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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06069349
Other study ID # 2023ZDSYLL356-P01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT04461743 - Microcirculation Evolution in Patients After Cardiac Surgery