Association of Haptoglobin 2-2 With Postoperative Delirium

Postoperative Delirium Clinical Trial

Official title:

Determination of the Association of Haptoglobin 2-2 With Delirium After Orthopedic Surgery

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03392480
• Other study ID #: S2017-096-02
• Status: Withdrawn
• Start date: December 20, 2017
• Est. completion date: December 30, 2019

Study information

• Verified date: June 2023
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Patients with major orthopedic surgery will be recruited. Participants will be monitored for delirium after surgery. Participants' blood will be harvested for the determination of haptoglobin types, levels of oxidative stress and inflammation. Investigators will then analyze the data to see if haptoglobin 2-2 type is associated with an increased postoperative delirium, inflammation and oxidative stress.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Gender: All
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists physical status I to III class for major orthopedic surgery (hip or knee replacement or spinal surgery)

• No psychological and psychiatric history and presentation before surgery

• No major organ dysfunction or failure

Exclusion Criteria:

• Anemia (hemoglobin < 100 g/l) preoperatively.

• Requires > 4 units of allogeneic red blood cell transfusion during the surgery

• Using steroids or anti-psychological and anti-psychiatric drugs. A small dose of steroid for postoperative anti-nausea/vomiting is allowed and will not be considered as a indication for exclusion.

• Can not cooperate with the study

• History of bleeding

• BMI < 18 or > 30

• History of hemoglobin metabolism disorder

Related Conditions & MeSH terms

• Delirium
• Emergence Delirium
• Postoperative Delirium

Locations

Country	Name	City	State
China	Beijing Jishuitan hospital	Beijing
China	Chinese PLA general hospital	Beijing
China	Daping Hospital, Army Military Medical University	Chongqing
China	Xinqiao hospital, Army military medical university	Chongqing
China	the First Affiliated Hospital of Southern Medical University	Guangzhou
China	Third affiliated hospital of southern medical university	Guangzhou
China	shanghai Changzheng hospital, Naval Military Medical University	Shanghai
China	Shenyang general hospital of military region	Shenyang

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative delirium incidence	The incidence of delirium as assessed by intensive care unit-confusion assessment method will be determined.	From day 0 to up to 7 days after the surgery
Primary	Postoperative delirium duration	The duration of delirium as assessed by intensive care unit-confusion assessment method will be determined.	From day 0 to up to 7 days after the surgery
Secondary	Oxidative stress level	The level of malondialdehyde in the blood will be measured by ELISA.	Day 0 to day 2 after the surgery
Secondary	Inflammation level	The levels of interleukin 1beta and interleukin 6 in the blood will be assessed by ELISA.	Day 0 to day 2 after the surgery