- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02706522
Effect of Oral Carbohydrate on Serum S-100β Protein and Development of Postoperative Delirium in Elderly Patients
August 3, 2017 updated by: SeHee Na, Gangnam Severance Hospital
This study is to evaluate the effects of preoperative carbohydrate intake on perioperative neuroinflammation and development of delirium.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Perioperative insulin resistance may primarily contribute to development of postoperative delirium in high risk patients.
Preoperative administration of oral carbohydrate reduces insulin resistance.
The investigators aimed to investigate the influence of carbohydrate loading on the serum level of S-100β, a surrogate marker of delirium, and the incidence of postoperative delirium in elderly patients.
Study Type
Interventional
Enrollment (Actual)
3
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients undergoing total hip replacement or total knee replacement surgery
Exclusion Criteria:
- Diabetes
- Dementia
- Gastro-esophageal reflux
- Upper gastrointestinal motility disorder
- Inflammatory bowel disease
- Intraperitoneal malignancy history
- Inability to perform cognitive function test
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Allocated to Placebo group
|
Patients received 400 mL of oral flavored water (Placebo) 12 hours before anesthesia and 400 mL 2 hours before
Other Names:
|
Experimental: Allocated to Carbohydrated group
|
Patients received 400 mL of oral isotonic glucose (No NPO®, Daesang, Korea) 12 hours before anesthesia and 400 mL 2 hours before.
CHL composition was standard: 12.5 g of carbohydrate per 100 mL, 12% monosaccharide, 12% disaccharide, 76% polysaccharide, 250 mOsm/kg and 50 kcal.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
serum S-100β level
Time Frame: Postoperative 1 hr
|
Postoperative 1 hr
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 24, 2016
Primary Completion (Actual)
November 15, 2016
Study Completion (Actual)
January 26, 2017
Study Registration Dates
First Submitted
March 2, 2016
First Submitted That Met QC Criteria
March 7, 2016
First Posted (Estimate)
March 11, 2016
Study Record Updates
Last Update Posted (Actual)
August 4, 2017
Last Update Submitted That Met QC Criteria
August 3, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3-2015-0317
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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