Back to resultsTiming of Mobilization on Delirium in Patients After Cardiac Surgery
Primary Purpose
Patients After Cardiac Surgery
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Early Rehabilitation
usual treatment
Sponsored by
About this trial
This is an interventional treatment trial for Patients After Cardiac Surgery
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)
Sites / Locations
- Zhongda hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
usual treatment
Early mobilization
Arm Description
early mobilization in the ICU
Outcomes
Primary Outcome Measures
duration of delirum
The duration of delirum in hours
Secondary Outcome Measures
hospital length of stay
hospital length of stay, approximately 10 days
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06069349
Brief Title
Timing of Mobilization on Delirium in Patients After Cardiac Surgery
Official Title
The Effect of Timing of Mobilization on Delirium in Patients After Cardiac Surgery: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jingyuan,Xu
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients After Cardiac Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
usual treatment
Arm Type
Placebo Comparator
Arm Title
Early mobilization
Arm Type
Experimental
Arm Description
early mobilization in the ICU
Intervention Type
Other
Intervention Name(s)
Early Rehabilitation
Intervention Description
Early Rehabilitation for patients after cardiac surgery
Intervention Type
Other
Intervention Name(s)
usual treatment
Intervention Description
Patients are not allowed to exercise Early Rehabilitation
Primary Outcome Measure Information:
Title
duration of delirum
Description
The duration of delirum in hours
Time Frame
7 days
Secondary Outcome Measure Information:
Title
hospital length of stay
Description
hospital length of stay, approximately 10 days
Time Frame
hospital length of stay, approximately 10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jingyuan Xu, M.D.
Phone
008613851417209
Email
13851417209@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jingyuan Xu, M.D.
Organizational Affiliation
Study Principal Investigator Southeast University
Official's Role
Study Director
Facility Information:
Facility Name
Zhongda hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingyuan Xu, M.D.
12. IPD Sharing Statement
Learn more about this trial
Timing of Mobilization on Delirium in Patients After Cardiac Surgery
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