Patients After Cardiac SurgeryNCT06069349
Timing of Mobilization on Delirium in Patients After Cardiac Surgery
A study testing Early Rehabilitation and usual treatment in people with Patients After Cardiac Surgery, run by Jingyuan,Xu at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients After Cardiac Surgery
- What is being tested?
- Early Rehabilitation and usual treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2023to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- (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)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongda hospital
Nanjing, Jiangsu, 210000
Jingyuan Xu, M.D.
About this study
Official title: The Effect of Timing of Mobilization on Delirium in Patients After Cardiac Surgery: a Pilot Study
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.
- Conditions
- Patients After Cardiac Surgery
- Being tested
- Early Rehabilitation, usual treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early RehabilitationOther
Early Rehabilitation for patients after cardiac surgery
usual treatmentOther
Patients are not allowed to exercise Early Rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| usual treatment | Placebo comparator | Not described Receives: Other: usual treatment |
| Early mobilization | Experimental | early mobilization in the ICU Receives: Other: Early Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of delirum
The duration of delirum in hours
Measured: 7 days
Secondary outcomes (1)
hospital length of stay
hospital length of stay, approximately 10 days
Measured: hospital length of stay, approximately 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start15 Sep 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients After Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jingyuan,Xu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jingyuan,Xu, Southeast University, China
- Investigators
- Jingyuan Xu, M.D., Study director, Study Principal Investigator Southeast University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06069349
- Sponsor's protocol ID
- 2023ZDSYLL356-P01
- Status last verified
- Oct 2023
- First submitted
- 1 Sep 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Timing of Mobilization on Delirium in Patients After Cardiac Surgery: a Pilot Study
- ClinicalTrials.gov ID
- NCT06069349
- Acronym / sponsor ID
- 2023ZDSYLL356-P01
- Conditions
- Patients After Cardiac Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jingyuan,XuUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 5 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| usual treatment | Placebo comparator | Other: usual treatment |
| Early mobilization | Experimental | Other: Early Rehabilitationearly mobilization in the ICU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early RehabilitationEarly Rehabilitation for patients after cardiac surgery | Other | Early mobilization |
| usual treatmentPatients are not allowed to exercise Early Rehabilitation | Other | usual treatment |
Primary outcome
duration of delirum
Time frame: 7 days
The duration of delirum in hours
1 secondary outcome
hospital length of stay
Time frame: hospital length of stay, approximately 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jingyuan Xu, M.D. study director
Study Principal Investigator Southeast University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Rehabilitation and usual treatment in people with Patients After Cardiac Surgery, run by Jingyuan,Xu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jingyuan Xu, M.D. (008613851417209, 13851417209@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration of delirum (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.