Heart Valve SurgeryPhase 4NCT05593627
Effect of Lithium Carbonate on Postoperative Sleep and Cognitive Function in Patients Undergoing Heart Valve Surgery With Cardiopulmonary Bypass
A Phase 4 study testing Lithium Carbonate 250 MG Oral Tablet and Calcium Carbonate 500 MG Oral Tablet in people with Heart Valve Surgery, run by China Medical University, China at 1 site in China.
Trial summary
It has been proved that lithium carbonate can prolong slow wave sleep with few or no side-effects. The aim of the present study is to evaluate postoperative sleep quality of patients undergoing heart valve surgery with cardiopulmonary bypass taken 250mg lithium carbonate after surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Heart Valve Surgery
- What is being tested?
- Lithium Carbonate 250 MG Oral Tablet and Calcium Carbonate 500 MG Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 30 Jul 2026
- Phase
- Phase 4
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ethnic Chinese;
- Age, 18 to 65 years old;
- Patients undergoing heart valve surgery with cardiopulmonary bypass
Who cannot join
- Preoperative Pittsburgh Sleep Quality Index global scores higher than 6
- Cognitive difficulties
- Partial or complete gastrectomy
- Previous esophageal surgery
- Previous treated by radiotherapy or surgery
- Inability to conform to the study's requirements
Show all 10Show fewer
- Body mass index exceeding 30 kg/m2
- Deprivation of a right to decide by an administrative or juridical entity
- Ongoing participation or participation in another study <1 month ago
- Recent (< 3 months prior) use of antibiotics, probiotics, prebiotics, symbiotics, hormonal medication, laxatives, proton pump inhibitors, insulin sensitizers or traditional Chinese medicine
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First Hospital of China Medical University
Shenyang, Liaoning, 110001
Wenfei Tan, M.D.,Ph.D, 024-83283100, winfieldtan@hotmail.com
About this study
It has been proved that lithium carbonate can prolong slow wave sleep with few or no side-effects. The aim of the present study is to evaluate postoperative sleep quality of patients undergoing heart valve surgery with cardiopulmonary bypass taken 250mg lithium carbonate after surgery.
Read the detailed description
This study is a prospective, randomized, controlled (randomized, parallel group, concealed allocation), double-blinded trial. All patients undergoing heart valve surgery with cardiopulmonary bypass will be randomized 1:1 to the treatment intervention with lithium carbonate 250mg (Baoqing, Hunan, China) or calcium carbonate 500mg (Reneed, Beijing, China) after surgery. The objective of the trial is to evaluate the lithium carbonate 250mg on the postoperative night sleep quality. Duration of sleep was collected with polysomnography on second postoperative night. (from 20:00pm to 06:00. Mini-Mental State Examination (MMSE) score was performed on the seventh postoperative day
- Conditions
- Heart Valve Surgery
- Being tested
- Lithium Carbonate 250 MG Oral Tablet, Calcium Carbonate 500 MG Oral Tablet
- Keywords
- lithium carbonate, polysomnography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lithium Carbonate 250 MG Oral TabletDrug
Patients undergoing heart valve surgery withcardiopulmonary bypass will take 250mg lithium carbonate
Calcium Carbonate 500 MG Oral TabletDrug
Patients undergoing heart valve surgery withcardiopulmonary bypass will take 500mg calcium carbonate
| Study group | Role | What they receive |
|---|---|---|
| lithium carbonate | Experimental | Patients undergoing heart valve surgery with cardiopulmonary bypass will take 250mg lithium carbonate . Receives: Drug: Lithium Carbonate 250 MG Oral Tablet |
| calcium carbonate | Placebo comparator | Patients undergoing heart valve surgery with cardiopulmonary bypass will take 500mg calcium carbonate. Receives: Drug: Calcium Carbonate 500 MG Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
sleep quality
Duration of sleep was collected with polysomnography on second postoperative night. (from 20:00pm to 06:00am)
Measured: on the second postoperative night from 20:00 to 6:00
Secondary outcomes (1)
serum metabolites
This study will characterize the serum metabolites of patients before and after heart valve surgery
Measured: from baseline to postoperative 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study start1 Jul 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Valve 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenfei Tan, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05593627
- Sponsor's protocol ID
- 20220920-03
- Status last verified
- Jul 2023
- First submitted
- 21 Oct 2022
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lithium Carbonate on Postoperative Sleep and Cognitive Function in Patients Undergoing Heart Valve Surgery With Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT05593627
- Acronym / sponsor ID
- 20220920-03
- Conditions
- Heart Valve Surgery
- Keywords
- lithium carbonate, polysomnography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 25 Oct 2022 (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.
It has been proved that lithium carbonate can prolong slow wave sleep with few or no side-effects. The aim of the present study is to evaluate postoperative sleep quality of patients undergoing heart valve surgery with cardiopulmonary bypass taken 250mg lithium carbonate after surgery.
Detailed description
This study is a prospective, randomized, controlled (randomized, parallel group, concealed allocation), double-blinded trial. All patients undergoing heart valve surgery with cardiopulmonary bypass will be randomized 1:1 to the treatment intervention with lithium carbonate 250mg (Baoqing, Hunan, China) or calcium carbonate 500mg (Reneed, Beijing, China) after surgery. The objective of the trial is to evaluate the lithium carbonate 250mg on the postoperative night sleep quality. Duration of sleep was collected with polysomnography on second postoperative night. (from 20:00pm to 06:00. Mini-Mental State Examination (MMSE) score was performed on the seventh postoperative day
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lithium carbonate | Experimental | Drug: Lithium Carbonate 250 MG Oral TabletPatients undergoing heart valve surgery with cardiopulmonary bypass will take 250mg lithium carbonate . |
| calcium carbonate | Placebo comparator | Drug: Calcium Carbonate 500 MG Oral TabletPatients undergoing heart valve surgery with cardiopulmonary bypass will take 500mg calcium carbonate. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ethnic Chinese;
- Age, 18 to 65 years old;
- Patients undergoing heart valve surgery with cardiopulmonary bypass
Key exclusion criteria (10 listed)
- Preoperative Pittsburgh Sleep Quality Index global scores higher than 6
- Cognitive difficulties
- Partial or complete gastrectomy
- Previous esophageal surgery
- Previous treated by radiotherapy or surgery
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 |
|---|---|---|
| Lithium Carbonate 250 MG Oral TabletPatients undergoing heart valve surgery withcardiopulmonary bypass will take 250mg lithium carbonate | Drug | lithium carbonate |
| Calcium Carbonate 500 MG Oral TabletPatients undergoing heart valve surgery withcardiopulmonary bypass will take 500mg calcium carbonate | Drug | calcium carbonate |
Primary outcome
sleep quality
Time frame: on the second postoperative night from 20:00 to 6:00
Duration of sleep was collected with polysomnography on second postoperative night. (from 20:00pm to 06:00am)
1 secondary outcome
serum metabolites
Time frame: from baseline to postoperative 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lithium Carbonate 250 MG Oral Tablet and Calcium Carbonate 500 MG Oral Tablet in people with Heart Valve Surgery, run by China Medical University, China 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 3 inclusion and 10 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 18 Jul 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Wenfei Tan (024-83283100, winfieldtan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sleep quality (time frame: on the second postoperative night from 20:00 to 6:00). 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 18 Jul 2023.