Timing of Mobilization on Delirium in Patients After Cardiac Surgery
The Effect of Timing of Mobilization on Delirium in Patients After Cardiac Surgery: a Pilot Study
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2023
CompletedStudy Start
First participant enrolled
September 15, 2023
CompletedFirst Posted
Study publicly available on registry
October 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedOctober 10, 2023
October 1, 2023
1.2 years
September 1, 2023
October 7, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
duration of delirum
The duration of delirum in hours
7 days
Secondary Outcomes (1)
hospital length of stay
hospital length of stay, approximately 10 days
Study Arms (2)
usual treatment
PLACEBO COMPARATOREarly mobilization
EXPERIMENTALearly mobilization in the ICU
Interventions
Eligibility Criteria
You may qualify if:
- \. \> 18-year-old postoperative cardiac patient admitted to ICU, the time \< 24h
- \. Patients agree to participate in clinical research and sign informed consent before the start of the study
You may not qualify if:
- \. Pregnant and lactating women
- \. There are contraindications to getting out of bed：
- 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
- Heart rate greater than or equal to 120 beats per minute at rest
- Orthostatic hypotension (systolic blood pressure less than 80 mmHg after postural change)
- Presence of arrhythmias leading to a drop in blood pressure (e.g., decreased blood pressure due to new-onset atrial fibrillation)
- Difficulty breathing at rest or respiratory rate greater than 30 breaths per minute
- Postoperative bleeding (200ml in 2-3 hours)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jingyuan,Xulead
Study Sites (1)
Zhongda hospital
Nanjing, Jiangsu, 210000, China
Study Officials
- STUDY DIRECTOR
Jingyuan Xu, M.D.
Study Principal Investigator Southeast University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Deputy Chief Physician
Study Record Dates
First Submitted
September 1, 2023
First Posted
October 5, 2023
Study Start
September 15, 2023
Primary Completion
December 1, 2024
Study Completion
December 1, 2024
Last Updated
October 10, 2023
Record last verified: 2023-10