The Association Between SIRI and POD in Older Patients

Completed

• Conditions: Postoperative Delirium; Surgery; Elderly

• Registration Number: NCT05797194
• Lead Sponsor: Changhai Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-01
• Primary Completion: 2019-10-31
• Study Completion: 2019-10-31
• Status Verified: 2023-03
• Study First Submitted: 2023-03-05
• Study First Submitted QC: 2023-04-03
• Last Update Submitted: 2023-04-03
• Study First Posted: 2023-04-04
• Last Update Posted: 2023-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CAM score	Postoperative day 3	Positive CAM score means that the patient developed postoperative delirium. While negative CAM score means that the patient did not develop postoperative delirium.
Confusion assessment method (CAM) score	Baseline (Before surgery)	Positive CAM score means that the patient developed postoperative delirium. While negative CAM score means that the patient did not develop postoperative delirium.

Secondary Outcome Measures

Name	Time	Method
MMSE score	postoperative day 3	MMSE score ranges from 0 to 30 and higher score means better outcome.
Mini-mental State Examination (MMSE) score	Baseline (Before surgery)	MMSE score ranges from 0 to 30 and higher score means better outcome.
The level of systemic inflammation response index (SIRI) in peripheral blood.	Baseline (Before surgery)	The SIRI was calculated as neutrophil count × monocyte count/lymphocyte count.

Trial Locations

Locations (1)

Changhai Hospital; 🇨🇳 Shanghai, Shanghai, China