Fat Consumption, Inflammatory Markers
Conditions
Brief summary
This single-center, prospective pilot study will examine dietary fat consumption and its relationship with inflammatory markers before surgery and the incidence of perioperative neurocognitive disorders in older surgical patients. The study will assess the feasibility getting diet-related information in a surgical setting and will establish baseline dietary patterns in older adults. It will also measure the incidence of postoperative cognitive impairment (POCI) in patients with high fat consumption and gather patient perspectives to inform future nutrition-focused interventions for older surgical candidates.
Detailed description
This single-center, prospective pilot study will evaluate dietary fat intake and its association with preoperative inflammatory markers and perioperative neurocognitive disorders in older surgical patients. The study will assess the feasibility of obtaining detailed dietary information in a surgical population and will establish baseline dietary information in older adults. Participants will complete diet assessments prior to surgery, provide blood samples totaling up to 32 mL (with up to 16 mL collected before surgery and up to 16 mL collected the morning after surgery), and-when available-have up to 1 mL of cerebrospinal fluid collected during their clinically indicated spinal anesthesia procedure. Blood and cerebrospinal fluid samples will be analyzed for inflammatory markers. Cognitive assessments will be performed to evaluate perioperative neurocognitive disorders. Participants will complete a baseline preoperative telephone cognitive assessment to determine cognitive status. Delirium assessments will be conducted twice daily from immediately after surgery until discharge, supplemented by chart review. At three months after surgery, the telephone cognitive assessment will be repeated and compared with the baseline score to estimate persistent neurocognitive disorder.
Interventions
DIAGNOSTIC_TESTInflammatory markers test in blood prior to surgery
A total of up to 32 mL of blood, with a maximum of 16 mL collected prior to surgery and another 16 mL will be collected the morning after surgery
DIAGNOSTIC_TESTInflammatory markers test in CSF (cerebrospinal fluid)
1 mL sample will be collected during the standard local anesthesia spinal block or intrathecal morphine injection.
DIAGNOSTIC_TESTMOCA test
A baseline preoperative telephone-Montreal Cognitive Assessment (T-MoCA, Appendix B) will be completed prior to surgery
DIAGNOSTIC_TESTCAM-3D
A confusion assessment method assessment (CAM-3D) will be administered twice daily from postoperative day to discharge
Sponsors
Ohio State University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Inclusion criteria
1. ≥ 60 years of age or older 2. Capable and willing to consent 3. English speaking 4. Anticipated ASA physical status I-III 5. Scheduled to undergo major abdominal or pelvic surgery, or total hip or knee joint arthroplasty under general anesthesia with planned spinal anesthetic/analgesic.
Exclusion criteria
1. Illiterate 2. ASA physical status V, VI 3. Active Axis I or II psychiatric disorders including bipolar disorder, schizophrenia, dementia, alcohol, or drug abuse. 4. Preoperative benzodiazepine administration (i.e. Midazolam, Diazepam) 5. Past medical history of any inflammatory autoimmune disease processes (rheumatic arthritis (RA), systemic lupus erythematosus (SLE), autoinflamatory syndrome, etc.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between nutritional factors and inflammatory markers in blood and cerebrospinal fluid (CSF) before and after surgery. | Surgery day and postoperative (PO) Day 1 | Correlation between pre-surgery nutritional factors (fat intake, BMI, waist circumference, frailty status) and inflammatory markers in blood and cerebrospinal fluid (CSF) before and after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Persistent perioperative neurocognitive disorder will be assessed using the Telephone Montreal Cognitive Assessment (T-MoCA) | At screening (baseline) and three months later after surgery | Participants will complete a baseline preoperative Telephone Montreal Cognitive Assessment (T-MoCA) to assess cognitive function. Scores on the T-MoCA range from 0 to 30, with higher scores indicating better cognitive performance. The T-MoCA will be re-administered three months after surgery, and scores will be compared with baseline to identify any persistent perioperative neurocognitive disorder. |
| Patient-centered feedback on Nutrition Perceptions, Behaviors, and Pre-Surgical Readiness for Dietary Change Survey | At hospital discharge (assessed up to 5 days postoperatively) | A self-reported questionnaire using ordinal and nominal variables to assess patients' diet perceptions, prior dietary changes, supplement use, and beliefs about the importance and feasibility of nutrition for recovery. Items use Likert-type scales to evaluate attitudes and readiness for behavior change. The survey identifies nutritional attitudes, willingness to modify diet or use supplements, and potential barriers to preoperative nutritional interventions. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMichelle Humeidan
Ohio State University
Outcome results
None listed