Timing of Mobilization on Delirium in Patients After Cardiac Surgery

Patients After Cardiac Surgery Clinical Trial

Official title:

The Effect of Timing of Mobilization on Delirium in Patients After Cardiac Surgery: a Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06069349
• Other study ID #: 2023ZDSYLL356-P01
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2023
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: Southeast University, China
• Contact: Jingyuan Xu, M.D.
• Phone: 008613851417209
• Email: 13851417209[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Delirium
• Patients After Cardiac Surgery

Intervention

Other:
• Early Rehabilitation
Early Rehabilitation for patients after cardiac surgery
• usual treatment
Patients are not allowed to exercise Early Rehabilitation

Locations

Country	Name	City	State
China	Zhongda hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jingyuan,Xu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	duration of delirum	The duration of delirum in hours	7 days
Secondary	hospital length of stay	hospital length of stay, approximately 10 days	hospital length of stay, approximately 10 days