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OpenTrials
Completed

NCT Number: NCT05797194

The Association Between SIRI and POD in Older Patients

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.

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Key information

Conditions

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

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Confusion assessment method (CAM) score

    Time frame: 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.

  2. CAM score

    Time frame: Postoperative day 1

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

  3. CAM score

    Time frame: Postoperative day 2

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

  4. CAM score

    Time frame: 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.

Secondary outcomes

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

    Time frame: Baseline (Before surgery)

    The SIRI was calculated as neutrophil count × monocyte count/lymphocyte count.

  2. Mini-mental State Examination (MMSE) score

    Time frame: Baseline (Before surgery)

    MMSE score ranges from 0 to 30 and higher score means better outcome.

  3. MMSE score

    Time frame: postoperative day 1

    MMSE score ranges from 0 to 30 and higher score means better outcome.

  4. MMSE score

    Time frame: postoperative day 3

    MMSE score ranges from 0 to 30 and higher score means better outcome.

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Registry information

Official study title

The Potential Value of Systemic Inflammation Response Index on Postoperative Delirium in Older Patients

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 4, 2023
Registry last updated
Apr 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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