Clinical trial NCT06069349: 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
Overall status: RECRUITING
Phase: NA
Conditions: Patients After Cardiac Surgery
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2023-10-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: duration of delirum
timeFrame: 7 days
Secondary outcomes:
measure: hospital length of stay
timeFrame: hospital length of stay, approximately 10 days
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda hospital
state: Jiangsu
Study officials:
affiliation: Study Principal Investigator Southeast University
name: Jingyuan Xu, M.D.
role: STUDY_DIRECTOR
References: