Effect of Lithium Carbonate on Postoperative Sleep and Cognitive Function in Patients Undergoing Heart Valve Surgery With Cardiopulmonary Bypass

NCT05593627 | Recruiting Phase 4 DMC

• 1 other identifier: 20220920-03
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Valve Surgery

Keywords

lithium carbonate; polysomnography

Outcome Measures

Primary Outcomes (1)

• sleep quality

  Duration of sleep was collected with polysomnography on second postoperative night. (from 20:00pm to 06:00am)

  on the second postoperative night from 20:00 to 6:00

Secondary Outcomes (1)

• serum metabolites

  from baseline to postoperative 72 hours

Other Outcomes (1)

• Cognitive function

  on the seventh postoperative day

Study Arms (2)

lithium carbonate

EXPERIMENTAL

Patients undergoing heart valve surgery with cardiopulmonary bypass will take 250mg lithium carbonate .

Drug: Lithium Carbonate 250 MG Oral Tablet

calcium carbonate

PLACEBO COMPARATOR

Patients undergoing heart valve surgery with cardiopulmonary bypass will take 500mg calcium carbonate.

Drug: Calcium Carbonate 500 MG Oral Tablet

Interventions

Lithium Carbonate 250 MG Oral Tablet DRUG

Patients undergoing heart valve surgery withcardiopulmonary bypass will take 250mg lithium carbonate

lithium carbonate

Calcium Carbonate 500 MG Oral Tablet DRUG

Patients undergoing heart valve surgery withcardiopulmonary bypass will take 500mg calcium carbonate

calcium carbonate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ethnic Chinese;
• Age, 18 to 65 years old;
• Patients undergoing heart valve surgery with cardiopulmonary bypass

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• China Medical University, China: lead

Study Sites (1)

the First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

RECRUITING

MeSH Terms

Interventions

Lithium Carbonate; Tablets; Calcium Carbonate

Intervention Hierarchy (Ancestors)

Carbonates; Alkalies; Inorganic Chemicals; Carbonic Acid; Carbon Compounds, Inorganic; Lithium Compounds; Dosage Forms; Pharmaceutical Preparations; Calcium Compounds; Minerals

Central Study Contacts

Wenfei Tan

CONTACT

024-83283100; winfieldtan@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: October 25, 2022
• Study Start: July 1, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): July 30, 2026
• Last Updated: July 18, 2023

Record last verified: 2023-07

Locations

CN (1)