The Association Between SIRI and POD in Older Patients

NCT05797194 | Completed DMC

• 1 other identifier: POD-SIRI
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative delirium (POD) remains one of most common complication in elderly patients receiving surgery, which is characterized by acute and fluctuating change in the level of cognition and consciousness. Previous studies have shown that surgery and anesthesia-induced acute peripheral inflammation and neuroinflammation may lead to delirium after surgery. Systemic Inflammation Response Index (SIRI) is a more easily accessible and comprehensive inflammation marker derived from monocyte, neutrophil, and lymphocyte count, which has been investigated to assess the prognosis of cancer and infectious diseases. However, the relationship between SIRI and POD has yet to be investigated.

Conditions

Postoperative Delirium; Elderly; Surgery

Outcome Measures

Primary Outcomes (4)

• Confusion assessment method (CAM) score

  Positive CAM score means that the patient developed postoperative delirium. While negative CAM score means that the patient did not develop postoperative delirium.

  Baseline (Before surgery)

• CAM score

  Positive CAM score means that the patient developed postoperative delirium. While negative CAM score means that the patient did not develop postoperative delirium.

  Postoperative day 1

• CAM score

  Positive CAM score means that the patient developed postoperative delirium. While negative CAM score means that the patient did not develop postoperative delirium.

  Postoperative day 2

• CAM score

  Positive CAM score means that the patient developed postoperative delirium. While negative CAM score means that the patient did not develop postoperative delirium.

  Postoperative day 3

Secondary Outcomes (4)

• The level of systemic inflammation response index (SIRI) in peripheral blood.

  Baseline (Before surgery)

• Mini-mental State Examination (MMSE) score

  Baseline (Before surgery)

• MMSE score

  postoperative day 1

• MMSE score

  postoperative day 3

Study Arms (2)

POD group

Patients were considered to surfer from postoperative delirium by a positive Confusion Assessment Method (CAM) questionnaire after surgery.

No-POD group

Patients did not surfer from postoperative delirium by a positive CAM questionnaire after surgery.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible patients were scheduled to undergo elective orthopedics surgery under spinal anesthesia with an expected hospital stay of at least 3 days and received postoperative patient- controlled analgesia. Delirium was evaluated at the preoperative visit, then twice daily for 3 days following surgery. Cognition assessment was conducted at preoperative visit, 24 h after surgery and 72 h after surgery. Delirium assessments were performed before 10 AM and after 5 PM in the ward. The confusion assessment method (CAM) questionnaire and cognition assessment method for MMSE were performed by the qualified doctor who trained with CAM and MMSE training manual.

You may qualify if:

• Hospital stay of at least 3 days
• More than or equal to 65 years old
• Elementary education or above
• Able to communicate
• American Society of Anesthesiologists (ASA) physical status I-III
• Mini-mental State Examination (MMSE) scores ≥ 22 points

You may not qualify if:

• Preoperative delirium
• Severe mental diseases
• Autoimmune-illness, chronic infectious diseases, nervous system diseases and malignancies

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2023
• First Posted: April 4, 2023
• Study Start: March 1, 2019
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2019
• Last Updated: April 4, 2023

Record last verified: 2023-03

Locations

CN (1)