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RecruitingNCT06069349Updated Oct 10, 2023

Timing of Mobilization on Delirium in Patients After Cardiac Surgery

An interventional study of Early Rehabilitation and usual treatment in Patients After Cardiac Surgery, sponsored by Jingyuan,Xu. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-10.

Sponsored by Jingyuan,Xu · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 11 months ago, but the record still lists the study as recruiting.
  • Started Sep 2023; still recruiting 3 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Patients After Cardiac Surgery
03

In context

Lead sponsor

Jingyuan,Xu is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

    1. > 18-year-old postoperative cardiac patient admitted to ICU, the time \< 24h
    1. Patients agree to participate in clinical research and sign before the start of the study

Exclusion criteria

Exclusion Criteria:

Patients who meet any of the following criteria are not eligible for inclusion in this study:

    1. Pregnant and lactating women
    1. There are 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)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Placebo comparator
    usual treatment

    Other: usual treatment

  • Experimental
    Early mobilization

    early mobilization in the ICU

    Other: Early Rehabilitation

Interventions

  • OtherEarly Rehabilitation

    Early Rehabilitation for patients after cardiac surgery

  • Otherusual treatment

    Patients are not allowed to exercise Early Rehabilitation

06

What researchers measure

Primary outcomes

  1. duration of delirum

    The duration of delirum in hours

    Time frame: 7 days

Secondary outcomes

  1. hospital length of stay

    hospital length of stay, approximately 10 days

    Time frame: hospital length of stay, approximately 10 days

07

Study locations

1 of 1 sites recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06069349
Lead sponsor
Jingyuan,Xu
Responsible party
Jingyuan,Xu (Deputy Chief Physician, Southeast University, China) — Sponsor-investigator
First posted
Oct 5, 2023
Start date
Sep 15, 2023
Primary completion
Dec 2024 (estimated)
Completion
Dec 2024 (estimated)
Last update
Oct 10, 2023

Study contacts

Jingyuan Xu, M.D.
Contact
13851417209@163.com
008613851417209
Jingyuan Xu, M.D.
study director · Study Principal Investigator Southeast University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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