type OTHER

usual treatment

Patients are not allowed to exercise Early Rehabilitation

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jingyuan,Xu

OTHER

Sponsor Role lead

Responsible Party

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Jingyuan,Xu

Deputy Chief Physician

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jingyuan Xu, M.D.

Role: STUDY_DIRECTOR

Study Principal Investigator Southeast University

Locations

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Zhongda hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jingyuan Xu, M.D.

Role: CONTACT

008613851417209

Facility Contacts

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Jingyuan Xu, M.D.

Role: primary

Other Identifiers

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2023ZDSYLL356-P01

Identifier Type: -

Identifier Source: org_study_id

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